1.  Peer Reviewed Title: Bridging the gap between male and female fertility control; contraception-on-demand. Author: Aitken RJ; Hughes LM; Griffith R; Baker MA Source: Contraception. 2008 Oct;78(4 Suppl 1):S28-S35. Abstract: Contraception-on-demand refers to contraceptive methods that are only employed when needed, such as barrier or postcoital methods, as opposed to technologies, such as the IUD or pill, where the exposure is continuous irrespective of the risk of pregnancy. The development of women-centered approaches to contraception-on-demand is a high priority in current contraceptive research, with emphasis on the 15- to 25-year-old demographic. Since this cohort of potential users is also at high risk of contracting sexually transmitted disease, topical methods that would provide simultaneous protection against both fertility and infection are of particular interest. This review examines the current strategies that are being pursued to achieve this objective. Language: English Keywords: AUSTRALIA | RESEARCH REPORT | FERTILITY | CONTRACEPTION | SEXUALLY TRANSMITTED DISEASES | VAGINAL BARRIER METHODS | VAGINAL SPERMICIDES | Developed Countries | Oceania | Population Dynamics | Demographic Factors | Population | Family Planning | Reproductive Tract Infections | Infections | Diseases | Barrier Methods | Contraceptive Methods Document Number: 308218 |
| 2. Peer Reviewed Title: Cervicovaginal colposcopic lesions associated with 5 nonoxynol-9 vaginal spermicide formulations. Author: Harwood B; Meyn LA; Ballagh SA; Raymond EG; Archer DF Source: American Journal of Obstetrics and Gynecology. 2008 Jan;198(1):32.e1-32.e7. Abstract: This study was undertaken to compare the colposcopic appearance of the cervicovaginal epithelium with spermicide use vs condom use in a low-risk population. This was an ancillary study of a trial comparing the efficacy of 5 nonoxynol-9 spermicides. A cohort of women who used condoms without spermicide served as a control group. Colposcopic examinations were performed during product use to identify genital lesions. One hundred fifty-one participants had 1 or more follow-up examinations. At baseline, study groups differed only by the prevalence of baseline lesions. New lesions were identified at 49% of follow-up visits. Controlling for the presence of a baseline lesion, compared with condom use none of the spermicides were associated with an increase in new lesions (overall odds ratio, 0.8; 95% CI, 0.4-1.6; P = .5); and lesions characterized by epithelial disruption were less frequent with spermicide use (overall odds ratio, 0.3; 95% CI, 0.1-0.6; P < .001). In a low-risk population, women who used nonoxynol-9 spermicides were less likely to have lesions with epithelial disruption, and equally likely to have any new lesion compared with condom use. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | COHORT ANALYSIS | SIGNS AND SYMPTOMS | WOMEN | CONDOM USE | VAGINAL SPERMICIDES | RISK FACTORS | EXPOSURE | Developed Countries | North America | Americas | Research Methodology | Diseases | Demographic Factors | Population | Risk Reduction Behavior | Behavior | Contraceptive Methods | Contraception | Family Planning | Biology Document Number: 323369 |
| 3. Peer Reviewed Title: SILCS diaphragm: Postcoital testing of a new single-size contraceptive device. Author: Schwartz JL; Ballagh SA; Creinin MD; Rountree RW; Kilbourne-Brook M Source: Contraception. 2008 Sep;78(3):237-244. Abstract: This study was conducted to compare the effectiveness of a new, single-size silicone contraceptive diaphragm used with either spermicide [2% nonoxynol-9 (N-9)] or lubricant in preventing sperm from penetrating midcycle cervical mucus. A crossover postcoital test (PCT) in healthy, sexually active women not at risk for pregnancy due to tubal occlusion was conducted. Couples had a baseline PCT without a device to verify normal fertility parameters. Qualified couples underwent up to two test cycles using the SILCS diaphragm with a metal spring. A subgroup of couples underwent a third test cycle with the SILCS polymer spring diaphragm used with N-9 gel. Fifteen couples completed a baseline cycle and were randomized to order of study gel. Of these, 14 couples completed a baseline cycle and at least one test cycle, 12 couples completed a baseline cycle and two test cycles and 8 couples completed a third test cycle with the polymer spring prototype. Sperm was detected in the vaginal pool in all completed test cycles. The SILCS metal spring diaphragms used with N-9 gel reduced the average number of progressively motile sperm per high power field in the cervical mucus from a baseline of 12.5 to 0, while use of this device with lubricant reduced the number to 0.5. The SILCS polymer spring diaphragm used with N-9 performed the same as the metal spring used with N-9. The SILCS diaphragm used with N-9 gel performed well. It is likely that the SILCS diaphragm will give acceptable results in a contraceptive effectiveness study but that adjunctive use of a chemical barrier such as N-9 gel will be necessary for it to be most effective. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL TRIALS | VAGINAL DIAPHRAGM | VAGINAL SPERMICIDES | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | North America | Americas | Clinical Research | Research Methodology | Vaginal Barrier Methods | Barrier Methods | Contraceptive Methods | Contraception | Family Planning Document Number: 327557 |
| 4. Peer Reviewed Title: Vaginal microbicide preferences among midwestern urban adolescent women. Author: Tanner AE; Katzenstein JM; Zimet GD; Cox DS; Cox AD; Fortenberry JD Source: Journal of Adolescent Health. 2008 Oct;43(4):349-56. Abstract: PURPOSE: The purpose of this study was to assess adolescent women's preferences for specific microbicide characteristics including pregnancy prevention, timing of application, potential for side effects, and whether it targeted human immunodeficiency virus (HIV) or other sexually transmitted infections (STI). Potential differences in microbicide preferences by adolescent age group and behavioral patterns including engaging in sexual intercourse and use of hormonal contraception were examined, as it was hypothesized that as adolescents progress into adulthood and gain sexual experience their preferences in microbicide characteristics may shift. METHOD: Adolescent and young women (N = 405, 56.0% African American; 24.0% Euro-American) between the ages of 14 and 20 (mean = 17.0, SD = 1.8) were recruited from urban community-based clinics. Video-Audio Computer-Assisted Self-Interviews were conducted with the young women, during which they were asked about their preferences regarding the characteristics of hypothetical vaginal microbicides. Conjoint analysis was utilized to determine adolescent women's relative preferences for each microbicide characteristic and intent-to-purchase microbicides based upon a combination of the selected properties. RESULTS: Overall, the results suggest adolescent and young women had an ordered preference for a microbicide with (1) no side effects, (2) pregnancy prevention, (3) postcoital application, and (4) protection against HIV. Age and behavioral group conjoint analyses resulted in the same pattern of preferences as those reported for the entire group. However, women having sex and not using hormonal contraception had a stronger preference for postcoital application. CONCLUSION: The findings suggest that young women's ratings of microbicides were sensitive to characteristics such as side effects, pregnancy prevention, and timing of application and should be considered in microbicide development. The conjoint analysis approach is useful in understanding microbicide preferences, and should be utilized with other populations to assess preferences for specific microbicide characteristics. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | KAP SURVEYS | URBAN POPULATION | ADOLESCENTS, FEMALE | MICROBICIDES | CONTRACEPTION | CONTRACEPTIVE AGENTS | TIME FACTORS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | SEX BEHAVIOR | COMPUTER PROGRAMS AND PROGRAMMING | AGE FACTORS | CONTRACEPTIVE AGENTS, POSTCOITAL | VAGINAL SPERMICIDES | Developed Countries | North America | Americas | Surveys | Sampling Studies | Studies | Research Methodology | Population Characteristics | Demographic Factors | Population | Adolescents | Youth | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Family Planning | Population Dynamics | Behavior | Information Processing | Information | Contraceptive Agents, Female | Contraceptive Methods Document Number: 329327 |
5.  Title: [Colombian plants with spermicidal activity, new options in anticonception: brief review] Nuevas opciones en anticoncepcion: posible uso espermicida de plantas colombianas. Author: Alvarez-Gomez AM; Cardona-Maya WD; Castro-Alvarez JF; Jimenez S; Cadavid A Source: Actas Urologicas Espanolas. 2007 Apr;31(4):372-381. Abstract: At present there is growing concern about sexual and reproductive health of adolescents, and despite the existence of different contraceptive methods the number of unwanted pregnancies is increasing. Among the products available are spermicides, which are completely controlled by the woman and have the advantage of continuous use contraception, but also have the disadvantage of causing irritation to the vaginal epithelium due to a surfactant effect on the cell membrane, which could facilitate the transmission of infections. In the search for new alternatives, we found that a wide variety of plants have spermicidal activity, which suggests an interesting proposal for a contraceptive of plant origin, which constitutes a key tool in preventing unwanted pregnancies and their impact on a particularly vulnerable population group, as are adolescent girls and young women. Language: Spanish Keywords: COLOMBIA | RESEARCH REPORT | ADOLESCENTS | PREGNANCY, UNWANTED | VAGINAL SPERMICIDES | SIDE EFFECTS | Developing Countries | South America, Northern | South America | Latin America | Americas | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Reproductive Behavior | Fertility | Population Dynamics | Contraceptive Methods | Contraception | Family Planning | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 320437 |
| 6. Peer Reviewed Title: Chenopodium album seed extract: A potent sperm-immobilizing agent both in vitro and in vivo. Author: Kumar S; Biswas S; Mandal D; Roy HN; Chakraborty S Source: Contraception. 2007 Jan;75(1):71-78. Abstract: Aqueous decoction of Chenopodium album seeds (CAD) was assessed for its sperm-immobilizing and contraceptive efficacy in laboratory mammals. Spermicidal efficacy was evaluated in vitro by a modified Sander-Cramer test. The mode of spermicidal action was assessed by (a) supravital and double fluoroprobe staining of sperm, (b) hypoosmotic swelling tests and (c) transmission electron microscopy. Contraceptive efficacy was evaluated by intrauterine and vaginal application of CAD in rats and rabbits, respectively, followed by their mating and evaluation of pregnancy outcomes. The minimum effective concentration of CAD that induced instantaneous immobilization of rat spermatozoa in vitro was 2 mg/mL. The mechanism of CAD action involved disintegration of sperm plasma membrane and dissolution of acrosomal cap causing sperm death. Fertilization of oocytes and establishment of implantation were prevented in the uterine horn that was administered with CAD, while these events occurred unhindered in the untreated contralateral side. In rabbit, intravaginal application of CAD significantly blocked the establishment of pregnancy. CAD possesses appreciable spermicidal potential, which may be explored as an effector constituent of vaginal contraceptive. (author's) Language: English Keywords: INDIA | RESEARCH REPORT | CONTRACEPTION RESEARCH | LABORATORY ANIMALS | SPERM IMMOBILIZING AGENTS | CONTRACEPTIVE EFFECTIVENESS | MEDICINAL PLANTS | SPERMICIDAL CONTRACEPTIVE AGENTS | VAGINAL SPERMICIDES | Asia, Southern | Asia | Developing Countries | Contraception | Family Planning | Clinical Research | Research Methodology | Contraceptive Agents | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods Document Number: 310442 |
| 7. Peer Reviewed Title: Desired qualities and hypothetical contextual use of vaginal microbicides in a diverse sample of US women. Author: Olsen ML; Cwiak CA; Koudelka C; Jensen JT Source: Contraception. 2007 Oct;76(4):314-318. Abstract: Vaginal microbicides represent an important emerging class of antiinfectives. To guide research and development, we conducted a survey to determine interest in desired qualities of and intended use of microbicides within the current milieu of contraceptive options. Women completed an anonymous survey while waiting for health care clinic appointments in Portland, OR, and Atlanta, GA, and in one public area (Atlanta). Four hundred one women completed the survey. Subjects had a mean age of 25.6 (SD=7.4), parity of 1.5 (SD=1.6) and 47.7% were non-Caucasian. Respondents showed moderate interest in noncontraceptive anti-HIV gel-based microbicides (mean, 53.8; SD, 39.6; n=362) and significantly stronger interest in contraceptive anti-HIV microbicides (mean, 89.4 mm; SD, 20.7; n=363; p < .001). The qualities of HIV, pregnancy and sexually transmitted infection (STI) prevention were the highest priorities of the largest percentage (40%) of respondents. Half (49.6%) of respondents reported they would use another form of protection in conjunction with a contraceptive anti-HIV microbicide. A diverse sample of women reported substantial interest in vaginal microbicides capable of preventing HIV and pregnancy, and a smaller high-risk subgroup was interested in noncontraceptive anti-HIV microbicides. Most women would prefer a product capable of preventing HIV, pregnancy and STIs. Almost half of respondents would use vaginal microbicides as part of a dual method. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | SURVEYS | WOMEN | MICROBICIDES | VAGINAL SPERMICIDES | CONTRACEPTIVE METHOD ACCEPTABILITY | CONTRACEPTION | HIV INFECTIONS | SEXUALLY TRANSMITTED DISEASES | Developed Countries | North America | Americas | Sampling Studies | Studies | Research Methodology | Demographic Factors | Population | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods | Family Planning | Contraceptive Usage | Viral Diseases | Diseases | Reproductive Tract Infections | Infections Document Number: 320551 |
| 8. Peer Reviewed Title: Pregnancy in effectiveness trials of HIV prevention agents. Author: Raymond EG; Taylor D; Cates W Jr; Tolley EE; Borasky D Source: Sexually Transmitted Diseases. 2007 Dec;34(12):1035-1039 . Abstract: Despite remarkable progress over the past several decades in understanding the biology and epidemiology of the HIV pandemic, the virus continues to spread relentlessly. Diverse prevention approaches are desperately needed to reverse this trend. For many women, products that can be used without the cooperation of male partners are critical. Multiple such products are currently being tested in large-scale effectiveness trials, and many more are in earlier stages of development. These products include physical and chemical barriers to viral entry, vaginal pH buffers, an antiherpes drug, antiretroviral drugs, and other agents. Some of these products may have contraceptive as well as anti-infective activity. The basic design of HIV prevention trials is standard: HIV-negative women at risk for HIV infection are randomly assigned to use either the study product or a placebo according to a specified schedule (e.g., daily or before each coital act) and then are followed to assess HIV incidence. Most HIV prevention trials are conducted in resource-poor settings in Africa and Asia where HIV incidence is high. (excerpt) Language: English Keywords: UNITED STATES OF AMERICA | NORTH CAROLINA | RESEARCH REPORT | CLINICAL TRIALS | PREGNANT WOMEN | PREGNANCY | HIV PREVENTION | DRUGS | SAFETY | VAGINAL SPERMICIDES | MICROBICIDES | ANTIVIRAL DRUGS | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | North America | Americas | Clinical Research | Research Methodology | Population Characteristics | Demographic Factors | Population | Reproduction | HIV Infections | Viral Diseases | Diseases | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Public Health | Contraceptive Methods | Contraception | Family Planning Document Number: 322525 |
| 9. Title: Vaginal microbicides. Author: O'Brien RF Source: Adolescent Medicine Clinics. 2006 Oct;17(3):673-685. Abstract: The vulnerability of women to HIV and other STIs has led to interest in female-controlled preventive measures, with vaginal microbicides applied as a cream, foam, or gel to reduce acquisition of infection. As microbicides are developed, it is important to assess whether microbicidal activity against concomitant genital infections would give additional protection against HIV. This article reviews the current status of microbicide development and challenges faced in developing safe and effective compounds. Experience with nonoxynol-9 should lead to a cautious approach. This spermicide initially was believed to be promising as a microbicide because it disrupts cell membranes and has in vitro activity against bacteria and the HIV envelope. Despite in vitro effectiveness, nonoxynol-9 failed to protect against HIV, however, and with frequent use was found to cause inflammation in the female genital tract and increased susceptibility to HIV infection. Careful monitoring for safety is imperative in microbicide research. (excerpt) Language: English Keywords: UNITED STATES OF AMERICA | LITERATURE REVIEW | WOMEN | HIV PREVENTION | MICROBICIDES | VAGINAL SPERMICIDES | VAGINAL CREAM | VAGINAL FOAM | VAGINAL GEL | ADMINISTRATION AND DOSAGE | SAFETY | North America | Americas | Developed Countries | Demographic Factors | Population | HIV Infections | Viral Diseases | Diseases | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods | Contraception | Family Planning | Public Health Document Number: 311667 |
| 10. Peer Reviewed Title: A human colorectal explant culture to evaluate topical microbicides for the prevention of HIV infection. Author: Abner SR; Guenthner PC; Guarner J; Hancock KA; Cummins JE Jr Source: Journal of Infectious Diseases. 2005;192:1545-1556. Abstract: A human colorectal explant culture was developed to assess the safety and efficacy of topical microbicides proposed for use in humans. Because any product marketed for vaginal application will likely be used for anal intercourse, it is important to evaluate these products in colorectal explant tissue. Microbicides tested included cellulose acetate 1,2-benzenedicarboxylate (CAP), PRO 2000, SPL7013, Vena Gel, and UC781, along with their accompanying placebos. Colorectal tissues were exposed to microbicides overnight and either fixed in formalin to evaluate toxicity by histological analysis or placed in 1-(4,5-dimethylthiazol-2-yl)-3,5-diphenylformazan (MTT) to quantitatively determine tissue viability. Histological analysis showed minimal toxicity for CAP, UC781, and Vena Gel. Shedding of epithelium with intact lamina propria occurred for the PRO 2000 and SPL7013 products, and shedding of epithelium and necrosis of the lamina propria occurred in explants cultured with nonoxynol-9. The MTT assay confirmed these results for PRO 2000 (4% and 0.5%), SPL7013 (and placebo), and nonoxynol-9 but also demonstrated reduced viability for CAP. However, viability of tissues treated with all products was not significantly different from that of the medium control. Efficacy of the microbicides was evaluated by measuring human immunodeficiency virus type 1 (HIV-1) infection of explants in the absence or presence of products. All microbicide formulations tested were highly effective in preventing HIV infection. However, explants treated with some of the placebo formulations also exhibited a lower level of infection. Most of the products developed for vaginal application showed minimal toxicity and were effective in reducing HIV-1 infection in colorectal tissues. These results suggest that this model is useful for evaluating the safety and efficacy of topical microbicides when used rectally. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | RESEARCH ACTIVITIES | ANAL SEX | MICROBICIDES | HIV PREVENTION | VAGINAL SPERMICIDES | North America | Americas | Developed Countries | Research Methodology | Sex Behavior | Behavior | Drugs | Treatment | HIV Infections | Viral Diseases | Diseases | Contraceptive Methods | Contraception | Family Planning Document Number: 290952 |
| 11. Title: Preferences and practices related to vaginal lubrication: implications for microbicide acceptability and clinical testing. Author: Braunstein S; van de Wijgert J Source: Journal of Women's Health. 2005;14(5):424-433. Abstract: Research on vaginal microbicides for HIV prevention is progressing rapidly; the first large-scale effectiveness trials were launched in 2004. The majority of candidate microbicides are formulated as gels, which will act as lubricants when used during sex. Preferences and practices regarding lubrication during sex, therefore, likely influence microbicide acceptability and use. Researchers seek to maximize consistent and correct use of candidate microbicides during clinical trials to enable valid estimates of product effectiveness, and if proven effective, microbicides will be widely used only if acceptable. We conducted a comprehensive literature review and interviewed 13 key informants from nine countries in Africa, Asia, Latin America, and North America. We found that norms and practices regarding lubrication during sex exist in many different countries. Despite significant variation, common themes emerged. In the majority of countries, women’s genital hygiene is highly valued, and women are expected to achieve a moderate amount of vaginal lubrication during sex that is neither excessive nor inadequate. Women may try to achieve this by engaging in a wide variety of vaginal practices. Even though some informants expressed concerns about the acceptability of lubricating microbicides in some settings, they thought that microbicides should be developed, that women and men may be willing to accept a certain level of increased lubrication in exchange for protection from HIV, and that lubricating microbicides may be considered more acceptable when perceived as genital hygiene products. Recommendations are made on how to take vaginal practices into account during clinical testing of microbicides. (author's) Language: English Keywords: GLOBAL | LITERATURE REVIEW | CLINICAL TRIALS | INTERVIEWS | LUBRICANTS | MICROBICIDES | CONTRACEPTIVE METHOD ACCEPTABILITY | HIV PREVENTION | HYGIENE | SEX BEHAVIOR | VAGINAL SPERMICIDES | CULTURE | Clinical Research | Research Methodology | Data Collection | Ingredients and Chemicals | Drugs | Treatment | Contraceptive Usage | Contraception | Family Planning | HIV Infections | Viral Diseases | Diseases | Public Health | Health | Behavior | Contraceptive Methods Document Number: 289317 |
| 12. Title: Spermicide used alone for contraception (Review). Author: Grimes DA; Lopez L; Raymond EG; Halpern V; Nanda K Source: Cochrane Database of Systematic Reviews. 2005 Oct 19;(4):[26] p.. ID: CD005218 Abstract: Spermicides have been used as contraceptives for thousands of years. Despite this long use, only recently have studies examined the comparative efficacy and acceptability of these vaginal medications. Spermicides contain an active ingredient (most commonly nonoxynol-9) and a formulation used to disperse the product, such as foam or vaginal suppository. This review examined all known randomized controlled trials of a spermicide used alone for contraception. We searched the following computerized databases from inception to July 2004 for randomized controlled trials of spermicides for contraception: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, POPLINE, LILACS, and EMBASE. We examined the reference list of each trial found as well as that of review articles and textbook chapters. We included any trial of a commercial product used alone for contraception. Each included trial must have provided sufficient information to determine pregnancy rates. We located reports from 14 trials. Two reviewers independently extracted information from the trials identified. We did not conduct a meta-analysis, since most trials had large losses to follow-up. We entered the data into tables and presented the results descriptively. In the largest trial to date, the gel (Advantage S) containing the lowest dose of nonoxynol-9 (52.5 mg) was significantly less effective in preventing pregnancy than were gels with higher doses of the same agent (100 mg and 150 mg). Probabilities of pregnancy by six months were 22% for the 52.5 mg gel, 16% for the 100 mg dose, and 14% for the 150 mg dose. In the same trial, the three different vehicles with 100 mg of nonoxynol-9 had similar efficacy. Interpretation of these figures is limited, since 39% of participants discontinued the method or were lost from the trial. Few important differences in efficacy emerged in other trials. The probability of pregnancy varied widely in reported trials. A gel containing nonoxynol-9 52.5 mg was inferior to two other products tested in the largest trial. Aside from this finding, personal characteristics and behavior of users may be more important than characteristics of the spermicide products in determining the probability of pregnancy. Gel was liked more than the film or vaginal suppository in the largest trial. Spermicide trials have the dual challenges of difficult recruitment and high discontinuation rates; the latter threatens trial validity. (author's) Language: English Keywords: GLOBAL | LITERATURE REVIEW | DATA ANALYSIS | WOMEN | VAGINAL SPERMICIDES | CONTRACEPTIVE USAGE | FERTILITY RATE | CONTRACEPTION FAILURE | Research Methodology | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Birth Rate | Fertility Measurements | Fertility | Population Dynamics Document Number: 307781 |
| 13. Peer Reviewed Title: Acceptability of five nonoxynol-9 spermicides. Author: Raymond EG; Chen PL; Condon S; Luoto J; Barnhart KT Source: Contraception. 2005;71:438-442. Abstract: The objective was to examine the acceptability of five nonoxynol-9 (N-9) spermicides. We analyzed data from a randomized trial of five products, including three gels containing different amounts of N-9 per dose, a film and a suppository. In the trial, 1536 participants were asked to use the assigned spermicide for 7 months and to complete questionnaires 4 weeks after admission and at discontinuation. Overall, 43% of participants liked their spermicide “very much.” This proportion was higher in the three gel groups than in the suppository and film groups. Difficulty with insertion, messiness and discontent with timing of insertion were common complaints in all groups. After adjustment for selected baseline factors, acceptability on the first questionnaire was not related to duration or consistency of subsequent spermicide use or to subsequent time to pregnancy. In this study, all five spermicides were considered acceptable by most users. Acceptability did not appear to influence spermicide use or pregnancy risk. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | KAP SURVEYS | CLINICAL TRIALS | WOMEN | NONOXYNOL-9 | VAGINAL SPERMICIDES | TIME FACTORS | SATISFACTION | CONTRACEPTIVE USAGE | PREGNANCY RATE | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | North America | Americas | Surveys | Sampling Studies | Studies | Research Methodology | Clinical Research | Demographic Factors | Population | Spermicidal Contraceptive Agents | Contraceptive Agents | Contraception | Family Planning | Contraceptive Methods | Population Dynamics | Psychological Factors | Behavior | Fertility Measurements | Fertility Document Number: 286725 |
| 14. Title: Sophorolipids, microbial glycolipids with anti-human immunodeficiency virus and sperm-immobilizing activities. Author: Shah V; Doncel GF; Seyoum T; Eaton KM; Zalenskaya I Source: Antimicrobial Agents and Chemotherapy. 2005 Oct;49(10):4093-4100. Abstract: The increased incidence of human immunodeficiency virus (HIV)/AIDS disease in women aged 15 to 49 years has identified the urgent need for a female-controlled, efficacious, and safe vaginal topical microbicide. To meet this challenge, sophorolipid (SL) produced by Candida bombicola and its structural analogs have been studied in this report for their spermicidal, anti-HIV, and cytotoxic activities. The sophorolipid diacetate ethyl ester derivative is the most potent spermicidal and virucidal agent of the series of SLs studied. Its virucidal activity against HIV and sperm-immobilizing activity against human semen are similar to those of nonoxynol-9. However, it also induced enough vaginal cell toxicity to raise concerns about its applicability for long-term microbicidal contraception. Its structure-activity relationship has been established for creating new analogs with less cytotoxicity and higher activity. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | WOMEN | HIV PREVENTION | VAGINAL SPERMICIDES | MICROBICIDES | SAFETY | VAGINA | CYTOLOGY | TOXICITY | LONGTERM EFFECTS | CONTRACEPTION | North America | Americas | Developed Countries | Demographic Factors | Population | HIV Infections | Viral Diseases | Diseases | Contraceptive Methods | Family Planning | Drugs | Treatment | Public Health | Health | Genitalia, Female | Genitalia | Urogenital System | Physiology | Biology | Time Factors | Population Dynamics Document Number: 284824 |
| 15. Peer Reviewed Title: Contraception by Ushercell (cellulose sulfate) in formulation: duration of effect and dose effectiveness. Author: Anderson RA; Feathergill K; Diao X; Chany C 2d; Rencher WF Source: Contraception. 2004;70:415-422. Abstract: This study evaluated contraception by formulated Ushercell(tm), a uniquely high-molecular-weight form of cellulose sulfate, in the rabbit. Variables included (1) dose effectiveness, (2) duration of effectiveness, and (3) formulation excipients. Vaginally applied carboxymethyl-cellulose-based Ushercell(tm) gel is contraceptive. A 6% gel is active for at least 18 h; partial activity is observed for at least 24 h. With an application-insemination interval of 0.5 h, Ushercell(tm) as low as 0.1% is contraceptive. Contraception is incomplete with 2% Ushercell(tm) and an application-insemination interval of 24 h. Ushercell(tm) formulations containing a relatively high concentration of Carbopol are ineffective contraceptives, whether the gel is applied before insemination or is premixed with spermatozoa before insemination. Contraceptive activity is restored in Ushercell(tm) formulations with lower Carbopol content. This study shows that formulated Ushercell(tm) is an effective, long-lasting contraceptive and, hence, is bioavailable when vaginally applied. Activity is dependent on the type and relative concentration of formulation excipients. These data support a projected successful outcome of further clinical trials. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | RESEARCH ACTIVITIES | LABORATORY ANIMALS | SPERMICIDAL CONTRACEPTIVE AGENTS | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE SAFETY | MICROBICIDES | VAGINAL GEL | VAGINAL SPERMICIDES | Developed Countries | North America | Americas | Research Methodology | Clinical Research | Contraceptive Agents | Contraception | Family Planning | Safety | Public Health | Health | Drugs | Treatment | Contraceptive Methods Document Number: 276171 |
| 16. Title: Clinical development of microbicides for the prevention of HIV infection. Author: D'Cruz OJ; Uckun FM Source: Current Pharmaceutical Design. 2004;10(3):315-336. Abstract: The HIV/AIDS pandemic continues its spread at a rate of over 15,000 new infections every day. Sexual transmission of HIV-1 is the dominant mode of this pandemic spread. For the first time since the disease emerged in the early 1980s, about half the 42 million people now living with HIV/AIDS worldwide are women. Worldwide, more than 90 percent of all adolescent and adult HIV infections have resulted from heterosexual intercourse. The "feminization" of the pandemic largely driven by the social, economic, and biological factors warrants urgent attention particularly for the adolescent female population. In the absence of an effective prophylactic anti-HIV therapy or vaccine, current efforts are aimed at developing intravaginal/intrarectal topical formulations of anti-HIV agents or microbicides to curb the mucosal and perinatal HIV transmission. Microbicides would provide protection by directly inactivating HIV or preventing HIV from attaching, entering or replicating in susceptible target cells as well as dissemination from target cells present in semen or the host cells that line the vaginal/rectal wall. Thus, ideally, anti-HIV microbicides should be capable of attacking HIV from different angles. In addition, a contraceptive microbicide could help prevent unintended pregnancies worldwide. To be a microbicide, these agents must be safe, effective following vaginal or rectal administration, and should cause minimal or no genital symptoms following long-term repeated usage. A safe and efficacious anti-HIV microbicide is not yet available despite the fact that more than 60 candidate agents have been identified to have in vitro activity against HIV, 18 of which have advanced to clinical testing. Targeting HIV entry has been a favored approach because it is the first step in the process of infection and several readily available anionic polymeric products seem to variably interfere with these processes are the primary candidates for potential microbicides. Formulations of some anionic polymeric antiviral agents have been tested at various doses and various durations for safety, tolerability, and acceptability in Phase I/II clinical trials (vaginal, rectal, or penile studies) in HIV-uninfected and/or HIV- infected populations. Current multicenter Phase I/II safety and Phase II/III efficacy studies that are being conducted or planned in different geographical locations by various special interest groups are designed for rapid clinical development of candidate products. The currently marketed detergent-type spermicide, nonoxynol-9 (N-9), has failed in Phase III clinical trials, due to the drug-induced formation of localized genital lesions that might in fact actually promote virus transmission. Alternative "first-generation" microbicides that have undergone Phase I/II safety and tolerability studies in HIV-uninfected and/or HIV-infected volunteers include polymeric viral fusion inhibitors (dextrin sulfate/Emmelle™, carrageenans [PC-213, PC-503, PC-515/Carraguard™], cellulose sulfate/Ushercell™, polystyrene sulfonate, naphthalene sulfonate [PIC 024-4/PRO 2000/5], acidifying gel [Carbomer 974P/BufferGel™], Lactobacillus (L. crispatus) suppository/CTV-05, detergent-type dual-function barriers [ACIDFORM™, GEDA Plus™, SURETE™, Glyminox™/C31G/Savvy™, Invisible Condom], herbal extracts [Praneem™], and viral replication inhibitors [PMPA/Tenofovir™]. For majority of these products, no information is available regarding their long-term mucosal safety, carcinogenicity potential, bioavailability, or efficacy following their extended vaginal or rectal exposure. The irritative genitourinary symptoms reported for a number of these first-generation products in Phase I clinical trials implies that the "soft" preclinical endpoints for mucosal safety established for the use and development of vaginal spermicides may not be rigorous enough for vaginal and rectal microbicides because of the efficient sexual transmission of virus, virus diversity, and genetic environment. It is now apparent that sexually transmitted R5 HIV-1 viruses have less positive charge on their surface compared with the R4 HIV-1 viruses, which may limit the anionic polymers as topical microbicides despite extensive clinical trials. Nevertheless, their ongoing clinical trials, reviewed here, using optimized formulations, and special populations in various geographic locations are paving the way for future rigorous clinical testing of "mechanism-based" broad-spectrum anti-HIV microbicides that are currently under intense development. It is anticipated that future microbicide trials will focus on combination of products capable of attacking HIV life cycle at multiple steps intended to increase efficacy, limit cross-resistance as well as minimize microbicide-induced host toxicity. (author's) Language: English Keywords: UNITED STATES OF AMERICA | GLOBAL | RESEARCH REPORT | CLINICAL TRIALS | HIV INFECTIONS | SEXUALLY TRANSMITTED DISEASES | AIDS | MICROBICIDES | VAGINAL SPERMICIDES | SAFETY | Developed Countries | North America | Americas | Clinical Research | Research Methodology | Viral Diseases | Diseases | Reproductive Tract Infections | Infections | Drugs | Treatment | Contraceptive Methods | Contraception | Family Planning | Public Health | Health Document Number: 277829 |
| 17. Peer Reviewed Title: Single and multiple exposure tolerance study of polystyrene sulfonate gel: a Phase I safety and colposcopy study. Author: Mauck CK; Weiner DH; Ballagh SA; Creinin MD; Archer DF Source: Contraception. 2004 Jul;70(1):77-83. Abstract: Objectives: To evaluate symptoms and signs of genital irritation, vaginal leakage and acceptability of polystyrene sulfonate (PSS), which is being studied as a vaginal contraceptive and microbicide. Methods: Forty-nine women applied 2.5 mL of either 5% PSS, 10% PSS, PSS vehicle, or Conceptrol (a marketed spermicidal product containing 4% nonoxynol-9) for 6 consecutive days. Results: All women completed the study except one in the Conceptrol group who experienced vaginal symptoms after her first use and was discontinued. After both the first use and after all uses, irritation was seen among more women in the Conceptrol group than in the PSS groups, reaching statistical significance with regard to any evidence of irritation, signs of irritation and product-related irritation. There were no adverse events that were serious, unexpected and related to product use in any group. The 5% concentration of PSS may be preferable in terms of leakage and acceptability. Conclusion: The results suggest that PSS has a safety profile comparable to that of the marketed nonoxynol-9 product, Conceptrol, and appears to be associated with less genital irritation. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL TRIALS | WOMEN | SIGNS AND SYMPTOMS | GENITAL EFFECTS, FEMALE | DRUGS | INFECTION PREVENTION | VAGINAL APPROACH | MICROBICIDES | CONTRACEPTION | VAGINAL SPERMICIDES | Developed Countries | North America | Americas | Clinical Research | Research Methodology | Demographic Factors | Population | Diseases | Genitalia, Female | Genitalia | Urogenital System | Physiology | Biology | Treatment | Infections | Female Sterilization | Sterilization, Sexual | Family Planning | Contraceptive Methods Document Number: 194563 |
| 18. Title: Diaphragm versus diaphragm with spermicides for contraception. Author: Cook L; Nanda K; Grimes D Source: Cochrane Database of Systematic Reviews. 2003 Jan;(1):[9] p.. Art. No.: CD002031 Abstract: The diaphragm is usually used with a spermicide. However, some practitioners have suggested that spermicides offer no additional contraceptive protection and have advocated alternative guidelines for the use of diaphragms. The objective of this review was to compare the effectiveness, safety and acceptability of the diaphragm with and without spermicide. We searched MEDLINE, EMBASE, POPLINE, CINAHL, the Cochrane Controlled Trials Register, and reference lists of relevant articles. In addition, we contacted experts in the field to identify unpublished studies. Randomized controlled trials comparing women of reproductive age using the diaphragm with and without spermicide as the sole contraceptive method that reported clinical outcomes. Two reviewers independently extracted data on outcomes and trial characteristics and any discrepancies were resolved by consensus or by consultation with the third reviewer. The results of the one identified study are presented descriptively. We identified only one study. No significant difference was found in the pregnancy rates (with typical use or consistent use) or discontinuation rates between the diaphragm-with-spermicide and diaphragm-without spermicide groups. There was a trend towards higher pregnancy rates in the diaphragm-without-spermicide group. However, this study failed to recruit the planned number of participants and was consequently underpowered. As only one underpowered study was identified, we cannot distinguish between the contraceptive effectiveness of the diaphragm with and without spermicide. We cannot draw any conclusion at this point, further research is needed. However, the study provides no evidence to change the commonly recommended practice of using the diaphragm with spermicide. (author's) Language: English Keywords: UNITED STATES OF AMERICA | CONTROL GROUPS | WOMEN | VAGINAL DIAPHRAGM | VAGINAL SPERMICIDES | SAFETY | CONTRACEPTIVE USE-EFFECTIVENESS | PROGRAM ACCEPTABILITY | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Vaginal Barrier Methods | Barrier Methods | Contraceptive Methods | Contraception | Family Planning | Public Health | Health | Contraceptive Effectiveness | Program Evaluation | Programs | Organization and Administration Document Number: 195628 |
| 19. Peer Reviewed Title: Disruption of the upper female reproductive tract epithelium by nonoxynol-9. Author: Dayal MB; Wheeler J; Williams CJ; Barnhart KT Source: Contraception. 2003 Oct;68(4):273-279. Abstract: Background: Spermicides containing nonoxynol-9 (N-9) may increase HIV transmission. In women, intravaginal N-9 is found in the uterus shortly after its insertion. Exposure of the female upper reproductive tract to N-9 may alter epithelial integrity, thereby increasing HIV transmission risk. Our goal was to characterize the histological effects of N-9 on uterine epithelium in an animal model. Methods: Female mice were exposed to intravaginal or intrauterine Advantage-S (N-9), Replens, K-Y jelly or water. After various exposure times, mice were sacrificed and stained uterine tissue sections were analyzed by a pathologist blinded to treatment. Results: Intravaginal and intrauterine N-9 administration resulted in disruption of uterine epithelium compared to Replens, K-Y jelly or water. N-9 caused rapid (within 10 min), focal, uterine epithelial sloughing and complete epithelial loss within 24 h. Epithelial regeneration began 48 h after exposure N-9 and was completely restored within 72 h; the new epithelial layer, however, was composed of cuboidal cells instead of normally present columnar cells. In addition, hemorrhage and necrosis were present are all time points examined. Conclusions: Our results demonstrate for the first time that N-9 has a deleterious effect on uterine epithelium. Although these results were observed in a mouse model, similar disruption of the upper reproductive tract epithelium in women by N-9 may facilitate HIV infection and serve as an unrecognized portal of human HIV transmission. (author's) Language: English Keywords: PENNSYLVANIA | RESEARCH REPORT | EXPERIMENTAL MODELS | DOUBLE-BLIND STUDIES | LABORATORY ANIMALS | WOMEN | PERSONS LIVING WITH HIV/AIDS | SPERMICIDAL CONTRACEPTIVE AGENTS | HIV INFECTIONS | UTERINE EFFECTS | HISTOCHEMICAL EFFECTS | VAGINAL SPERMICIDES | VAGINAL GEL | LABORATORY EXAMINATIONS AND DIAGNOSES | TIME FACTORS | METRORRHAGIA | CONTRACEPTION RESEARCH | CONTRACEPTIVE SAFETY | Developed Countries | United States of America | North America | Americas | Research Methodology | Studies | Clinical Research | Demographic Factors | Population | Viral Diseases | Diseases | Contraceptive Agents | Contraception | Family Planning | Uterus | Genitalia, Female | Genitalia | Urogenital System | Physiology | Biology | Cytologic Effects | Contraceptive Methods | Examinations and Diagnoses | Population Dynamics | Bleeding | Signs and Symptoms | Safety | Public Health | Health Document Number: 188377 |
| 20. Peer Reviewed Title: Thermoreversible gel formulation containing sodium lauryl sulfate as a potential contraceptive device. Author: Haineault C; Gourde P; Perron S; Desormeaux A; Piret J Source: Biology of Reproduction. 2003;69:687-694. Abstract: The contraceptive properties of a gel formulation containing sodium lauryl sulfate were investigated in both in vitro and in vivo models. Results showed that sodium lauryl sulfate inhibited, in a concentration-dependent manner, the activity of sheep testicular hyaluronidase. Sodium lauryl sulfate also completely inhibited human sperm motility as evaluated by the 30-sec Sander- Cramer test. The acid-buffering capacity of gel formulations containing sodium lauryl sulfate increased with the molarity of the citrate buffers used for their preparations. Furthermore, experiments in which semen was mixed with undiluted gel formulations in different proportions confirmed their physiologically relevant buffering capacity. Intravaginal application of the gel formulation containing sodium lauryl sulfate to rabbits before their artificial insemination with freshly ejaculated semen completely prevented egg fertilization. The gel formulation containing sodium lauryl sulfate was fully compatible with nonlubricated latex condoms. Taken together, these results suggest that the gel formulation containing sodium lauryl sulfate could represent a potential candidate for use as a topical vaginal spermicidal formulation to provide fertility control in women. (author's) Language: English Keywords: CANADA | RESEARCH REPORT | CONTRACEPTIVE AGENTS, FEMALE | SPERMICIDAL CONTRACEPTIVE AGENTS | INGREDIENTS AND CHEMICALS | VAGINAL SPERMICIDES | VAGINAL GEL | CONDOMS | CONTRACEPTION RESEARCH | WOMEN | North America, Northern | Americas | Developed Countries | Contraceptive Agents | Contraception | Family Planning | Contraceptive Methods | Barrier Methods | Demographic Factors | Population Document Number: 182446 |
| 21. Peer Reviewed Title: Spermicidal activity of Azadirachta indica (neem) leaf extract. Author: Khillare B; Shrivastav TG Source: Contraception. 2003 Sep;68(3):225-229. Abstract: The present study was carried out to evaluate the effective concentration of aqueous extract of old and tender Azadirachta indica (neem) leaves to immobilize and kill 100% human spermatozoa within 20 s. Sander–Cramer test was used to study the spermicidal activity of neem leaf extract. Under the test conditions, minimum effective spermicidal concentrations for tender and old leaf extracts were 2.91 ± 0.669 mg/million sperm and 2.75 ± 0.754 mg/million sperm, respectively. The effect of extracts on morphology and viability of sperm was also studied and no change was observed in morphology of head, mid-piece and tail and no viable sperm seen. The leaf extracts were found to be water soluble and carbohydrate in nature. The effect of different concentrations of extracts (old and tender) on percentage motility of the sperm was also studied. With an increase in concentration, there is a linear decrease in percentage motility, becoming zero at a 3-mg dose within 20 s. (author's) Language: English Keywords: ASIA | INDIA | RESEARCH REPORT | RESEARCH ACTIVITIES | HEALTH PERSONNEL | SPERMICIDAL CONTRACEPTIVE AGENTS | CONTRACEPTION RESEARCH | TRADITIONAL MEDICINE | MEDICINAL PLANTS | VAGINAL SPERMICIDES | Developing Countries | Asia, Southern | Research Methodology | Delivery of Health Care | Health | Contraceptive Agents | Contraception | Family Planning | Medicine | Health Services | Contraceptive Methods Document Number: 188241 |
| 22. Peer Reviewed Title: Effect of spermicides on Lactobacillus acidophilus in vitro- nonoxynol-9 vs. sapindus saponins. Author: Ojha P; Maikhuri JP; Gupta G Source: Contraception. 2003 Aug;68(2):135-138. Abstract: Saponins extracted from the fruit pericarp of Sapindus mukorosii were tested for their bactericidal/bacteriostatic property against Lactobacillus acidophilus. Nonoxynol-9 was used as a reference compound for the comparison of activity. Lactobacillus colonies were grown on specific medium (Rogosa SL agar) containing different concentrations of saponins and nonoxynol-9 in an atmosphere of 5% CO2/95% air at 37°C for 72 h. The number and size of colonies were recorded at the end of the experiment and compared with controls. Results indicated that nearly 90% of Lactobacillus colonies with minor reduction in size thrived at 0.05% concentration of saponins whereas only 18% of colonies with ~75% reduction in size grew in dishes containing 0.05% nonoxynol-9. At higher concentrations of saponins, there was a gradual, dose-dependent reduction in the number and size of colonies and at 2.5% concentration there was an approximately 55% reduction in the number and 60% reduction in the size of surviving colonies. No lactobacillus colonies, however, grew in dishes containing 0.1% and higher concentrations of nonoxynol-9. The studies indicate that Sapindus saponins as compared to nonoxynol-9 are far less toxic to lactobacillus species and therefore saponins containing spermicidal preparations are likely to be more vaginal-friendly than equivalent nonoxynol-9 preparations. (author's) Language: English Keywords: INDIA | RESEARCH REPORT | SPERMICIDAL CONTRACEPTIVE AGENTS | NONOXYNOL-9 | CONTRACEPTION RESEARCH | MICROBICIDES | IN VITRO | VAGINAL SPERMICIDES | SIDE EFFECTS | Asia, Southern | Asia | Developing Countries | Contraceptive Agents | Contraception | Family Planning | Drugs | Treatment | Clinical Research | Research Methodology | Contraceptive Methods Document Number: 184631 |
| 23. Peer Reviewed Title: Curcumin: a potential vaginal contraceptive. Author: Rithaporn T; Monga M; Rajasekaran M Source: Contraception. 2003 Sep;68(3):219-223. Abstract: The purpose of this investigation was to evaluate the sperm-immobilizing effects of curcumin, a plant-derived diferuloylmethane compound. Washed human healthy sperm were suspended in Ham’s F10 and exposed to varying concentrations of curcumin. Sperm motility was evaluated and changes in sperm mitochondrial transmembrane potential (MTP) was quantified by flow cytometry. Incubation of normal human sperm with curcumin resulted in a dose- and time-dependent loss of sperm motility. At lower concentrations (30 g/mL), curcumin produced a significant (20%) decrease in sperm motility within 30 min without significant effects on sperm viability. An instantaneous (_50%) loss of sperm motility was observed with higher concentrations (300 g/mL) of curcumin and a total loss of sperm motility was achieved within 60 min. A significant reduction in sperm MTP was found with all doses of curcumin tested. Our results indicate that curcumin has a selective sperm-immobilizing effect, in addition to a previously studied anti-HIV property. This compound may have potential clinical applications as a novel intravaginal spermicidal agent for contraception and HIV prevention. (author's) Language: English Keywords: UNITED STATES OF AMERICA | CALIFORNIA | RESEARCH REPORT | RESEARCH ACTIVITIES | WOMEN | SPERMICIDAL CONTRACEPTIVE AGENTS | VAGINAL SPERMICIDES | SPERM IMMOBILIZING AGENTS | HIV PREVENTION | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Contraceptive Agents | Contraception | Family Planning | Contraceptive Methods | HIV Infections | Viral Diseases | Diseases Document Number: 188240 |
| 24. Title: Evaluating factors associated with STD infection in a study with interval-censored event times and an unknown proportion of participants not at risk for disease. [Evaluation des facteurs associés à l'infection par des MST (Maladies Sexuellement Transmissibles) dans le cadre d'une étude avec des périodes d'événements à intervalles tronqués et une proportion inconnue de participants non à risque en ce qui concerne la maladie] Author: Taylor DJ; Weaver MA; Roddy RE Source: Statistics in Medicine. 2003;22(13):2191-2204. Abstract: Sexually transmitted diseases (STD) are a major cause of morbidity and mortality world-wide. Because of their association with an increased risk of infection with human immunodeficiency virus, the prevention and control of STD are particularly important. Studies designed to evaluate factors associated with the transmission of STD can pose a number of statistical challenges, however. Two such concerns are the interval-censored event times that result from spacing between follow-up test visits, and an unknown proportion of study participants who are not at risk for infection. Researchers in various fields of study have used parametric mixture models to account for individuals not at risk. Owing to non-identifiability concerns within the mixture model framework, however, it is not always possible to distinguish between effects of explanatory variables on the distribution of event times for at-risk individuals and their effects on the probability of being at risk. We address these issues using data from a clinical trial designed to investigate the effectiveness of an intravaginal microbicide in preventing male-to-female transmission of STD. Factors associated with time to infection among at-risk women are initially identified by fitting right-truncated models to the interval-censored event times of participants who tested positive for STD, and hence are known to have been at risk. Subsequently, factors associated with the probability of being at risk are evaluated using mixture models that incorporate information contributed by the right-censored event-free times of uninfected study participants. (author's) French Abstract: Les maladies transmises sexuellement (MTS) sont une cause majeure de morbidité et de mortalité dans le monde. Celles-ci étant liées à une augmentation du risque d'infection par le virus de l'immunodéficience humaine, il est particulièrement important d'en faire la prévention et le contrôle. Toutefois, les études visant à évaluer les facteurs liés à la transmission des MTS peuvent constituer de multiples gageures pour les statisticiens. Deux problèmes se posent en particulier : primo, la durée de survenue d'un événement ne peut être observée que de manière incomplète du fait d'intervalles entre les visites de suivi, ce qui produit des données censurées et, secundo, il existe pour toute étude une proportion inconnue de participants qui ne présentent pas de risque d'infection par le VIH. Des chercheurs spécialisés dans divers domaines d'étude ont eu recours à la méthode d'estimation paramétrique multi-modèle pour tenir compte de ces individus considrés comme non à risque. Mais du fait des problèmes de non-identifiabilité que pose la méthode multi-modèle, il n'est pas toujours possible de faire la distinction entre les effets de variables indépendantes sur la répartition des durées de survenue d'événement pour les individus à risque et leurs effets sur la probabilité d'être à risque. Nous avons réglé ces problèmes en nous servant de données issues d'un essai clinique visant à étudier la capacité d'un microbicide intravaginal à prévenir la transmission d'homme à femme des MTS. Les facteurs liés à la durée de survenue de l'infection chez les femmes à risque ont d'abord été identifiés en mettant en adéquation les modèles tronqués à droite avec les durées de survenue d'événement censurées par intervalles des participants dont le test de dépistage de MTS s'est révélé positif et qui sont donc réputés avoir été à risque. Les facteurs liés la probabilité d'être à risque ont ensuite été évalués en utilisant des estimations multi-modèles qui regroupaient des données produites par les durées sans survenue d'événement censurées à droite de participants à l'étude non infectés. (de l'auteur) Language: English Keywords: CAMEROON | RESEARCH REPORT | CLINICAL TRIALS | POPULATION AT RISK | WOMEN | SEXUALLY TRANSMITTED DISEASES | GONORRHEA | CHLAMYDIA | VAGINAL SPERMICIDES | TRANSMISSION | Africa, Western | Africa, Sub Saharan | Africa | Developing Countries | Clinical Research | Research Methodology | Demographic Factors | Population | Reproductive Tract Infections | Infections | Diseases | Contraceptive Methods | Contraception | Family Planning Document Number: 181567 |
| 25. Title: [Contraceptive efficacy of bioadhesive nonoxynol-9 gel: comparison with nonoxynol-9 suppository] Author: Xu JX; Shi LT; Zhou XB; Xiao ZQ Source: Zhonghua Fu Chan Ke Za Zhi. 2003 Oct;38(10):629-631. Abstract: Objective To compare the contraceptive efficacy of a new spermicide, bioadhesive nonoxynol (N-9) gel, with a traditional N-9 suppository. Methods A total of 240 child-bearing aged woman volunteers were randomly divided into two groups; 120 cases using the gel for contraception, and another 120 using the suppository. Using lifetable method and log rank test, we compared the pregnancy rates and other discontinuation rates after follow-up for 6 months in two groups. Results No abnormal findings of cervical smears were detected before and after this clinical trial in all 240 women. The follow-up rates at 6 months were 100.0% and 97.5% in the gel group and the suppository group, respectively. The 6-month gross cumulative pregnancy rates of typical use were 6.39 and 2.95 per 100 women (P > 0.05), respectively. If we eliminated the 5 pregnancy women (3 in the gel group, and 2 in the suppository one), who did not consistently use the spermisides for every intercourse, the cumulative pregnancy rates at 6 month in perfect use would be 3.71 and 2.03 (P > 0.05). And the discontinuation rates due to allergy or other side effects at 6 months in typical use were 3.45 and 4.57 (P > 0.05), respectively. All of the results observed between two groups in this study were not statistically significant. Conclusion The contraceptive efficacy of bioadhesive N-gel is as same as that of the N-9 suppository, and its clinical use is quite safe. (author's) Language: Chinese Keywords: RESEARCH REPORT | COMPARATIVE STUDIES | LIFE TABLE METHOD | WOMEN | VAGINAL SPERMICIDES | CERVICAL EFFECTS | PREGNANCY RATE | CONTRACEPTIVE USE-EFFECTIVENESS | SAFETY | Studies | Research Methodology | Demographic Analysis | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Cervix | Uterus | Genitalia, Female | Genitalia | Urogenital System | Physiology | Biology | Fertility Measurements | Fertility | Population Dynamics | Contraceptive Effectiveness | Public Health | Health Document Number: 277524 |
| 26. Title: Update on barrier methods. Author: Andolsek KM; Schnare SM Source: Dialogues in Contraception. 2002 Fall;7(6):4-6. Abstract: This article discusses the unique characteristics of different barrier methods suited to user's needs and preferences, and reviews their relative efficacy in the prevention of unintended pregnancy and sexually transmitted diseases in women. Language: English Keywords: LITERATURE REVIEW | BARRIER METHODS | VAGINAL SPERMICIDES | CONDOMS | FEMALE CONDOMS | CERVICAL CAP | VAGINAL SPONGE | SEXUALLY TRANSMITTED DISEASE PREVENTION | PREGNANCY, UNPLANNED | PREVENTION AND CONTROL | Contraceptive Methods | Contraception | Family Planning | Vaginal Barrier Methods | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Diseases | Reproductive Behavior | Fertility | Population Dynamics | Demographic Factors | Population Document Number: 174047 |
| 27. Peer Reviewed Title: Safety of single daily use for one week of C31G HEC gel in women. Author: Ballagh SA; Baker JM; Henry DM; Archer DF Source: Contraception. 2002 Nov;66(5):369-375. Abstract: Genital irritation and user acceptability was compared after seven nightly bedtime exposures to 1.2% C31G hydroxyethyl cellulose (HEC), 2% nonoxynol-9 (N-9) (Gynol II) or HEC vehicle alone. Sixty healthy women over 18 years old at low risk for sexually transmitted disease with normal menses were randomly assigned to one of three groups. Entrance and exit pelvic exams documented vaginal pH and Gram stain. Genital irritation was assessed by patient diaries, a telephone call 24 to 48 h after first use, colposcopy done the day after last product use, and an acceptability questionnaire at exit. Eighty percent of the women using C31G HEC experienced symptoms of vaginal burning or heat compared to 25% of the N-9 users and 5% of the vehicle users. Colposcopic findings were similar for the active treatments of C31G HEC and N-9: 50% vs. 60% developed new lesions, 25% vs. 20% had lesions that disrupted epithelial integrity, and 50% vs. 45% had minor lesions, respectively. Findings with the HEC vehicle were half as frequent. Twelve percent of women had epithelial disruption that was assessed by the colposcopist as applicator-related. Gram stains were half as likely to show bacterial vaginosis after N-9 use (6>1) and one fourth as likely after vehicle or C31G HEC use (4>1). When asked if they would use the product if it were an effective contraceptive, 55% of the vehicle users, 35% of the N-9 users, and 25% of the C31G HEC users agreed. Product acceptability of C31G HEC was limited by the sensation of heat or burning. The C31G HEC product had a similar safety profile to N-9 in this comparative trial. (author’s) Language: English Keywords: RESEARCH REPORT | CLINICAL RESEARCH | DATA ANALYSIS | ADULTS | WOMEN | MICROBICIDES | VAGINAL SPERMICIDES | GENITAL EFFECTS, FEMALE | COLPOSCOPY | SAFETY | PROGRAM ACCEPTABILITY | Research Methodology | Age Factors | Population Characteristics | Demographic Factors | Population | Drugs | Treatment | Contraceptive Methods | Contraception | Family Planning | Genitalia, Female | Genitalia | Urogenital System | Physiology | Biology | Endoscopy | Physical Examinations and Diagnoses | Examinations and Diagnoses | Public Health | Health | Program Evaluation | Programs | Organization and Administration Document Number: 173153 |
| 28. Peer Reviewed Title: Microflora changes with the use of a vaginal microbicide. Author: Clarke JG; Peipert JF; Hillier SL; Heber W; Boardman L Source: Sexually Transmitted Diseases. 2002 May;29(5):288-293. Abstract: The rate of HIV transmission is increasing more in women than in any other group. There is an urgent need for the development of microbicides with activity against this virus that women can use during intercourse. These products must be convenient, effective, and safe, and ideally they will cause minimal disruption in the normal vaginal ecosystem. The objective of this study was to evaluate changes in vaginal microflora, specifically Lactobacillus species, with the use of BufferGel. A prospective cohort study was performed to evaluate the change in vaginal flora before and after BufferGel use. BufferGel was applied vaginally once or twice daily for 14 days by low-risk abstinent and monogamous women. There was no change in frequency of Lactobacillus species after BufferGel use. However, there was a decrease in H/2O/2-producing lactobacilli (from 4.9 x 10/7 to 1.1 x 10/7 cfu; P = 0.001). The proportion of facultative gram-negative rods present increased from 27% to 65% after BufferGel use, whereas obligately anaerobic microbes decreased from 62% to 38%. Use of BufferGel once or twice daily for 14 days resulted in no clinically significant change in Lactobacillus colonization. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | PROSPECTIVE STUDIES | WOMEN | MICROBICIDES | HIV PREVENTION | VAGINAL APPROACH | VAGINAL SPERMICIDES | SAFETY | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTION RESEARCH | North America | Americas | Developed Countries | Studies | Research Methodology | Demographic Factors | Population | Drugs | Treatment | HIV Infections | Viral Diseases | Diseases | Female Sterilization | Sterilization, Sexual | Family Planning | Contraceptive Methods | Contraception | Public Health | Health Document Number: 285349 |
| 29. Title: Pre-clinical safety evaluation of novel nucleoside analogue-based dual-function microbicides (WHI-05 and WHI-07). Author: D'Cruz OJ; Uckun FM Source: Journal of Antimicrobial Chemotherapy. 2002;50:793-803. Abstract: Compounds WHI-05 [5-bromo-6-methoxy-5,6-dihydro-3'-azidothymidine-5'-(p-methoxyphenyl)-methoxyalaninyl phosphate] and WHI-07 [5-bromo-6-methoxy-5,6-dihydro-3'-azidothymidine-5'-(p-bromophenyl)-methoxyalaninyl phosphate] are aryl phosphate derivatives of zidovudine (ZDV) with anti-HIV and contraceptive activity. WHI-05 and WHI-07 differ fundamentally from currently used surfactant microbicides that are cytotoxic to genital tract epithelial cells at spermicidal concentrations. These drugs were rationally designed to bypass the thymidine kinase dependency of ZDV activation in genital tract secretions, as well as to achieve spermicidal activity. WHI-05 and WHI-07 were formulated via a non-toxic gel-microemulsion for intravaginal use as potential anti-HIV spermicides. Pre-clinical safety studies of intravaginally administered WHI-05 and WHI-07 gel-microemulsions were performed in mice and rabbits to mimic closely the intravaginal application of a microbicidal preparation in women. In addition, systemic toxicity studies were performed in mice and non-human primates. The LD(-10) doses for WHI-05 and WHI-07 when administered intravenously or intraperitoneally were >500 mg/kg for mice. Female cynomolgus monkeys treated with 20 mg/kg WHI-05 and WHI-07 intravenously developed no grade 2–4 systemic toxicities. Repetitive intravaginal administration of 2% WHI-05 and WHI-07 via a gel-microemulsion to achieve concentrations as high as 6.1 x 10(4) and 5.7 x 10(6) times their respective in vitro anti-HIV IC(-50) values, and 1200 and 5700 times their spermicidal EC(-50) values, for up to 13 weeks, was not associated with mucosal, systemic or reproductive toxicity. Furthermore, long-term (2 years) intravaginal administration of 2% WHI-07 gel-microemulsion was not associated with systemic toxicity or increased carcinogenicity in mice. The improved potency, as well as the lack of mucosal, systemic and reproductive toxicity of WHI-05 and WHI-07, means that these compounds have clinical potential as safe, prophylactic contraceptives in addition to their microbicide activity to curb the sexual transmission of HIV. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL RESEARCH | LABORATORY ANIMALS | HIV INFECTIONS | VAGINAL SPERMICIDES | MICROBICIDES | ANTIVIRAL DRUGS | PREGNANCY RATE | CANCER | CONTRACEPTION | HIV TRANSMISSION | North America | Americas | Developed Countries | Research Methodology | Viral Diseases | Diseases | Contraceptive Methods | Family Planning | Drugs | Treatment | Fertility Measurements | Fertility | Population Dynamics | Demographic Factors | Population | Neoplasms Document Number: 285345 |
| 30. Peer Reviewed Title: Dextrin sulfate as a vaginal microbicide: randomized, double-blind, placebo-controlled trial including healthy female volunteers and their male partners. Author: Low-Beer N; Gabe R; McCormack S; Kitchen VS; Lacey CJ Source: JAIDS. Journal of Acquired Immune Deficiency Syndromes. 2002 Dec 1;31(4):391-398. Abstract: This randomized, placebo-controlled trial assessed the safety and acceptability of vaginally administered 0.125% dextrin sulfate (DS) gel in sexually active women and their male partners. A single 2-mL dose of study gel was self-administered every night over two 14-day periods separated by a 7-day interval, during which menses was expected to occur. Up to two supplementary doses per 24 hours were provided for use before sexual intercourse. Semistructured interview, colposcopy, and laboratory safety studies were used to assess adverse events. Male partners who agreed to participate in a substudy were exposed to gel through sexual intercourse during the second 14-day exposure period. Seventy-three women (36 DS recipients and 37 placebo recipients) used at least one application of gel, of whom 66 (33 DS recipients and 33 placebo recipients) completed follow-up. Eleven women (5 DS recipients and 6 placebo recipients) reported intermenstrual bleeding during gel use, which in most cases was light and resolved within 24 hours. Ten male partners (4 with DS exposure and 6 with placebo exposure) were enrolled in the study and all completed follow-up. There was no evidence of systemic toxicity or genital epithelial disruption attributable to DS gel. (author’s) Language: English Keywords: UNITED KINGDOM | RESEARCH REPORT | CONTROL GROUPS | HIV PREVENTION | MICROBICIDES | WOMEN | VAGINAL SPERMICIDES | CLINICAL TRIALS | Developed Countries | Europe, Western | Europe | Research Methodology | HIV Infections | Viral Diseases | Diseases | Drugs | Treatment | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Clinical Research Document Number: 173271 |
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