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Title: Scientists recommend new design for female condom research.
Author: Family Health International [FHI]
Source: [Research Triangle Park, North Carolina], FHI, [2009]. [2] p. (Research Briefs on the Female Condom)
Abstract: As the result of a USAID-supported workshop organized by the nonprofit organization CONRAD, scientists have proposed a new design for studies testing the effectiveness of innovations in the female condom. For a female condom to gain regulatory approval in the United States, the U.S. Food and Drug Administration (FDA) currently requires that the product be tested in a large -- and often expensive -- phase III contraceptive-effectiveness trial. CONRAD held the workshop specifically so that experts on female condoms and semen biomarkers could explore acceptable alternatives to this type of trial. The experts identified the well-studied biomarker prostate-specific antigen (PSA) as the most promising marker to pursue for this application. The new study design uses PSA to show the presence of semen in the vagina, which should be a more reliable indicator of clinical condom failure than is the incidence of pregnancy or a sexually transmitted infection. A report of the workshop and the details of the study design are published in the journal Contraception. (Excerpt)
Language: English
Keywords:
UNITED STATES OF AMERICA | SUMMARY REPORT | STUDY DESIGN | WORKSHOPS | FEMALE CONDOMS | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTION RESEARCH | CONDOM FAILURE | SEMEN | ANTIGENS | VAGINA | Developed Countries | North America | Americas | Research Methodology | Education | Vaginal Barrier Methods | Barrier Methods | Contraceptive Methods | Contraception | Family Planning | Condoms | Seminal Vesicles | Genitalia, Male | Genitalia | Urogenital System | Physiology | Biology | Immunologic Factors | Immunity | Immune System | Genitalia, Female
Document Number: 331704

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Title: Nitric oxide-dependent human acrosomal loss induced by PPCM (SAMMA) and by nitric oxide donors occurs by independent pathways: basis for synthesis of an improved contraceptive microbicide.
Author: Anderson RA; Feathergill KA; Chany CJ 2nd; Jain S; Krunic A
Source: Journal of Andrology. 2009 Mar-Apr;30(2):168-82.
Abstract: PPCM (previously designated sulfuric acid-modified mandelic acid [SAMMA]) is a contraceptive microbicide in preclinical development. Its contraceptive activity is attributable in part to its ability to promote premature acrosomal loss. Prior studies showed that PPCM-induced human acrosomal loss (PAL) is Ca(2+)-dependent. This study was carried out to determine transduction elements downstream from Ca(2+) entry. PAL is inhibited by inhibitors selective for endothelial-type nitric oxide synthase. PAL is completely inhibited by 0.1 microM ODQ (soluble guanylate cyclase inhibitor). PAL is inhibited by protein kinase G inhibitors with selectivity for the type II isotype. Several inhibitors of the nitric oxide/cyclic guanosine monophosphate (cGMP)/protein kinase G pathway induce Ca(2+)-dependent acrosomal loss when added alone. These responses are inhibited by nifedipine, a blocker of Ca(v1.x) voltage-dependent channels. Acrosomal loss induced by the nitric oxide donor SNAP (SNAL) does not require added Ca(2+). Sperm production of nitric oxide is increased by PPCM, an effect inhibited by nitro-L-arginine (nitric oxide synthase inhibitor). Although inhibited by ODQ, SNAL and acrosomal loss induced by other nitric oxide donors are unaffected by KT5823 (protein kinase G inhibitor). Unlike PAL, SNAL is partially inhibited by KT5720 (protein kinase A inhibitor) and genistein (protein tyrosine kinase inhibitor). Acrosomal loss response to PPCM and SNAP added in combination suggests that these agents act by independent mechanisms. A PPCM derivative was synthesized, in which a nitric oxide donor was esterified to PPCM (NOSPPA-23). NOSPPA-23 induces acrosomal loss with or without added Ca(2+). The ED(50) of NOSPPA-23 (4.8 nM) in the presence of Ca(2+) is 35-fold less than that of PPCM. These findings suggest the following: 1) elements responsible for PAL include endothelial nitric oxide synthase, soluble guanylate cyclase, and type II protein kinase G; 2) the resting state of the nitric oxide/cGMP/protein kinase G pathway is a determinant of acrosomal status; 3) PPCM and nitric oxide donors induce acrosomal loss via nitric oxide, but through independent pathways; and 4) covalent attachment of a nitric oxide donor to PPCM provides synergistic efficacy as a stimulus of acrosomal loss. Further studies with this novel prototype as an improved contraceptive microbicide are warranted.
Language: English
Keywords:
UNITED STATES OF AMERICA | ILLINOIS | RESEARCH REPORT | MICROBICIDES | DRUGS | CONTRACEPTION RESEARCH | Developed Countries | North America | Americas | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraception | Family Planning
Document Number: 331202

3.
Title: Role of the calcium channel in blastocyst implantation: a novel contraceptive target.
Author: Banerjee A; Padh H; Nivsarkar M
Source: Journal of Basic and Clinical Physiology and Pharmacology. 2009;20(1):43-53.
Abstract: The proinflammatory blastocyst implantation cascade involves important mediators like prostaglandins (PG). The influx of calcium via the calcium channel acts as a trigger for the activation of the PG synthesis pathway. Hence, it was hypothesized that calcium channel blockers that are known to possess anti-inflammatory activity may interfere with normal implantation. Pregnant Swiss albino mice (Mus musculus) were treated with diltiazem (1) 4 mg/kg, po on days 1-6 of pregnancy, n=6/day) or (2) at the implantation site (25 microg/animal) via intrauterine injection in the right horn at 5:00 pm on day 4. The intact uterus was used to assay lipid peroxidation and superoxide dismutase activity as markers of membrane fluidity or to observe the day 15 fetus. Oral diltiazem treatment in therapeutic dosage before and during the implantation period did not cause any change in normal uterine milieu during the window of implantation. When injected into the uterine lumen 12-14 h before the average implantation time, however, a complete failure in implantation was observed. Thus, the site specific action of diltiazem may be blocking prostaglandin synthesis, hence causing implantation failure. Oral diltiazem treatment did not mimic this action, indicating that although orally safe in pregnancy in therapeutic dosage, calcium channel blockers may provide a new and yet unknown target in female contraceptive research.
Language: English
Keywords:
INDIA | RESEARCH REPORT | CLINICAL RESEARCH | LABORATORY PROCEDURES | LABORATORY ANIMALS | LIPID METABOLIC EFFECTS | CONTRACEPTION RESEARCH | Asia, Southern | Asia | Developing Countries | Research Methodology | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Lipids | Physiology | Biology | Contraception | Family Planning
Document Number: 342045

Peer Reviewed

Title: Satisfaction and compliance in hormonal contraception: the result of a multicentre clinical study on women's experience with the ethinylestradiol/norelgestromin contraceptive patch in Italy.
Author: Crosignani PG; Nappi C; Ronsini S; Bruni V; Marelli S; Sonnino D; Study Group IE
Source: BMC Women's Health. 2009 Jun 30;9(1):18.
Abstract: ABSTRACT: BACKGROUND: For many women finding the right contraceptive method can be challenging and consistent and correct use over a lifetime is difficult. Even remembering to take a birth control pill every day can be a challenge. The primary objective of this study was to evaluate women's experience with a weekly ethinylestradiol/norelgestromin contraceptive patch (EE/NGMN patch), given new technologies recently developed in hormonal contraception to increase women's options in avoiding daily dosing. METHODS: In 24 Italian sites, 207 women received the EE/NGMN patch for up to 6 cycles. At study end, overall satisfaction and preference, as well as compliance, efficacy and safety, were evaluated. RESULTS: 175 women (84.5%) completed the study. The overall satisfaction rate was 88%; convenience and once-a-week frequency of the patch were especially appreciated. At baseline, 82 women (39.4%) were using a contraceptive method, mainly oral contraceptives and barrier methods, but only 45.1% were very satisfied/satisfied; after 6 months with the patch, 86.3% of this subset was very satisfied/satisfied. Considering the method used in the 3 months before the study entry, 78.1% strongly preferred/preferred the patch, for convenience (53.9%), ease of use/simplicity (28.9%), fewer (9.2%) and less severe (2.6%) side effects. Compliance was very high: 1034/1110 cycles (93.2%) were completed with perfect compliance and the mean subject's compliance score was 90%. One on-therapy pregnancy occurred. The patch was safe and well tolerated: adverse events frequency was low, with predominantly single reports of each event. Most of them started and subsided during cycle 1. CONCLUSIONS: This study demonstrated that the EE/NGMN patch is associated with high satisfaction levels and excellent compliance. At study end, the majority of women indicated that they would continue using the patch.
Language: English
Keywords:
ITALY | RESEARCH REPORT | FAMILY PLANNING ACCEPTORS | CONTRACEPTION RESEARCH | CONTRACEPTIVE METHODS | ETHINYL ESTRADIOL | CONTRACEPTIVE AGENTS, PROGESTIN | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE SAFETY | SATISFACTION | USER COMPLIANCE | Developed Countries | Europe, Southern | Europe | Family Planning Programs | Family Planning | Contraception | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Safety | Public Health | Health | Psychological Factors | Behavior
Document Number: 341863

Peer Reviewed

Title: Preclinical characterization of a (S)-N-(4-cyano-3-trifluoromethyl-phenyl)-3-(3-fluoro, 4-chlorophenoxy)-2-hydroxy-2-methyl-propanamide: a selective androgen receptor modulator for hormonal male contraception.
Author: Jones A; Chen J; Hwang DJ; Miller DD; Dalton JT
Source: Endocrinology. 2009 Jan;150(1):385-95.
Abstract: The pharmacologic effects of (S)-N-(4-cyano-3-trifluoromethyl-phenyl)-3-(3-fluoro, 4-chlorophenoxy)-2-hydroxy-2-methyl-propanamide (S-23) were characterized in male rats as an animal model of hormonal male contraception. S-23 showed high binding affinity (inhibitory constant = 1.7 +/- 0.2 nm) and was identified as a full agonist in vitro. In castrated male rats, the ED50 of S-23 in the prostate and levator ani muscle was 0.43 and 0.079 mg/d, respectively. In intact male rats treated for 14 d, S-23 alone suppressed LH levels by greater than 50% at doses greater than 0.1 mg/d, with corresponding decreases in the size of the prostate but increases in the size of levator ani muscle. In intact male rats treated for up to 10 wk with S-23 and estradiol benzoate (EB; necessary to maintain sexual behavior in rats), S-23 showed biphasic effects on androgenic tissues and spermatogenesis by suppressing serum concentrations of LH and FSH. EB alone showed no effect on spermatogenesis. In the EB + S-23 (0.1 mg/d) group, four of six animals showed no sperm in the testis and zero pregnancies (none of six) in mating trials. After termination of treatment, infertility was fully reversible, with a 100% pregnancy rate observed after 100 d of recovery. S-23 increased bone mineral density and lean mass but reduced fat mass in a dose-dependent manner. This is the first study to show that a selective androgen receptor modulator combined with EB is an effective and reversible regimen for hormonal male contraception in rats. The beneficial effects of S-23 on the muscle, tissue selectivity, and favorable pharmacokinetic properties make it a strong candidate for use in oral male contraception.
Language: English
Keywords:
UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL RESEARCH | ANIMALS | LABORATORY ANIMALS | MALE CONTRACEPTION | HORMONE ANTAGONISTS | REVERSIBILITY | CONTRACEPTION RESEARCH | Developed Countries | North America | Americas | Research Methodology | Natural Resources | Environment | Contraception | Family Planning | Hormones | Endocrine System | Physiology | Biology
Document Number: 330565

Peer Reviewed

Title: Levonorgestrel enhances spermatogenesis suppression by testosterone with greater alteration in testicular gene expression in men.
Author: Lue Y; Wang C; Cui Y; Wang X; Sha J; Zhou Z; Xu J; Wang C; Hikim AP; Swerdloff RS
Source: Biology of Reproduction. 2009 Mar;80(3):484-92.
Abstract: Prior studies have demonstrated that combined treatment of testosterone with a progestin induces a more rapid and greater suppression of spermatogenesis than testosterone treatment alone. We hypothesized that the suppressive effects of the combination of testosterone undecanoate (TU) injections plus oral levonorgestrel (LNG) on spermatogenesis may be mediated through a greater perturbation of testicular gene expression than TU alone. To test this hypothesis, we performed open testicular biopsy on 12 different adult healthy subjects: 1) four healthy men as controls; 2) four men 2 wk after TU treatment; and 3) four men 2 wk after TU + LNG administration. RNA isolated from biopsies was used for DNA microarray using the Affymetrix Human Genome U133 Plus 2.0 oligonucleotide microarrays. Gene expression with >or=2-fold changes (P < 0.05) compared with control was analyzed using the National Institutes of Health Database for Annotation, Visualization, and Integrated Discovery 2008 resource. The TU treatment altered the gene expression in 109 transcripts, whereas TU + LNG altered the gene expression in 207 transcripts compared with control. Both TU and TU + LNG administration suppressed gene expression of insulin-like 3; cytochrome P450, family 17, subfamily A1 in Leydig cells; and inhibin alpha in Sertoli cells; they increased proapoptotic transcripts BCL2-like 14, insulin-like growth factor-binding protein 3; and they decreased X-linked inhibitor of apoptosis protein. In comparison with TU treatment alone, TU + LNG treatment upregulated insulin-like 6 and relaxin 1, and downregulated RNA-binding protein transcripts. We conclude that TU + LNG administration induces more changes in testicular gene expression than TU alone. This exploratory study provided a novel and valuable database to study the mechanisms of action of hormonal regulation of spermatogenesis in men and identified testicular-specific molecules that may serve as potential targets for male contraceptive development.
Language: English
Keywords:
UNITED STATES OF AMERICA | RESEARCH REPORT | MEN | MALE CONTRACEPTION | PROGESTERONE | SPERMATOGENESIS | TESTIS | TESTOSTERONE | CONTRACEPTION RESEARCH | LEVONORGESTREL | Developed Countries | North America | Americas | Demographic Factors | Population | Contraception | Family Planning | Progestational Hormones | Hormones | Endocrine System | Physiology | Biology | Reproduction | Genitalia, Male | Genitalia | Urogenital System | Androgens | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents
Document Number: 341724

10.

Title: Methods for Female Contraception: A Model for Innovation in Drug Delivery Systems.
Author: Merkatz R; Tokay B; Sitruk-Ware R
Source: Clinical Pharmacology and Therapeutics. 2009 May;85(5):553-557.
Abstract: In 2007, 1.7 billion women were in need of contraception, but only 57% of them were using modern contraceptives.1 During a woman's 30-year reproductive life, her contraceptive needs may vary from postponing childbearing to spacing out the births of her children and, finally, to limiting family size. Modern contraceptive methods and their delivery systems reflect these changing needs as well as the challenges associated with the long-term regulation of conception, which are similar to the challenges encountered in developing therapeutics for chronic medical conditions. The lessons learned during the development of modern contraceptive methods may be relevant to the development of therapeutics for chronic medical conditions requiring treatment throughout the life cycle. Despite advances in contraception, many women who wish to avoid pregnancy either choose not to use contraception, do not have access to a suitable method, or use a method incorrectly resulting in millions of unintended pregnancies each year accompanied by significant morbidity and mortality. Clearly, improvements in methods have contributed to the increased use of contraception worldwide, but current user-controlled methods could be further improved to promote greater adherence. It would be helpful to ease restrictions on access to medical care and contraceptive supplies because such restrictions limit the use of contraceptives, particularly the longacting, reversible methods that are associated with higher rates of compliance. Further advances in the field of contraception will require targeted development of new and improved methods combined with country-specific changes in policy and funding in order to ensure access to these methods.
Language: English
Keywords:
UNITED STATES OF AMERICA | RESEARCH REPORT | WOMEN | CONTRACEPTION | DELAYED CHILDBEARING | BIRTH SPACING | CONTRACEPTIVE METHODS | CONTRACEPTION RESEARCH | PROGRAM ACCESSIBILITY | Developed Countries | North America | Americas | Demographic Factors | Population | Family Planning | Reproductive Behavior | Fertility | Population Dynamics | Program Evaluation | Programs | Organization and Administration
Document Number: 330734

11.

Title: Male hormonal contraception: love's labour's lost? [editorial]
Author: Nieschlag E
Source: Journal of Clinical Endocrinology and Metabolism. 2009 Jun;94(6):1890-2.
Abstract: Although a large proportion of clinical research is driven by the pharmaceutical industry, in the case of male contraception, industry fails. Without the long-range perspective and endurance of institutions and organizations such as the National Institute of Child Health and Human Development, CONRAD, Population Council, WHO, some medical research councils, and a few foundations, male contraception would long ago have been abandoned. The principle and effectiveness of hormonal male contraception has been demonstrated in many studies, crowned by the most recent trial in the current issue of the Journal of Clinical Endocrinology and Metabolism. The fact that the majority of clinical trials on hormonal male contraception have been published in this journal emphasizes the high priority the scientific community attributes to these endeavors. Little more is required to convince industry to bring this development to fruition. Comparing the situation with the development of the female pill, the lack of public advocacy for male contraception is striking. Male contraception lacks prominent advocates, whereas the development of female contraception benefited from personalities such as Margaret Sanger (1879-1966) and Katherine McCormick (1875-1967). Were Arnold Schwarzenegger or Barack Obama to advocate male contraception, it would become a marketable entity in no time! (excerpt)
Language: English
Keywords:
DEVELOPING COUNTRIES | SUMMARY REPORT | MALE CONTRACEPTION | CULTURE | CONTRACEPTION RESEARCH | CONTRACEPTIVE EFFECTIVENESS | Contraception | Family Planning | Sociocultural Factors
Document Number: 341528

13.

Title: Fabrication, characterization and in vivo studies of biodegradable gamma sterilized injectable microparticles for contraception.
Author: Puthli SP; Vavia PR
Source: Pharmaceutical Development and Technology. 2009 Feb 23;:1-7.
Abstract: A Levonorgestrel-loaded microparticulate system was developed with gelatin and bovine serum albumin using triple emulsion technique coupled with chemical cross-linking thermal rigidization method. The formulation was optimized for various formulation variables and process parameters. The microparticulate system was characterized by scanning electron microscopy, encapsulation efficiency, moisture content, IR, DSC, XRD, residual solvent content and evaluated for sterility, abnormal toxicity and absence of pyrogens. Microparticles were sterilized by gamma irradiation at 2.5 Mrad. The system was injected intramuscularly in rabbits and drug blood levels estimated using radioimmunoassay technique. An optimized drug to polymer ratio of 0.4:0.75 w/w gave drug encapsulation efficiency of about 40%. The in vitro drug release followed Higuchi square root kinetics. In in vivo studies the AUC0-t was found to be 12849.25 pg/mL.day(-1) with mean residence time calculated to be about 16 days and Kel of 0.02 day(-1). Levonorgestrel (LNG) levels were maintained between 200 and 400 pg/mL. The pharmacokinetic results indicate that LNG is released from the injectable microparticles for a period of one-month duration.
Language: English
Keywords:
INDIA | RESEARCH REPORT | CONTRACEPTION RESEARCH | LEVONORGESTREL | INJECTABLES | IN VITRO | LABORATORY PROCEDURES | Asia, Southern | Asia | Developing Countries | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Methods | Clinical Research | Research Methodology | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health
Document Number: 330419

14.

Title: Women and contraception in research: a pilot study.
Author: Schonfeld TL; Amoura NJ; Stoner JA; Gordon BG
Source: Journal of Women's Health. 2009 Apr;18(4):507-12.
Abstract: BACKGROUND: There are no data on women's willingness to participate in clinical trials as a function of real or perceived reproductive risk. Further, it is unknown whether the requirement for contraception or the common practice of limiting women's contraceptive choices influences their willingness to participate in research. The uncertainty about women's preferences on these matters remains a barrier for recruiting women to and retaining women as subjects in clinical trials. METHODS: We developed a pilot study to determine women's willingness to participate in research with contraceptive requirements by looking at the three most common types of reversible contraceptives: hormonal contraception, barrier contraception, and intrauterine contraception. This study tested the hypotheses that restrictions on contraceptive choice impact women's willingness to participate in research and that the impact of contraceptive choice differs depending on women's perception of risk. RESULTS: Women's willingness to participate in the proposed study decreased overall as reproductive risk increased. In addition, requirements for specific contraceptive methods negatively impacted women's reported willingness to participate in the research studies in our survey. CONCLUSIONS: Results suggest that requirements for specific contraceptive methods negatively impacted women's reported willingness to participate in research. If confirmed in a larger sample, the negative effect of contraceptive limitations on women's willingness to participate in research would be of importance to clinical investigators and to institutional review boards (IRBs), as most adult biomedical research has as an explicit goal the equitable recruitment of women of childbearing potential.
Language: English
Keywords:
UNITED STATES OF AMERICA | RESEARCH REPORT | PILOT PROJECTS | KAP SURVEYS | CLINICAL TRIALS | WOMEN | HUMAN VOLUNTEERS | SELF-PERCEPTION | REPRODUCTIVE HEALTH | RISK ASSESSMENT | PARTICIPATION | CONTRACEPTION RESEARCH | CONTRACEPTIVE METHODS CHOSEN | Developed Countries | North America | Americas | Studies | Research Methodology | Surveys | Sampling Studies | Clinical Research | Demographic Factors | Population | Perception | Psychological Factors | Behavior | Health | Evaluation | Social Behavior | Contraception | Family Planning | Contraceptive Usage
Document Number: 330975

15.

Title: Encouraging news in the development of a new female condom.
Author: Family Health International [FHI]
Source: [Research Triangle Park, North Carolina], FHI, [2008]. [2] p. (Research Briefs on the Female Condom)
Abstract: According to a USAID-supported study led by CONRAD, and for which Family Health International managed the data and provided statistical support, couples prefer a new female condom developed by the Program for Appropriate Technology (PATH) to the only female condom currently on the market in the United States. Researchers tested the new product -- known as the Woman's Condom (WC) -- among 75 couples recruited at three clinical centers in the United States. The couples were asked to compare their experiences with the WC to their experiences using the available Female Condom (FC1). The order in which the couples tried the condoms was randomly assigned, but they all used four of each type of condom over a two- to four-week period. Results reported in a recent issue of the journal Contraception showed that the WC failed less often than the FCI and caused less female urogenital irritation. Of the people who reported a preference, twice as many preferred the WC. The FC1 is safe and has been shown to be acceptable for short-term use, but it has not been a popular method of birth control. According to the results of this study, the WC is easier to use and is generally preferred over the FC1. Because of these encouraging results, the researchers call for further development of PATH's WC -- a promising, new, female-controlled barrier method of contraception. (Full text)
Language: English
Keywords:
UNITED STATES OF AMERICA | SUMMARY REPORT | COMPARATIVE STUDIES | COUPLES | FEMALE CONDOMS | CONTRACEPTION RESEARCH | CONTRACEPTIVE METHOD ACCEPTABILITY | CONDOM FAILURE | UROGENITAL EFFECTS | Developed Countries | North America | Americas | Studies | Research Methodology | Family Characteristics | Family and Household | Sociocultural Factors | Vaginal Barrier Methods | Barrier Methods | Contraceptive Methods | Contraception | Family Planning | Contraceptive Usage | Condoms | Urogenital System | Physiology | Biology
Document Number: 331705

16.

Title: As the world grows: Contraception in the 21st century.
Author: Aitken RJ; Baker MA; Doncel GF; Matzuk MM; Mauck CK
Source: Journal of Clinical Investigation. 2008 Apr;118(4):1330-1343.
Abstract: Contraceptives that are readily available and acceptable are required in many poorer countries to reduce population growth and in all countries to prevent maternal morbidity and mortality arising from unintended pregnancies. Most available methods use hormonal steroids or are variations of barrier methods. Reports from several fora over the last 12 years have emphasized the number of unwanted pregnancies and resultant abortions, which indicate an unmet need for safe, acceptable, and inexpensive contraceptive methods. This unmet need can be assuaged, in part, by development of new nonhormonal contraceptive methods. This Review addresses the contribution that the "omic" revolution can make to the identification of novel contraceptive targets, as well as the progress that has been made for different target molecules under development. (author's)
Language: English
Keywords:
GLOBAL | LITERATURE REVIEW | CONTRACEPTION | CONTRACEPTIVE METHODS | CONTRACEPTION RESEARCH | CONTRACEPTIVE MODE OF ACTION | Family Planning
Document Number: 326107

17.

Peer Reviewed

Title: Male contraception: what is on the horizon?
Author: Blithe D
Source: Contraception. 2008 Oct;78(4 Suppl 1):S23-S27.
Abstract: Male contraception remains an important area of research. Methods can inhibit sperm production or can be targeted to inhibit sperm functions such as motility, orientation or interaction with the egg. Hormonal methods appear to be safe and effective in proof of concept studies but efforts are underway to improve delivery options or lead time until full efficacy is achieved. Nonhormonal methods are based on numerous targets that impact sperm production or function. Several agents that inhibit the sperm-specific or testis-specific targets have been identified and studies in animals have shown promising results. (author's)
Language: English
Keywords:
GLOBAL | MALE CONTRACEPTION | CONTRACEPTIVE AGENTS, MALE | SPERMATOGENESIS | OBSTACLES | CONTRACEPTION RESEARCH | Contraception | Family Planning | Contraceptive Agents | Reproduction | Organization and Administration
Document Number: 328204

18.

Title: Synthesis and in vivo evaluation of 11-substituted estradiol derivatives as anti-implantation agents.
Author: Dwivedy I; Gupta A; Grover A; Srivastava V; Singth MM
Source: Bioorganic and Medicinal Chemistry Letters. 2008;:[4] p.
Abstract: Synthesis of 11-substituted estradiol derivatives (12-17) has been carried out by the Grignard reaction with alkyl, allyl, and benzyl halides on 17beta-hydroxy-3-methoxy-11-oxo-estra-1,3,5(10),8(9)-tetraene (10). The novel compounds (10 and 12-17) were evaluated for their preliminary post-coital contraceptive (anti-implantation) activity in Sprague-Dawley rats. The tested compounds were administered orally and showed significant anti-implantation activity. Compound 13 is the most potent compound in the series which showed 100% contraceptive efficacy at 1.25 mg kg-1. (author's)
Language: English
Keywords:
GLOBAL | CLINICAL RESEARCH | LABORATORY ANIMALS | ESTROGENS | CONTRACEPTION RESEARCH | IMPLANTATION | Research Methodology | Hormones | Endocrine System | Physiology | Biology | Contraception | Family Planning | Pregnancy, First Trimester | Pregnancy | Reproduction
Document Number: 327068

19.

Peer Reviewed

Title: Public-private partnerships advance contraceptive research and development.
Author: Harper MJ
Source: Contraception. 2008 Oct;78(4 Suppl 1):S36-S41.
Abstract: The concept of public-private partnerships as a way to tackle global health problems is discussed. It is noted that surveys of such partnerships have not included contraception and contraceptive research and development (R&D), since pregnancy is not regarded as a disease. Nevertheless, there has been an attempt to apply the concept to improve maternal health through establishment of the Consortium for Industrial Collaboration in Contraceptive Research (CICCR) and its involvement with the AMPPA projects. The outcome of the CICCR initiative is discussed. Actions for the future are outlined. (author's)
Language: English
Keywords:
GLOBAL | RESEARCH REPORT | CONTRACEPTION | CONTRACEPTION RESEARCH | MALE CONTRACEPTION | RESEARCH AND DEVELOPMENT | PUBLIC SECTOR | PRIVATE SECTOR | Family Planning | Technology | Economic Factors | Macroeconomic Factors
Document Number: 328202

20.

Peer Reviewed

Title: A randomized, placebo-controlled trial to assess the safety and acceptability of use of Carraguard vaginal gel by heterosexual couples in Thailand.
Author: Kilmarx PH; Blanchard K; Chaikummao S; Friedland BA; Srivirojana N
Source: Sexually Transmitted Diseases. 2008 Mar;35(3):226-232.
Abstract: The objectives were to determine the safety and acceptability of use of Carraguard, a carrageenan-derived candidate microbicide gel, during sexual intercourse in women and men. We conducted a 6-month randomized, placebo-controlled trial among sexually active, couples at relatively lower risk for HIV infection in northern Thailand. Women inserted 1 applicator of study gel vaginally every time the couple had sex. Safety was assessed by symptom report and genital examination of both partners and by changes in vaginal flora. Acceptability was assessed by participant interview. Overall, 55 couples were randomized, 28 to Carraguard use and 27 to the methyl-cellulose placebo gel group. Retention and study gel use were similarly high in both study groups; use of gel without condoms was reported in more than 95% of vaginal sex acts. The 2 study groups were similar in the proportions of women and men with symptoms or with genital findings without epithelial disruption, of men with findings with epithelial disruption, and of women with abnormal genital flora, whereas more women in the placebo group had findings with epithelial disruption. Women and men in both groups reported that the gel and applicator were acceptable. Carraguard can safely be used an average of 2 to 3 times per week during sex and is acceptable to Thai women and men. (author's)
Language: English
Keywords:
THAILAND | RESEARCH REPORT | CONTROL GROUPS | CONTRACEPTION RESEARCH | HETEROSEXUALS | COUPLES | PERSONS LIVING WITH HIV/AIDS | VAGINAL GEL | MICROBICIDES | CONTRACEPTIVE METHOD ACCEPTABILITY | SEXUALLY TRANSMITTED DISEASE PREVENTION | SAFETY | Asia, Southeastern | Asia | Developing Countries | Research Methodology | Contraception | Family Planning | Sex Behavior | Behavior | Family Characteristics | Family and Household | Sociocultural Factors | HIV Infections | Viral Diseases | Diseases | Vaginal Spermicides | Contraceptive Methods | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Usage | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Public Health
Document Number: 324890

21.

Peer Reviewed

Title: Approaches to the identification of new nonhormonal targets for male contraception.
Author: Kopf GS
Source: Contraception. 2008 Oct;78(4 Suppl 1):S18-S22.
Abstract: Fertility control is a global health issue with major personal and societal impact. Although, currently, there are several different options for contraception, the technologies behind these are antiquated, and the options for male-based contraception (i.e., withdrawal, condom and vasectomy) are inadequate. The genomic, proteomic and bioinformatic revolutions have provided new tools and new targets for contraceptive development, and the results of such approaches have identified gene products that play critical roles in male reproduction, thus expanding the array of potential targets for novel and innovative male-based contraceptives. This article will review the types of targets being considered in the development of nonhormonal male contraceptives and the technologies used to identify and validate these targets. (author's)
Language: English
Keywords:
GLOBAL | LITERATURE REVIEW | MALE CONTRACEPTION | CONTRACEPTION RESEARCH | RESEARCH AND DEVELOPMENT | SPERMATOGENESIS | GENETIC TECHNIQUES | Contraception | Family Planning | Technology | Economic Factors | Reproduction | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health
Document Number: 328205

22.

Peer Reviewed

Title: Chenopodium album seed extract-induced sperm cell death: Exploration of a plausible pathway.
Author: Kumar S; Chatterjee R; Dolai S; Adak S; Kabir SN
Source: Contraception. 2008 Jun;77(6):456-462.
Abstract: This study was conducted for to explore the plausible pathway of Chenopodium album seed extract (CAE)-mediated sperm cell death. The role of CAE for its spermicidal action was assessed by (a) measuring lipid peroxidation, protein carbonyl content and intracellular glutathione content in CAE exposed sperm cells; (b) assaying antioxidant enzymes like catalase and superoxide dismutase (SOD); (c) analyzing protein expressions by using sodium dodecyl sulfate-polyacrylamide gel electrophoresis and Western blot analysis; (d) fluorimetric measurement of intracellular H2O2 level and generation of reactive oxygen species (ROS) in CAE-treated sperm cells; and (e) DNA ladder formation study. CAE-induced sperm death is due to (a) lipid peroxidation of the sperm cell membrane, oxidation of some critical cellular proteins and depletion of intracellular reduced gluthathione, indicating production of ROS; (b) activation of Mn-SOD and inactivation of catalase favoring endogenous accumulation of H2O2; (c) generationof O2 at an enhanced rate during oxidative stress as evidenced by increased Mn-SOD activity and protein expression; (d) accumulation of ROS in spermatozoa reflected in the fluorimetric experiments; and (e) increased production of O2 and H2O2 induced apoptosis-like death in sperm cells as observed by DNA ladder formation. The sperm death mediated by CAE is due to oxidative damage of cellular macromolecules by in situ generation of ROS. (author's)
Language: English
Keywords:
INDIA | RESEARCH REPORT | CLINICAL RESEARCH | LABORATORY ANIMALS | CONTRACEPTION RESEARCH | SPERMATOGENESIS BLOCKING AGENTS | SPERMICIDAL CONTRACEPTIVE AGENTS | Developing Countries | Asia, Southern | Asia | Research Methodology | Contraception | Family Planning | Contraceptive Agents, Male | Contraceptive Agents
Document Number: 326729

23.

Title: New perspectives in non-hormonal male contraception.
Author: Mruk DD
Source: Trends in Endocrinology and Metabolism. 2008 Mar;19(2):57-64.
Abstract: As the world's population continues to soar, contraception has become increasingly important. Recently, men have expressed willingness to share the burden of family planning. Thus, safe, effective and reversible male contraceptives would satisfy an urgent need among couples. Currently, there are several promising non-hormonal contraceptives at various stages of research and development. In addition, major advances in genomic and proteomic research have been instrumental in identifying and characterizing genes and proteins expressed uniquely in the testis or other male reproductive organs, which might become 'druggable' targets for non-hormonal male contraceptive development in the future. Through committed research, advocacy and support, male contraceptives are likely to become a valuable addition to the current choices of family planning. (author's)
Language: English
Keywords:
GLOBAL | LITERATURE REVIEW | MALE CONTRACEPTION | CONTRACEPTION RESEARCH | CONTRACEPTIVE SAFETY | REVERSIBILITY | Contraception | Family Planning | Safety | Public Health | Health
Document Number: 325043

24.

Title: Oral contraceptives.
Author: Oesterheld JR; Cozza K; Sandson NB
Source: Psychosomatics. 2008 Mar-Apr;49(2):168-175.
Abstract: Many formulations of OCs are now available. Monophasic preparations contain the same amount of EE and progestin and are taken for 21 days of each 28-day cycle. Biphasic and triphasic preparations take the form of two or three types of pills, with varying amounts of active ingredients. Biphasic and triphasic OCs have been formulated so that the amount of progestin is reduced and the effects correspond more closely to hormonal influences during natural menstrual cycles. Recently, several formulations of continuous daily regimens of ethinylestradiol (10 microg and 30 microg) and a progestin have entered the market. These formulations allow withdrawal-bleeding periods only 4 times a year. A yearly, no-cycling version of levonorgestrel and EE (Lybrel) received FDA approval in May 2007. There are a limited number of progestin-only contraceptives. These contraceptives are the mini-pill containing norethindrone, norgestrel, or levonorgestrel; a subdermal implant of norgestrel (Norplant II); intramuscular and subcutaneous preparations of medroxyprogesterone acetate and norethindrone enanthate, administered every 3 months; and intrauterine devices that release progesterone and levonorgestrel. (excerpt)
Language: English
Keywords:
UNITED STATES OF AMERICA | MARYLAND | RESEARCH REPORT | CONTRACEPTION RESEARCH | DRUG INTERACTIONS | ORAL CONTRACEPTIVES | DRUGS | SIDE EFFECTS | Developed Countries | North America | Americas | Contraception | Family Planning | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Methods
Document Number: 326618

25.

Peer Reviewed

Title: Isolation of human single chain variable fragment antibodies against specific sperm antigens for immunocontraceptive development.
Author: Samuel AS; Naz RK
Source: Human Reproduction. 2008;23(6):1324-1337.
Abstract: Contraceptive vaccines can provide valuable alternatives to current methods of contraception. We describe here the development of sperm-reactive human single chain variable fragment (scFv) antibodies of defined sperm specificity for immunocontraception. Peripheral blood leukocytes (PBL) from antisperm antibody-positive immunoinfertile and vasectomized men were activated with human sperm antigens in vitro, and the complementary DNA prepared and PCR-amplified using primers based on all the variable regions of heavy and light chains of immunoglobulins. The scFv repertoire was cloned into pCANTAB5E vector to create a human scFv antibody library. Panning of the library against specific sperm antigens yielded several clones, and the four strongest reactive were selected for further analysis. These clones had novel sequences with unique complementarity-determining regions. ScFv antibodies were expressed, purified and analyzed for human sperm reactivity and effect on human sperm function. AFA-1 and FAB-7 scFv antibodies both reacted with fertilization antigen-1 antigen, but against different epitopes. YLP20 antibody reacted with the expected human sperm protein of 48 plus or minus 5 kDa. The fourth antibody, AS16, reacted with an 18 kDa sperm protein and seems to be a human homologue of the mouse monoclonal recombinant antisperm antibody that causes sperm agglutination. All these antibodies inhibited human sperm function. This is the first study to report the use of phage display technology to obtain antisperm scFv antibodies of defined antigen specificity. These antibodies will find clinical applications in the development of novel immunocontraceptives, and specific diagnostics for immunoinfertility. (author's)
Language: English
Keywords:
UNITED STATES OF AMERICA | WEST VIRGINIA | RESEARCH REPORT | LABORATORY PROCEDURES | IN VITRO | INFERTILITY | ANTIBODIES | ANTIGENS | CONTRACEPTION RESEARCH | VACCINES | Developed Countries | North America | Americas | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Clinical Research | Research Methodology | Reproduction | Immunologic Factors | Immunity | Immune System | Physiology | Biology | Contraception | Family Planning
Document Number: 326617

26.

Title: Spermicidal bacteriocins: Lacticin 3147 and subtilosin A.
Author: Silkin L; Hamza S; Kaufman S; Cobb SL; Vederas JC
Source: Bioorganic and Medicinal Chemistry Letters. 2008 May 15;18(10):3103-3106.
Abstract: Spermicidal compounds that also exhibit antimicrobial properties would be extremely attractive agents as they could be used to not only prevent unwanted pregnancy but also to combat the growing prevalence of sexually transmitted infections (STI). One class of compounds that are potential candidates for development of dual-acting contraceptive products are antimicrobial peptides (AMPs). Herein, we report preliminary studies carried out to investigate the spermicidal activity of two bacteriocins, lacticin 3147 and subtilosin A, on bovine, horse/pony, boar and rat sperm. (author's)
Language: English
Keywords:
GLOBAL | CLINICAL RESEARCH | LABORATORY ANIMALS | MICROBICIDES | CONTRACEPTION RESEARCH | SPERMICIDAL CONTRACEPTIVE AGENTS | SEXUALLY TRANSMITTED DISEASE PREVENTION | DUAL PROTECTION | Research Methodology | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraception | Family Planning | Contraceptive Agents | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Diseases | Contraceptive Methods
Document Number: 327069

27.

Peer Reviewed

Title: Using formal consensus methods to adapt World Health Organization Medical Eligibility Criteria for contraceptive use.
Author: Stephen G; Brechin S; Glasier A
Source: Contraception. 2008 Oct;78(4):300-308.
Abstract: Most contraceptive users are medically fit and can use any available method. Some medical conditions are associated with theoretical safety concerns when certain contraceptives are used. Nevertheless, most contraceptive clinical trials exclude subjects with chronic medical conditions, and direct evidence on which to base sound contraceptive prescribing is limited. The World Health Organization (WHO) Medical Eligibility Criteria provide recommendations on the safe use of contraception. This document is aimed at policymakers and program managers working in less developed countries in which the risks of pregnancy usually far outweigh the risks associated with contraceptive use. The Faculty of Sexual and Reproductive Healthcare used formal consensus methods to adapt the WHO document to reflect clinical practice and health care systems in the United Kingdom. This structured group consensus method adds authority, rationality and scientific credibility to the UK version, which makes best use of publishedevidence and captures collective expert knowledge. Not all clinicians will agree with the recommendations made in the UK version of the Medical Eligibility Criteria, but for the vast majority, they will be a valuable reference to guide clinical practice for women with many conditions that theoretically affect contraceptive use. (author's)
Language: English
Keywords:
UNITED KINGDOM | GLOBAL | DEVELOPING COUNTRIES | RESEARCH REPORT | WHO | CONTRACEPTION RESEARCH | CONTRACEPTIVE SAFETY | RISK FACTORS | RECOMMENDATIONS | POLICYMAKERS | Developed Countries | Europe, Western | Europe | UN | International Agencies | Organizations | Political Factors | Sociocultural Factors | Contraception | Family Planning | Safety | Public Health | Health | Biology | Administrative Personnel | Organization and Administration
Document Number: 328077

28.

Peer Reviewed

Title: Male condoms that break in use do so mostly by a "blunt puncture" mechanism.
Author: White ND; Hill DM; Bodemeier S
Source: Contraception. 2008 May;77(5):360-365.
Abstract: Published condom breakage studies typically report the percentage of failures but rarely provide any evidence on the mechanism of failure. Over a period of 7 years, broken condoms returned to a supplier (SSL, Durex) via consumer complaints were examined to determine the cause of failure. Also, some consumers who reported breakage but did not return condoms were sent a questionnaire on the causes of breakage. Finally, theories proposed for the mechanism of breakage were investigated on a laboratory coital model. Nearly 1000 (n=972) returned condoms made from natural rubber and polyurethane were examined. Visible features on those that were broken, were classified. Evidence combined from examining returns, questionnaire responses and the coital model strongly suggests a single predominant mechanism of failure we named "blunt puncture," where the tip of the thrusting male penis progressively stretches one part of the intact condom wall until it ultimately breaks. Blunt puncture appears to be the mechanism of breakage responsible for more than 90% of condom breakage not attributable to misuse. Knowledge of the main mechanism of breakage should help develop better user instructions, better test methods and, ultimately, better condoms. (author's)
Language: English
Keywords:
GERMANY | RESEARCH REPORT | CONTRACEPTION RESEARCH | CONDOM FAILURE | LABORATORY PROCEDURES | SEXUAL INTERCOURSE | LUBRICANTS | TESTING | Europe, Central | Europe | Developed Countries | Contraception | Family Planning | Condoms | Barrier Methods | Contraceptive Methods | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Reproduction | Ingredients and Chemicals | Measurement | Research Methodology
Document Number: 325974

29.

Title: New options for barrier contraception.
Author: Yranski PA; Gamache ME
Source: Journal of Obstetric, Gynecologic, and Neonatal Nursing. 2008 May-Jun;37(3):384-389.
Abstract: Barrier contraceptives are a safe alternative to hormonal methods of fertility management. Newer barrier method options include the Today Sponge, the FemCap, and the Lea's Shield. Understanding the use, benefits, and limitations of these barrier methods of birth control will assist women's health care providers to better meet the family planning needs of their patients. (author's)
Language: English
Keywords:
GLOBAL | RESEARCH REPORT | LITERATURE REVIEW | BARRIER METHODS | VAGINAL BARRIER METHODS | VAGINAL SPONGE | VAGINAL SHIELD | CERVICAL CAP | CONTRACEPTIVE SAFETY | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTION RESEARCH | Contraceptive Methods | Contraception | Family Planning | Safety | Public Health | Health
Document Number: 326909

30.

Title: Can the female condom be used safely more than once?
Author: Family Health International [FHI]
Source: [Research Triangle Park, North Carolina], FHI, [2007]. [3] p. (FHI Research Briefs on the Female Condom No. 3)
Abstract: The female condom is more expensive than the male condom. If the female condom can be used safely more than once, the cost of each use would decline. Studies have found that the device remains structurally sound after repeated washings and reuse, and that a one-minute soak in a 1-to-20 dilution of bleach in water effectively inactivates the organisms that cause gonorrhea, chlamydia, herpes, and HIV infections. The World Health Organization (WHO) continues to recommend the use of a new male or female condom for every act of sexual intercourse where there is risk of an unplanned pregnancy or of acquiring a sexually transmitted infection, but WHO also stated in July 2002 that "the final decision on whether or not to support reuse of the female condom must ultimately be taken locally." Because some women may not have access to bleach, USAID supported additional research to assess the safety and feasibility of cleaning used female condoms with soap and water and eliminating the bleach disinfection step. One study, conducted by FHI, tested a solution of dish detergent and water based on volumes typically used to wash dishes: 7.5 milliliters of detergent per one liter of water, or about two squirts of detergent in a basin of water. It found that the dish detergent and water was just as effective as the 1:20 bleach solution in removing the organisms that cause gonorrhea, chlamydia, herpes and HIV infection from the surfaces of both new and pre-washed, relubricated condoms.
Language: English
Keywords:
GLOBAL | SUMMARY REPORT | FEMALE CONDOMS | WHO | CONTRACEPTION RESEARCH | CONTRACEPTIVE SAFETY | GENITAL EFFECTS, FEMALE | GENITAL EFFECTS, MALE | SEXUALLY TRANSMITTED DISEASE PREVENTION | Vaginal Barrier Methods | Barrier Methods | Contraceptive Methods | Contraception | Family Planning | UN | International Agencies | Organizations | Political Factors | Sociocultural Factors | Safety | Public Health | Health | Genitalia, Female | Genitalia | Urogenital System | Physiology | Biology | Genitalia, Male | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Diseases
Document Number: 331707


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