| 1. Title: Venous thromboembolism in women using hormonal contraceptives. Findings from the RIETE Registry. Author: Blanco-Molina A; Trujillo-Santos J; Tirado R; Canas I; Riera A; Valdes M; Monreal M Source: Thrombosis and Haemostasis. 2009;101(3):478-482. Abstract: There is scarce information on the clinical characteristics of contraceptive users who develop venous thromboembolism (VTE). RIETE is an ongoing registry of consecutive patients with symptomatic, objectively confirmed, acute VTE. We analyzed the clinical characteristics and additional risk factors for VTE in all enrolled women aged <50 years who were using or not using contraceptives at presentation with VTE. Of 1,667 women aged <50 years enrolled in RIETE as of December 2007, 593 (36%) were contraceptive users. Of 270 aged <25 years, 190 (70%) were users. Ninety-two contraceptive users (16%) had overweight, 89 (15%) were obese. Of 951 women with no additional risk factors for VTE (i.e. recent surgery, immobility or cancer) 457 (48%) were contraceptive users. Eighty-seven (15%) users had recent immobility for >/=4 days, 44 (7.4%) were postoperative. The most common reason for immobility was lower limb trauma not requiring surgery; 25% of users with recent immobility had received thromboprophylaxis. The most common type of surgery was non-major orthopaedic surgery. Twenty-one (48%) users with postoperative VTE had received prophylaxis. The percentage of users and non-users who tested positive for thrombophilia was similar. Contraceptive use remains the most frequent risk factor for VTE in women at fertile age. Identifying those at increased risk for VTE seems to be difficult. In the meanwhile, a higher use of thromboprophylaxis during immobility or minor surgery should be warranted. Language: English Keywords: SPAIN | RESEARCH REPORT | EPIDEMIOLOGIC METHODS | CLINICAL RESEARCH | WOMEN | PREVALENCE | THROMBOEMBOLISM | RISK FACTORS | CONTRACEPTIVE AGENTS, FEMALE | HORMONES | SIDE EFFECTS | COMPLICATIONS | SURGERY | POSTOPERATIVE PROCEDURES | Developed Countries | Europe, Southwestern | Europe | Research Methodology | Demographic Factors | Population | Measurement | Embolism | Vascular Diseases | Diseases | Health | Contraceptive Agents | Contraception | Family Planning | Endocrine System | Physiology | Biology | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 330607 |
2.  Title: Women's health and gender-based clinical trials on etoricoxib: methodological gender bias. Author: Chilet-Rosell E; Ruiz-Cantero MT; Horga JF Source: Journal of Public Health. 2009 Sep;31(3):434-45. Abstract: BACKGROUND: The aim of this study was to determine compliance with published good practice guidelines for gender and clinical trials using etoricoxib. The rationale for choosing etoricoxib was that it is widely used by women and there is evidence of potential interaction with contraceptives and hormone replacement therapy as highlighted in the product characteristics. METHODS: The study reviewed 58 etoricoxib published trials (54 papers) to determine if they met the gender recommendations of the Guidelines of Food and Drug Administration (1993) and the Sex, Gender and Pain Special Interest Group Consensus Working Group Report (2007). RESULTS: Women formed 70% of a total of 49 835 subjects included in the etoricoxib trials, but only 31% of the subjects were in Phase I. About 85.7% of trials did not show sex-stratified data. About 90.6 and 93.3% did not provide efficacy and adverse effects data by sex, respectively. There is scarce information about the influence of issues that specifically affect women. Discussion Women are under-represented in the published etoricoxib trials, specifically, in Phase I. Sex-stratified data on efficacy and adverse effects are scarce in etoricoxib trials. Together with the lack of data on women-specific issues, this suggests that etoricoxib may pose the same potential problems for women as other cyclooxygenase-2 inhibitors. Language: English Keywords: GLOBAL | LITERATURE REVIEW | CLINICAL TRIALS | DRUGS | ADMINISTRATION AND DOSAGE | DRUG INTERACTIONS | CONTRACEPTIVE AGENTS, FEMALE | HORMONE REPLACEMENT THERAPY | SIDE EFFECTS | THROMBOSIS | SEX FACTORS | PREGNANCY | VALIDITY | Clinical Research | Research Methodology | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents | Contraception | Family Planning | Thromboembolism | Embolism | Vascular Diseases | Diseases | Population Characteristics | Demographic Factors | Population | Reproduction | Measurement Document Number: 342950 |
| 3. Peer Reviewed Title: Contraceptive discontinuation and non-use in Santarem, Brazilian Amazon. Author: D'Antona Ade O; Chelekis JA; D'Antona MF; Siqueira AD Source: Cadernos De Saude Publica. 2009 Sep;25(9):2021-32. Abstract: In this paper we discuss the causes of non-adherence to reversible contraceptives, especially hormonal methods, among women in rural Santarem in the Brazilian Amazon. The analysis is based on questionnaires with 398 women and visits to health centers. We consider the motives reported by women who: never used contraception; used some method in the past; and who at the time of the survey were using a different method from the ones they used in the past. The results indicate a rejection of hormonal contraception and a preference for female sterilization, an option possibly influenced by the characteristics of health services in the region. The side effects of hormonal contraceptive use reported by part of the interviewees contribute to a generalized fear of the side effects even among women who have never used such methods. To improve women's health services in the Amazon, we recommend further studies of the relationship between reported side effects and available services and prescriptions, as well as an analysis of women's discourse and perceptions. Language: English Keywords: BRAZIL | RURAL AREAS | RESEARCH REPORT | WOMEN | CONTRACEPTION TERMINATION | CONTRACEPTIVE METHODS CHOSEN | MOTIVATION | CONTRACEPTIVE AGENTS, FEMALE | CONTRACEPTIVE AGENTS, SIDE EFFECTS | FEAR | FEMALE STERILIZATION | CONDOM USE | CONTRACEPTIVE PREVALENCE | PROGRAM ACCESSIBILITY | South America, Eastern | South America | Latin America | Americas | Developing Countries | Geographic Factors | Population | Demographic Factors | Contraception | Family Planning | Contraceptive Usage | Psychological Factors | Behavior | Contraceptive Agents | Emotions | Sterilization, Sexual | Risk Reduction Behavior | Program Evaluation | Programs | Organization and Administration Document Number: 342777 |
| 4. Title: Thrombophilic conditions in the adolescent: the gynecologic impact. Author: Dietrich JE; Yee DL Source: Obstetrics and Gynecology Clinics of North America. 2009 Mar;36(1):163-75. Abstract: As Virchow's triad suggests, a fine balance exists between the vascular wall, intravascular contents, and dynamic blood flow, such that a shift in this balance predisposes to thrombosis. Although thromboembolic events (TEs) are relatively infrequent in adolescents, the morbidity and mortality associated with TEs can be significant. Over the past 15 years, TEs and inherited and acquired thrombophilic conditions underlying them have become increasingly recognized in teens at risk, with combined hormonal contraception constituting one of the most significant of these risk factors. Therefore, managing gynecologic problems in teens who have thrombophilic conditions can be challenging. It is important to have a clear understanding about safe options available to help address adolescent gynecologic concerns in this setting and to manage situations collaboratively with a hematologist. Language: English Keywords: UNITED STATES OF AMERICA | RECOMMENDATIONS | ADOLESCENTS, FEMALE | GYNECOLOGY | THROMBOSIS | RISK FACTORS | HEREDITARY DISEASES | CONTRACEPTIVE AGENTS, FEMALE | ORAL CONTRACEPTIVES, COMBINED | BLOOD COAGULATION EFFECTS | SCREENING | PROGESTERONE | CONTRACEPTIVE METHODS | Developed Countries | North America | Americas | Adolescents | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Medicine | Health Services | Delivery of Health Care | Health | Thromboembolism | Embolism | Vascular Diseases | Diseases | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Hematological Effects | Hemic System | Physiology | Biology | Examinations and Diagnoses | Medical Procedures | Progestational Hormones | Hormones | Endocrine System Document Number: 342856 |
| 5. Title: Contraception and HIV infection in women. Author: Heikinheimo O; Lahteenmaki P Source: Human Reproduction Update. 2009 Mar-Apr;15(2):165-76. Abstract: BACKGROUND: More than 15 million women, many of reproductive age, were infected with human immunodeficiency virus (HIV) at the end of 2007. As the HIV epidemic evolves, heterosexual intercourse is increasingly risky: the risk of infection in exposed young women is 4- to 7-fold higher than in young men and nearly half a million newborns annually have HIV. This review aims to show the effect of contraceptive choices on risk of HIV and on the course of disease in women with HIV. METHODS: Relevant citations were selected by agreement between the authors after a search of MEDLINE using the terms HIV/AIDS and contraception. RESULTS: Risk of transmission of HIV varies from 1 in 200 to 1 in 10 000 coital incidents, depending in part on the integrity of the vaginal epithelium. Consistent use of male condoms has been proven to reduce horizontal transmission of HIV by 80% among HIV-serodiscordant couples. Hormonal contraception may increase the risk of HIV acquisition in high-risk women such as commercial sex workers, but not in women at low risk of HIV. While hormonal contraception did not affect progression of disease in two cohort studies involving 370 women, in a randomized trial among women not receiving antiretroviral medication, clinical disease accelerated in the oral contraception group (13.2/100 woman-years) compared with the copper intrauterine devices group (8.6/100 woman-years; hazard ratio, 1.5; 95% confidence interval, 1.04-2.1). Hormonal contraception does not interfere with antiviral drug effectiveness. CONCLUSIONS: All the available reversible contraceptive methods can generally be used by women at risk of HIV infection and by HIV-infected women. Further studies are needed to investigate the safety and efficiency of hormonal contraception in women living with HIV/AIDS. Language: English Keywords: FINLAND | LITERATURE REVIEW | EPIDEMIOLOGIC METHODS | CLINICAL RESEARCH | WOMEN | PERSONS LIVING WITH HIV/AIDS | PREVALENCE | HIV INFECTIONS | CONDOM USE | CONTRACEPTIVE AGENTS, FEMALE | HORMONES | IUD, COPPER RELEASING | ANTIVIRAL DRUGS | DRUG INTERACTIONS | Developed Countries | Europe, Northern | Europe | Research Methodology | Demographic Factors | Population | Viral Diseases | Diseases | Measurement | Risk Reduction Behavior | Behavior | Contraceptive Agents | Contraception | Family Planning | Endocrine System | Physiology | Biology | IUD | Contraceptive Methods | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 330966 |
| 6. Title: The spermostatic and microbicidal actions of quinones and maleimides: towards a dual purpose contraceptive agent. Author: Hughes LM; Griffith R; Carey A; Butler T; Donne SW; Beagley KW; Aitken RJ Source: Molecular Pharmacology. 2009 Mar 31; Abstract: There is an urgent need to develop safe, effective dual-purpose contraceptive agents that combine the prevention of pregnancy with protection against sexually transmitted disease. Here we report the identification of a group of compounds that on contact with human spermatozoa induce a state of 'spermostasis', characterized by the extremely rapid inhibition of sperm movement without compromising cell viability. These spermostatic agents were more active and significantly less toxic than the reagent in current clinical use, nonoxynol 9, giving therapeutic indices (ratio of spermostatic to cytotoxic activity) that were orders of magnitude greater than this traditional spermicide. Although certain compounds could trigger reactive oxygen species generation by spermatozoa, this activity was not correlated with spermostasis. Rather, the latter was associated with alkylation of two major sperm tail proteins that were identified as A Kinase Anchoring Proteins (AKAP3 and AKAP4) by mass spectrometry. As a consequence of disrupted AKAP function, the abilities of cAMP to drive PKA-dependent activities in the sperm tail such as the activation of SRC and the consequent stimulation of tyrosine phosphorylation, were suppressed. Furthermore, analysis of microbicidal activity using Chlamydia, revealed powerful inhibitory effects at the same low micromolar doses that suppressed sperm movement. In this case, the microbicidal action was associated with alkylation of MOMP, a major Chlamydial membrane protein. Taken together, these results have identified for the first time a novel set of cellular targets and chemical principles capable of providing simultaneous defense against both fertility and the spread of sexually transmitted disease. Language: English Keywords: AUSTRALIA | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN | MICROBICIDES | SPERM IMMOBILIZING AGENTS | CONTRACEPTIVE AGENTS, FEMALE | SEXUALLY TRANSMITTED DISEASE PREVENTION | NONOXYNOL-9 | SPERMICIDAL CONTRACEPTIVE AGENTS | Oceania | Developed Countries | Research Methodology | Demographic Factors | Population | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents | Contraception | Family Planning | Sexually Transmitted Diseases | Reproductive Tract Infections | Infections | Diseases Document Number: 330928 |
| 7. Peer Reviewed Title: Contraceptive use in women enrolled into preventive HIV vaccine trials: experience from a phase I/II trial in East Africa. Author: Kibuuka H; Guwatudde D; Kimutai R; Maganga L; Maboko L; Watyema C; Sawe F; Shaffer D; Matsiko D; Millard M; Michael N; Wabwire-Mangen F; Robb M Source: PLoS One. 2009;4(4):e5164. Abstract: BACKGROUND: HIV vaccine trials generally require that pregnant women are excluded from participation, and contraceptive methods must be used to prevent pregnancy during the trial. However, access to quality services and misconceptions associated with contraceptive methods may impact on their effective use in developing countries. We describe the pattern of contraceptive use in a multi-site phase I/IIa HIV Vaccine trial in East Africa (Uganda, Kenya and Tanzania) and factors that may have influenced their use during the trial. METHODS: Pregnancy prevention counseling was provided to female participants during informed consent process and at each study visit. Participants' methods of contraception used were documented. Methods of contraceptives were provided on site. Pregnancy testing was done at designated visits during the trial. Obstacles to contraceptive use were identified and addressed at each visit. RESULTS: Overall, 103 (31.8%) of a total of 324 enrolled volunteers were females. Female participants were generally young with a mean age of 29(+/-7.2), married (49.5%) and had less than high school education (62.1%). Hormonal contraceptives were the most common method of contraception (58.3%) followed by condom use (22.3%). The distribution of methods of contraception among the three sites was similar except for more condom use and less abstinence in Uganda. The majority of women (85.4%) reported to contraceptive use prior to screening. The reasons for not using contraception included access to quality services, insufficient knowledge of certain methods, and misconceptions. CONCLUSION: Although hormonal contraceptives were frequently used by females participating in the vaccine trial, misconceptions and their incorrect use might have led to inconsistent use resulting in undesired pregnancies. The study underscores the need for an integrated approach to pregnancy prevention counseling during HIV vaccine trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT00123968. Language: English Keywords: AFRICA, SUB SAHARAN | RESEARCH REPORT | CLINICAL TRIALS | CONTRACEPTIVE PREVALENCE SURVEYS | WOMEN IN DEVELOPMENT | VACCINES | CONTRACEPTIVE USAGE | HIV PREVENTION | CONTRACEPTIVE AGENTS, FEMALE | CONDOM USE | CONTRACEPTIVE PREVALENCE | ABSTINENCE | KNOWLEDGE | PROGRAM ACCESSIBILITY | Africa | Developing Countries | Clinical Research | Research Methodology | Family Planning Surveys | Family Planning | Economic Development | Economic Factors | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraception | HIV Infections | Viral Diseases | Diseases | Contraceptive Agents | Risk Reduction Behavior | Behavior | Family Planning, Behavioral Methods | Sociocultural Factors | Program Evaluation | Programs | Organization and Administration Document Number: 330944 |
| 8. Peer Reviewed Title: Confronting the legal risks of prescribing the contraceptive patch with ongoing litigation. Author: Phelps JY; Kelver ME Source: Obstetrics and Gynecology. 2009 Mar;113(3):712-6. Abstract: Recent changes in U.S. Food and Drug Administration (FDA) labeling and news reports of lawsuits resulting in million-dollar settlements understandably may deter gynecologists from prescribing the transdermal contraceptive patch Ortho Evra (Ortho-McNeil Pharmaceutical, Inc., Titusville, NJ). Gynecologists who, with all good intentions, prescribe an FDA-approved drug such as the contraceptive patch potentially could find themselves liable for an adverse drug reaction. Although much of the current focus by plaintiff attorneys and the news media is on the contraceptive patch, no prescription contraceptive method is without medical risks to the patient or legal risks to the prescribing gynecologist. The purpose of this commentary is to provide an overview of the medical-legal controversies and pitfalls in prescribing the contraceptive patch as well as to outline how gynecologists can avert legal liability by providing proper informed consent. Despite FDA labeling changes and ongoing litigation, with proper informed consent, the contraceptive patch still may be the best choice for many patients who prefer the convenience of a weekly patch over a daily oral contraceptive. Also, regardless of the contraceptive option chosen, the principles of providing and documenting proper informed consent in medical records are applicable not only to providing quality care to patients, but also to protecting the legal interests of the prescribing gynecologist. By documenting proper informed consent in medical records, gynecologists should feel more at ease in prescribing the contraceptive method that best fits their individual patients' needs, even in the presence of ongoing litigation. Language: English Keywords: UNITED STATES OF AMERICA | CRITIQUE | RECOMMENDATIONS | EVALUATION | PHYSICIANS | LITIGATION | RISK ASSESSMENT | PRESCRIPTIONS | CONTRACEPTIVE AGENTS, FEMALE | ADMINISTRATION AND DOSAGE | USFDA | SIDE EFFECTS | INFORMED CONSENT | RECORDS | Developed Countries | North America | Americas | Health Personnel | Delivery of Health Care | Health | Political Factors | Sociocultural Factors | Distributional Activities | Program Activities | Programs | Organization and Administration | Contraceptive Agents | Contraception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | USPHS | Government Agencies | Organizations | Information Processing | Information Document Number: 330700 |
9.  Title: The potential role of contraceptive implants in sub-Saharan Africa. Author: Family Health International [FHI] Source: [Research Triangle Park, North Carolina], FHI, [2008]. [2] p. (Research Brief on Hormonal Contraception) Abstract: A study by investigators at Family Health International and University College London suggests that a large number of unintended pregnancies in sub-Saharan Africa could be averted if even a fraction of women who use short-term hormonal contraceptives (pills and injectables) would switch to contraceptive implants. Language: English Keywords: AFRICA, SUB SAHARAN | SUMMARY REPORT | THEORETICAL MODELS | CONTRACEPTIVE IMPLANTS | PREGNANCY, UNPLANNED | CONTRACEPTIVE AGENTS, FEMALE | CONTRACEPTION TERMINATION | CONTRACEPTION FAILURE | CONTRACEPTIVE METHOD SWITCHING | Africa | Developing Countries | Research Methodology | Contraceptive Methods | Contraception | Family Planning | Reproductive Behavior | Fertility | Population Dynamics | Demographic Factors | Population | Contraceptive Agents | Contraceptive Usage Document Number: 331723 |
| 10. Title: Hormonal contraception: present and future. Author: Benagiano G; Bastianelli C; Farris M Source: Drugs of today. 2008 Dec;44(12):905-23. Abstract: The original form of hormonal contraception ("the Pill") has developed into a variety of modalities administered through different routes: oral, intramuscular, subcutaneous, transdermal, intrauterine or intravaginal, and intranasal (abandoned). At present, two separate methods of hormonal contraception exist; one is used to prevent fertilization and the other to prevent pregnancy. From a pharmacological point of view, hormonal methods utilize either a combination of estrogen and progestin or progestin alone. Today all combined methods contain ethynylestradiol, and over the years there has been a substantial reduction in its dosage from almost 80 microg to as low as 15 microg. On the other hand, a variety of progestins are currently utilized that belong to two main chemical families: derivatives of progesterone and derivatives of 19-nortestosterone or gonane. These compounds, developed over a period of 50 years, can be distinguished in four successive "generations". Recent developments include new oral regimens intended to change the 7-day medication-free interval and new commercial preparations; the latter utilize the progestins drospirenone and dienogest. In addition, an oral contraceptive containing chlormadinone has also been marketed. Besides the oral route, contraceptive systems exist or are under development that employ the intramuscular, transdermal and intravaginal routes; they deliver both an estrogen and a progestin. Several patches and vaginal rings are also marketed. A variety of long-acting methods delivering only a progestin are also available. They use the subcutaneous route or are released from an intrauterine system, both of which provide optimal contraceptive protection and, depending on the system, can last up to 5 years (and probably more). Finally, progestin-releasing vaginal rings are under investigation. The second type of hormonal contraception, called "emergency contraception", utilizes progestins and antiprogestins and to be effective should be taken as soon as possible after unprotected intercourse. Language: English Keywords: ITALY | HISTORICAL REVIEW | CONTRACEPTIVE AGENTS, FEMALE | CONTRACEPTIVE METHODS | CONTRACEPTIVE MODE OF ACTION | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | EMERGENCY CONTRACEPTION | MENSTRUATION | Developed Countries | Europe, Southern | Europe | Contraceptive Agents | Contraception | Family Planning | Reproduction Document Number: 330078 |
| 11. Peer Reviewed Title: Hormonal contraception. Author: Blumenthal PD; Edelman A Source: Obstetrics and Gynecology. 2008 Sep;112(3):670-84. Abstract: Hormonal contraceptives have been a part of clinical practice for more than 40 years, and family planning programs, based largely on contraceptive provision, are regarded as one of the most successful public health interventions of the 20th century. Thus, discussion of family planning issues and contraceptive considerations has become an integral component of women's health care and one of the benchmarks of the traditional annual well-women visit. In terms of cost-effectiveness, prevention of unplanned pregnancies through contraceptive use has repeatedly been shown to be a highly cost-effective use of health care dollars. Options for effective hormonal contraception have expanded tremendously and include a variety of delivery options, including the pills both in traditional 21/7 format, and more recently in a 24/4 format, as well as a vaginal ring, a skin patch, implants, and the hormonally medicated intrauterine device. Importantly, the overall risks associated with hormonal contraceptives have been reduced as compared with older formulations, even for women with medical conditions. Many modern hormonal contraceptives also offer valuable noncontraceptive benefits. To help clinical decision making, a number of evidence-based guides have been published, and the American College of Obstetricians and Gynecologists has recently updated their practice bulletin on contraception use in women with medical conditions. In general, clinical protocols for provision of hormonal contraceptives have been streamlined, and unnecessary practices, tests, and procedures are identified and discouraged. In this review, we will summarize both technical and programmatic aspects of hormonal contraceptive use, and methods are discussed in order of efficacy from highest to lowest. Language: English Keywords: UNITED STATES OF AMERICA | CRITIQUE | RECOMMENDATIONS | LITERATURE REVIEW | CLINICAL RESEARCH | WOMEN | PREVENTIVE HEALTH CARE | COST EFFECTIVENESS | CONTRACEPTIVE METHODS | CONTRACEPTIVE SAFETY | CONTRACEPTIVE AGENTS, SIDE EFFECTS | MAGAZINES | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTIVE AGENTS, FEMALE | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Health Services | Delivery of Health Care | Health | Evaluation Indexes | Quantitative Evaluation | Evaluation | Contraception | Family Planning | Safety | Public Health | Contraceptive Agents | Printed Media | Mass Media | Communication Document Number: 329050 |
| 12. Peer Reviewed Title: Tolerability and clinical safety of Implanon. Author: Blumenthal PD; Gemzell-Danielsson K; Marintcheva-Petrova M Source: European Journal of Contraception and Reproductive Health Care. 2008 Jun;13 Suppl 1:29-36. Abstract: The objectives were to evaluate the tolerability and clinical safety of the subdermal, long-acting hormonal contraceptive Implanon. This integrated safety analysis included 11 international studies concerning Implanon (68 mg etonogestrel) of which 10 had a duration of at least two years. Assessments included reports of adverse events (AEs), reasons and rates of discontinuation, insertion/removal complications, and the condition of the implant site. Metabolic and coagulation parameters are briefly discussed to fully describe the clinical safety profile. In total 942 women were exposed to Implanon for 24,679 cycles over the course of one to five years. The overall discontinuation rate was 32.7%; the most frequently reported reasons for discontinuation were adverse events (13.9%), bleeding irregularities (10.4%), and planning pregnancy (4.1%). The most commonly reported drug-related AE was headache (15.3%); however, headache was reported in only 1.6% of women as a reason for discontinuation. Insertion and removal times for Implanon were short with few complications, none of which were major. From earlier studies it is known that treatment with Implanon has little effect on metabolic and coagulation parameters. Implanon is a well-tolerated and safe method of long-acting hormonal contraception for women. (author's) Language: English Keywords: GLOBAL | RESEARCH REPORT | LITERATURE REVIEW | CLINICAL TRIALS | CONTRACEPTIVE IMPLANTS | CONTRACEPTIVE AGENTS, FEMALE | CONTRACEPTIVE AGENTS, PROGESTIN | CONTRACEPTIVE AGENTS, SIDE EFFECTS | CONTRACEPTIVE SAFETY | CONTRACEPTIVE METHOD ACCEPTABILITY | CONTRACEPTION CONTINUATION | Clinical Research | Research Methodology | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents | Safety | Public Health | Health | Contraceptive Usage Document Number: 325041 |
| 13. Peer Reviewed Title: Abnormal vaginal bleeding in women of reproductive age: A descriptive study of initial management in general practice. Author: de Vries CJ; Wieringa-de Waard M; Vervoort CL; Ankum WM; Bindels PJ Source: BMC Women's Health. 2008 Apr 15;8:7. Abstract: Abnormal vaginal bleeding (AVB) in women of reproductive age is a common reason for consulting a general practitioner. Nevertheless, how general practitioners (GPs) choose to initially manage AVB is largely unknown, as is the prevalence of underlying pathology of AVB in primary care. To investigate the initial diagnostic procedures and treatment for AVB used in general practice, we performed a descriptive study based on computerised medical records. New consultations for AVB in 2000 and 2001 were selected. Patient characteristics, diagnostic procedures and treatment were analysed. In total, 270 new consultations were included. The majority of patients (75%) consulted the GP for AVB only once. GPs performed diagnostic procedures in 54% of all consultations. Overall, additional diagnostic procedures revealed abnormalities in 11% of women. However, the diagnostic procedures implemented by the GPs varied widely per bleeding type and contraceptive use. Anaemia was found in 36% of 45 women tested. Uterine fibroids were found in 41% of 27 women examined by ultrasound. Medication was prescribed in 34% of all consultations. A gynaecological referral was registered in 4% of all contacts. Initially, GPs tend to follow a policy of expectant management in women of reproductive age with AVB. However, when additional diagnostic procedures were performed, anaemia and uterine fibroids were found in a considerable number of women. (author's) Language: English Keywords: NETHERLANDS | RESEARCH REPORT | PROVIDERS WITH CLIENTS | MENORRHAGIA | METRORRHAGIA | PRIMARY HEALTH CARE | EXAMINATIONS AND DIAGNOSES | TREATMENT | CONTRACEPTIVE AGENTS, FEMALE | REFERRAL AND CONSULTATION | Developed Countries | Europe, Western | Europe | Health Services | Delivery of Health Care | Health | Menstruation Disorders | Diseases | Bleeding | Signs and Symptoms | Medical Procedures | Medicine | Contraceptive Agents | Contraception | Family Planning | Program Activities | Programs | Organization and Administration Document Number: 326126 |
| 14. Title: The latest advances in hormonal contraception. Author: Fontenot HB; Harris AL Source: Journal of Obstetric, Gynecologic, and Neonatal Nursing. 2008 May-Jun;37(3):369-374. Abstract: Millions of women each year start or continue to use some type of hormonal contraceptive method. Choosing a method may be anxiety provoking. In this article, we review some of the latest advances in and options for hormonal contraception, including extended-dose oral contraceptives, the vaginal ring, injectable methods, and emergency contraception. Nurses can facilitate women's decision making for healthy reproductive options. (author's) Language: English Keywords: GLOBAL | RESEARCH REPORT | LITERATURE REVIEW | CONTRACEPTIVE AGENTS, FEMALE | CONTRACEPTIVE AGENTS, ESTROGEN | CONTRACEPTIVE AGENTS, PROGESTIN | ORAL CONTRACEPTIVES | ORAL CONTRACEPTIVES, LOW-DOSE | VAGINAL RING | EMERGENCY CONTRACEPTION | INJECTABLES | DEPO-PROVERA | ORAL CONTRACEPTIVES, CONTRAINDICATIONS | ORAL CONTRACEPTIVES, SIDE EFFECTS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | Contraceptive Agents | Contraception | Family Planning | Contraceptive Methods | Medroxyprogesterone Acetate | Contraceptive Safety | Safety | Public Health | Health Document Number: 326908 |
| 15. Peer Reviewed Title: The contraceptive efficacy of Implanon: a review of clinical trials and marketing experience. Author: Graesslin O; Korver T Source: European Journal of Contraception and Reproductive Health Care. 2008 Jun;13 Suppl 1:4-12. Abstract: The objectives were to evaluate the contraceptive efficacy of the etonogestrel-releasing implant Implanon as assessed in international studies and during nine years of marketing experience. The analysis included 11 international studies and data collected during nine years of marketing experience (1998-2007). Seven of these studies were noncomparative; the four other studies included the 6-rod levonorgestrel implant system or an intrauterine device as a comparator. All studies except one were of at least two years in duration, and all had contraceptive efficacy as the objective. Market data were provided unsolicited to Organon, part of Schering Plough. The integrated efficacy analysis included 923 non-breastfeeding women who were exposed to the implant for 24,100 cycles. No in-treatment or pretreatment pregnancies were reported. Fifty post-treatment pregnancies were reported, six of which occurred within 14 days of implant removal, indicating that fertility had quickly returned. Over a nine-year marketing period an overall pregnancy rate of 0.049 per 100 implants sold (estimated Pearl Index = 0.031 based on all pregnancies reported) was calculated. When only counting contraceptive method failures the pregnancy rate amounts to 0.010 per 100 implants sold (estimated Pearl Index = 0.006). Implanon is a highly effective and quickly reversible subdermal method of long-acting hormonal contraception for women. Typical use of this implant achieves a contraceptive protection exceeding 99%. (author's) Language: English Keywords: GLOBAL | RESEARCH REPORT | LITERATURE REVIEW | CLINICAL TRIALS | CONTRACEPTIVE IMPLANTS | CONTRACEPTIVE AGENTS, FEMALE | CONTRACEPTIVE AGENTS, PROGESTIN | CONTRACEPTIVE EFFECTIVENESS | Clinical Research | Research Methodology | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents Document Number: 325039 |
| 16. Peer Reviewed Title: Hormonal contraception and the risks of STI acquisition: Results of a feasibility study to plan a future randomized trial. Author: Hubacher D; Raymond ER; Beksinska M; Delany-Moretlwe S; Smit J Source: Contraception. 2008 May;77(5):366-370. Abstract: Because of limitations in observational studies, a randomized controlled trial (RCT) would help clarify whether hormonal contraception increases the risks of acquiring a sexually transmitted infection (STI). However, the feasibility of such a trial is uncertain. We conducted a study to assess the feasibility of conducting a RCT that would compare the acquisition risk for Chlamydia trachomatis and Neisseria gonorrhoeae in women randomized to an intrauterine device (IUD) or depot medroxyprogesterone acetate (DMPA). In our cross-sectional survey conducted at three clinics, we gave information on a potential RCT to clients, asked them questions to assess comprehensibility and finally asked respondents whether they would consider enrolling in such a trial. In addition, the 190 participants provided urine or endocervical swab specimens so we could estimate the prevalence of STIs. Overall, 70% of participants stated that they would take part in a future trial and accept randomization to either the IUD orDMPA. Participant understanding of the trial requirements was high. Twenty-nine percent of the participants were infected with either N. gonorrhoeae or C. trachomatis. With a high prevalence of STI in this population and the apparent willingness of appropriate candidates to participate, an RCT to measure risks of incident STI infection from hormonal contraception appears feasible. (author's) Language: English Keywords: SOUTH AFRICA | RESEARCH REPORT | CLINICAL RESEARCH | PILOT PROJECTS | SURVEYS | CROSS SECTIONAL ANALYSIS | WOMEN | CONTRACEPTIVE AGENTS, FEMALE | SEXUALLY TRANSMITTED DISEASES | DEPO-PROVERA | IUD | GONORRHEA | CHLAMYDIA | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Research Methodology | Studies | Sampling Studies | Demographic Factors | Population | Contraceptive Agents | Contraception | Family Planning | Reproductive Tract Infections | Infections | Diseases | Medroxyprogesterone Acetate | Contraceptive Agents, Progestin | Contraceptive Methods Document Number: 325855 |
| 17. Peer Reviewed Title: Adolescent females and hormonal contraception: A retrospective study in primary care. Author: Krishnamoorthy N; Simpson CD; Townend J; Helms PJ; McLay JS Source: Journal of Adolescent Health. 2008;42(1):97-101. Abstract: The aim of this study was to assess change in the number of adolescent females prescribed hormonal contraception in primary care following the publication in the United Kingdom of the Social Exclusion Unit report on Teenage Pregnancy. We conducted a retrospective observational study of 320 primary care practices in Scotland. Hormonal contraceptive prescribing to girls aged less than 16 years and those aged 16-19 years was assessed for April 1 to March 31 for the study years 2000-2001 to 2005-2006 from Scottish primary care practice data. Between 2000-2001 and 2005-2006, the proportion of girls aged less than 16 years and those 16-19 years who were prescribed hormonal contraception by their primary care physicians increased by 82% (p less than .001) and 53% (p less than .001) respectively. The increase became significant from age 12 years for the combined oral contraceptive, 14 years for the progestogen-only pill, and 15 years for depot progestogens. By 2005-2006, 2.9% of girls aged less than 16 years and 40.5% of those aged 16-19 years were prescribed some form of hormonal contraception by their primary care physicians. The small number of girls aged less than 12 years who were prescribed hormonal contraception remained constant over the study period. Since the publication in the United Kingdom of the Social Exclusion Unit Report on Teenage Pregnancy, there has been a significant increase in the number of female adolescents aged greater than or equal to 12 years prescribed hormonal contraception by their primary care physicians. However the number of individuals prescribed hormonal contraception still remains relatively low in comparison to the reported levels of sexual activity among adolescents in the United Kingdom. (author's) Language: English Keywords: UNITED KINGDOM | RESEARCH REPORT | RETROSPECTIVE STUDIES | ADOLESCENTS, FEMALE | PHYSICIANS | PRIMARY HEALTH CARE | CONTRACEPTIVE AGENTS, FEMALE | PRESCRIPTIONS | AGE FACTORS | PROGESTATIONAL HORMONES | SEX BEHAVIOR | ORAL CONTRACEPTIVES, COMBINED | ADOLESCENT PREGNANCY | PREVENTION AND CONTROL | Developed Countries | Europe, Western | Europe | Studies | Research Methodology | Adolescents | Youth | Population Characteristics | Demographic Factors | Population | Health Personnel | Delivery of Health Care | Health | Health Services | Contraceptive Agents | Contraception | Family Planning | Distributional Activities | Program Activities | Programs | Organization and Administration | Hormones | Endocrine System | Physiology | Biology | Behavior | Oral Contraceptives | Contraceptive Methods | Reproductive Behavior | Fertility | Population Dynamics | Diseases Document Number: 324963 |
| 18. Peer Reviewed Title: Non-Hodgkin lymphoma in women: reproductive factors and exogenous hormone use. Author: Lee JS; Bracci PM; Holly EA Source: American Journal of Epidemiology. 2008 Aug 1;168(3):278-88. Abstract: Few studies of reproductive hormone exposures and non-Hodgkin lymphoma (NHL) have examined NHL subtypes. Associations between reproductive hormonal factors and risk of all NHL and of two predominant subtypes, diffuse large-cell lymphoma (DLCL) (n = 233) and follicular lymphoma (n = 173), were investigated among women (n = 581) in a large, population-based, case-control study (1,591 cases, 2,515 controls). Controls (n = 836) identified by random digit dialing were frequency matched by age and county to incident NHL cases ascertained in the San Francisco Bay Area of California in 1988-1993. Adjusted unconditional logistic regression was used to obtain odds ratios. More than four pregnancies indicated a possible lower risk of all NHL (odds ratio (OR) = 0.81, 95% confidence interval (CI): 0.55, 1.2; p-trend = 0.06) and of DLCL (OR = 0.53, 95% CI: 0.31, 0.90; p-trend = 0.01). Exclusive use of menopausal hormone therapy for > or =5 years was associated with a reduced risk of all NHL (OR = 0.68, 95% CI: 0.48, 0.98) and of DLCL (OR = 0.50, 95% CI: 0.30, 0.85). Oral contraceptive use indicated a lower risk of all NHL (OR = 0.68, 95% CI: 0.49, 0.94), and perhaps DLCL (OR = 0.79, 95% CI: 0.51, 1.2), and of follicular lymphoma (OR = 0.75, 95% CI: 0.46, 1.2). Results suggest that endogenous and exogenous reproductive hormones confer different risks by NHL subtype and are associated with a reduced risk of DLCL in women. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CASE CONTROL STUDIES | QUESTIONNAIRES | WOMEN | CANCER | PREVENTION AND CONTROL | ESTROGENS | CONTRACEPTIVE AGENTS, FEMALE | ORAL CONTRACEPTIVES | ADMINISTRATION AND DOSAGE | HORMONE REPLACEMENT THERAPY | PREGNANCY | RISK FACTORS | Developed Countries | North America | Americas | Studies | Research Methodology | Demographic Factors | Population | Neoplasms | Diseases | Hormones | Endocrine System | Physiology | Biology | Contraceptive Agents | Contraception | Family Planning | Contraceptive Methods | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Reproduction Document Number: 328352 |
| 19. Title: Immediate start of hormonal contraceptives for contraception (Review). Author: Lopez LM; Newmann SJ; Grimes DA; Nanda K; Schulz KF Source: Cochrane Database of Systematic Reviews. 2008;(2):1-31. ID:CD006260 Abstract: Health care providers often tell women to wait until the next menses to begin hormonal contraception. The main intent is to avoid contraceptive use during an undetected pregnancy. An alternative is to start hormonal contraception immediately with back-up birth control for the first seven days. Immediate initiation was first introduced with combined oral contraceptives (COCs), and has expanded to other hormonal contraceptives. How immediate start compares to conventional menses-dependent start is unclear regarding effectiveness, continuation, and acceptability. The immediate-start approach may improve women's access to, and continuation of, hormonal contraception. This review examined randomized controlled trials of immediate-start hormonal contraception for differences in effectiveness, continuation, and acceptability. We searched MEDLINE, CENTRAL, POPLINE, EMBASE, and LILACS for trials of immediate-start hormonal contraceptives. We contacted researchers to find other studies. We included randomized controlled trials that compared immediate start to conventional start of hormonal contraception. Also included were trials that compared immediate start of different hormonal contraceptive methods with each other. Data were abstracted by two authors and entered into RevMan. The Peto odds ratio (OR) with 95% confidence interval (CI) was calculated. Five studies were included. Method discontinuation was similar between groups in all trials. Bleeding patterns and side effects were similar in trials that compared immediate with conventional start. In a study of depot medroxyprogesterone acetate (DMPA), immediate start of DMPA showed fewer pregnancies than a 'bridge' method before DMPA (OR 0.36; 95% CI 0.16 to 0.84). Further, more women in the immediate-DMPA group were very satisfied versus those with a 'bridge' method (OR 1.99; 95% CI 1.05 to 3.77). A trial of two immediate-start methods showed the vaginal ring group had less prolonged bleeding (OR 0.42; 95% CI 0.20 to 0.89) and less frequent bleeding (OR 0.23; 95% CI 0.05 to 1.03) than COC users. The ring group also reported fewer side effects. For satisfaction, more immediate ring users were very satisfied than immediate COC users (OR 2.88; 95% CI 1.59 to 5.22). We found limited evidence that immediate start of hormonal contraception reduces unintended pregnancies or increases method continuation. However, the pregnancy rate was lower with immediate start of DMPA versus another method. Some differences were associated with contraceptive type rather than initiation method, that is, immediate ring versus immediate COC. More studies are needed of immediate versus conventional start of the same hormonal contraceptive. (author's) Language: English Keywords: GLOBAL | RESEARCH REPORT | LITERATURE REVIEW | CLINICAL TRIALS | CONTRACEPTIVE AGENTS, FEMALE | TIME FACTORS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | CONTRACEPTIVE SAFETY | CONTRACEPTIVE EFFECTIVENESS | CONTRACEPTION CONTINUATION | USER COMPLIANCE | Clinical Research | Research Methodology | Contraceptive Agents | Contraception | Family Planning | Population Dynamics | Demographic Factors | Population | Safety | Public Health | Health | Contraceptive Usage | Behavior Document Number: 326423 |
| 20. Peer Reviewed Title: The effects of Implanon on menstrual bleeding patterns. Author: Mansour D; Korver T; Marintcheva-Petrova M; Fraser IS Source: European Journal of Contraception and Reproductive Health Care. 2008 Jun;13 Suppl 1:13-28. Abstract: The objectives were to evaluate an integrated analysis of bleeding patterns associated with use of the subdermal contraceptive implant Implanon (etonogestrel, Organon, part of Schering-Plough) and to provide physician guidance to optimize patient counselling. Data from 11 clinical trials were reviewed (N = 923). Assessments included bleeding-spotting records, dysmenorrhoea, and patient-perceived reasons for discontinuation. Bleeding patterns were analysed via reference period (RP) analyses. Implanon use was associated with the following bleeding irregularities: amenorrhoea (22.2%) and infrequent (33.6%), frequent (6.7%), and/or prolonged bleeding (17.7%). In 75% of RPs, bleeding-spotting days were fewer than or comparable to those observed during the natural cycle, but they occurred at unpredictable intervals. The bleeding pattern experienced during the initial phase predicted future patterns for the majority of women. The group of women with favourable bleeding patterns during the first three months tended to continue with this pattern throughout the first two years of use, whereas the group with unfavourable initial patterns had at least a 50% chance that the pattern would improve. Only 11.3% of patients discontinued owing to bleeding irregularities, mainly because of prolonged flow and frequent irregular bleeding. Most women (77%) who had baseline dysmenorrhoea experienced complete resolution of symptoms. Implanon use is associated with an unpredictable bleeding pattern, which includes amenorrhoea and infrequent, frequent, and/or prolonged bleeding. The bleeding pattern experienced during the first three months is broadly predictive of future bleeding patterns for many women. Effective preinsertion counselling on the possible changes in bleeding patterns may improve continuation rates. (author's) Language: English Keywords: GLOBAL | RESEARCH REPORT | LITERATURE REVIEW | CLINICAL TRIALS | CONTRACEPTIVE IMPLANTS | CONTRACEPTIVE AGENTS, FEMALE | CONTRACEPTIVE AGENTS, PROGESTIN | MENSTRUATION | MENSTRUATION DISORDERS | BLEEDING | CONTRACEPTIVE AGENTS, SIDE EFFECTS | CONTRACEPTION CONTINUATION | Clinical Research | Research Methodology | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents | Reproduction | Diseases | Signs and Symptoms | Contraceptive Usage Document Number: 325040 |
| 21. Peer Reviewed Title: Real-world patterns of prescription refills for branded hormonal contraceptives: a reflection of contraceptive discontinuation. Author: Nelson AL; Westhoff C; Schnare SM Source: Obstetrics and Gynecology. 2008 Oct;112(4):782-7. Abstract: OBJECTIVE: The objective was to describe timely refills of hormonal contraceptive products among a large, geographically diverse population of U.S. women as an estimate of method continuation over time. METHODS: Longitudinal prescription refills from the Verispan database were collected from 99% of retail pharmacies in the United States between October 2003 and August 2005 for specific branded hormonal contraceptives. We calculated refill rates for different contraceptive categories, for individual products, and for different age groups. RESULTS: Refill data were available for nearly 1.7 million women for 240 days and for almost 1 million women for 420 days. After 30 days, only 59.4-75.1% of women refilled their prescriptions for the various products on a timely basis. By 3 months, only 47.7-61.2% of women returned for timely refills. By 12 months, only 16.3-34.5% of women had consistently refilled their prescriptions. Very young women had refill rates for most methods that were at least as good as those of older women. CONCLUSION: These low rates of timely refill rates in actual practice indicate that few women had the potential for correct and consistent contraceptive use. New methods with extended cycles or a new progestin had higher rates than did other 28-day products. These high discontinuation rates suggest that barriers to successful utilization of contraceptives exist, and they highlight the need to routinely provide condoms and emergency contraception to women initiating hormonal contraception. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | ESTIMATION TECHNIQUES | LONGITUDINAL STUDIES | WOMEN | PRESCRIPTIONS | USER COMPLIANCE | CONTRACEPTIVE USAGE | CONTRACEPTIVE AGENTS, FEMALE | TIME FACTORS | AGE FACTORS | Developed Countries | North America | Americas | Research Methodology | Studies | Demographic Factors | Population | Distributional Activities | Program Activities | Programs | Organization and Administration | Behavior | Contraception | Family Planning | Contraceptive Agents | Population Dynamics | Population Characteristics Document Number: 329094 |
| 22. Title: New findings on contraceptives. Author: Ramchandran D; Salem RM Source: Population Reports. Series M: Special Topics. 2008 Jun;(20):1-20. Abstract: This report on new findings in contraception research can help program managers, providers, teachers, and communicators to: update colleagues and students on recent research findings; draw attention to the new, longer "grace period" for DMPA reinjection recently recommended by WHO, and advocate clear and prominent changes in program policy and training; answer concerns about ready access to emergency contraceptive pills; adopt and use checklists that qualify more women to use IUDs; recommend LAM to women with HIV who are breastfeeding; offer a wide range of contraceptive methods to women with HIV; check whether program guidelines reflect important research findings that have long been neglected in many places. (excerpt) Language: English Keywords: GLOBAL | TECHNICAL REPORT | CONTRACEPTION | CONTRACEPTIVE AGENTS, FEMALE | CONTRACEPTIVE AGENTS, PROGESTIN | INJECTABLES | EMERGENCY CONTRACEPTION | IUD | LACTATIONAL AMENORRHEA METHOD | ORAL CONTRACEPTIVES, COMBINED | OVARIAN CANCER | CERVICAL CANCER | HIV/FP INTEGRATION | Family Planning | Contraceptive Agents | Contraceptive Methods | Family Planning, Behavioral Methods | Oral Contraceptives | Cancer | Neoplasms | Diseases | Programs | Organization and Administration Document Number: 327555 |
| 23. Title: Hormonal contraception in HIV-positive women. Author: Womack J; Williams A Source: AIDS Reader. 2008 Jul;18(7):372-7, 381. Abstract: In September 2006, the CDC recommended that the interpretation of 'general consent' for medical care include HIV screening, which eliminated the need for a separate, written consent. Routine baseline prenatal screening should include an HIV test, with re-screening in the third trimester for women at high risk for HIV infection, including women with symptoms of acute HIV infection or women residing in a community with a high incidence of HIV infection among women of childbearing age (17 or more cases of HIV infection per 100,00 person-years). The goal of this recommendation is to increase identification of unrecognized HIV infection so as to expand the delivery and benefit of antiretroviral therapy and to decrease mother-to-child transmission. Because of these recommendations, providers can anticipate seeing an increased number of know HIV-positive persons in their practices. Furthermore, because women constitute the majority of persons younger than 25 years who are infected with HIV and because the number of HIV infections in women is increasing, it is likely that many of these patients will be young women. Control of fertility and the option of effective, reversible birth control will become more significant issues as these women choose to have families and to space rather than avoid pregnancies. Health care providers thus need to be well versed in the contraceptive options available to women and the clinical issues related to their use. Hormonal contraceptive methods are of particular interest to women of reproductive age because of their effectiveness. (excerpt) Language: English Keywords: UNITED STATES OF AMERICA | RECOMMENDATIONS | CRITIQUE | CLINICAL RESEARCH | WOMEN | PERSONS LIVING WITH HIV/AIDS | CONTRACEPTIVE AGENTS, FEMALE | HIV INFECTIONS | HIV TRANSMISSION | ANTIRETROVIRAL THERAPY | DRUG INTERACTIONS | GLUCOSE METABOLISM EFFECTS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | METABOLIC EFFECTS | LIPID METABOLIC EFFECTS | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Viral Diseases | Diseases | Contraceptive Agents | Contraception | Family Planning | HIV | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Carbohydrate Metabolic Effects | Physiology | Biology | Lipids Document Number: 328422 |
| 24. Peer Reviewed Title: Effect of depot medroxyprogesterone acetate on glucose tolerance in generalized lipodystrophy. Author: Yauger BJ; Gorden P; Park J; Cochran E; Stratton P Source: Obstetrics and Gynecology. 2008 Aug;112(2 Pt 2):445-7. Abstract: BACKGROUND: Lipodystrophy is a rare condition causing severe insulin resistance and frank diabetes. Depot medroxyprogesterone acetate (DMPA), a commonly used contraceptive, may worsen glucose tolerance in diabetics and those with lipodystrophy. CASE: A young woman with generalized lipodystrophy, who previously required greater than 1,000 units of insulin daily, had a normal hemoglobin A1c on leptin and metformin only. After an injection of DMPA, she developed severe hyperglycemia. Her levels returned to near normal only with extremely high doses of insulin (up to 1,700 units/d) and increased doses of leptin and metformin. CONCLUSION: Progestin-only contraceptives may detrimentally affect glucose tolerance, particularly in patients with lipodystrophy, a cause of severe insulin resistance and leptin deficiency. One DMPA injection appeared to profoundly alter glucose metabolism in this patient with frank diabetes resulting from lipodystrophy. The effect of progestin-only contraceptives on glucose tolerance should be monitored closely in any diabetic patient. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CONTRACEPTIVE AGENTS, FEMALE | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | COMPLICATIONS | DIABETES | CASE STUDIES | Developed Countries | North America | Americas | Contraceptive Agents | Contraception | Family Planning | Contraceptive Agents, Progestin | Diseases | Studies | Research Methodology Document Number: 328234 |
| 25. Peer Reviewed Title: Cervical cancer and hormonal contraceptives: Collaborative reanalysis of individual data for 16 573 women with cervical cancer and 35 509 women without cervical cancer from 24 epidemiological studies. Author: International Collaboration of Epidemiological Studies of Cervical Cancer Source: Lancet. 2007 Nov 10;370(9599):1609-1621. Abstract: Combined oral contraceptives are classified by the International Agency for Research on Cancer as a cause of cervical cancer. As the incidence of cervical cancer increases with age, the public-health implications of this association depend largely on the persistence of effects long after use of oral contraceptives has ceased. Information from 24 studies worldwide is pooled here to investigate the association between cervical carcinoma and pattern of oral contraceptive use. Individual data for 16 573 women with cervical cancer and 35 509 without cervical cancer were reanalysed centrally. Relative risks of cervical cancer were estimated by conditional logistic regression, stratifying by study, age, number of sexual partners, age at first intercourse, parity, smoking, and screening. Among current users of oral contraceptives the risk of invasive cervical cancer increased with increasing duration of use (relative risk for 5 or more years' use versus never use, 1.90 [95% CI 1.69-2.13]). The risk declined after use ceased, and by 10 or more years had returned to that of never users. A similar pattern of risk was seen both for invasive and in-situ cancer, and in women who tested positive for high-risk human papillomavirus. Relative risk did not vary substantially between women with different characteristics. The relative risk of cervical cancer is increased in current users of oral contraceptives and declines after use ceases. 10 years' use of oral contraceptives from around age 20 to 30 years is estimated to increase the cumulative incidence of invasive cervical cancer by age 50 from 7.3 to 8.3 per 1000 in less developed countries and from 3.8 to 4.5 per 1000 in more developed countries. (author's) Language: English Keywords: GLOBAL | LITERATURE REVIEW | EPIDEMIOLOGIC METHODS | WOMEN | WOMEN IN DEVELOPMENT | CERVICAL CANCER | CONTRACEPTIVE AGENTS, FEMALE | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | AGE FACTORS | RISK ASSESSMENT | CONTRACEPTIVE SAFETY | HPV | RISK FACTORS | Research Methodology | Demographic Factors | Population | Economic Development | Economic Factors | Cancer | Neoplasms | Diseases | Contraceptive Agents | Contraception | Family Planning | Oral Contraceptives | Contraceptive Methods | Safety | Public Health | Health | Population Characteristics | Evaluation | Viral Diseases | Biology Document Number: 313953 |
| 26. Title: Does hormonal contraception modify the risk of STI acquisition? Author: World Health Organization [WHO]. Department of Reproductive Health and Research Source: Geneva, Switzerland, WHO, Department of Reproductive Health and Research, 2007. [2] p. (Provider Brief) Abstract: There are many factors that increase the chance of developing an STI. The most common ones are: having multiple sexual partners, having sexual intercourse with partners who have more than one sexual partner, not using condoms during intercourse, the presence of genital ulcer disease, young age, and previously having had an STI. What is not established is whether a woman's use of hormonal contraceptives may increase her risk of developing an STI. Hormonal methods include combined pills, combined injections, progestin-only injections such as DMPA (depot medroxyprogesterone acetate), progestin-only pills, the patch, the vaginal ring and implants. Numerous studies have investigated this subject, however the answers are not clear. What is clear is that none of these methods protects a woman from acquiring an STI; therefore, providers should counsel women at risk of infection to use condoms during each act of intercourse, even if they are already using another contraceptive method. (excerpt) Language: English Keywords: RESEARCH PROPOSAL | EVALUATION | WOMEN | DUAL PROTECTION | SEXUALLY TRANSMITTED DISEASES | INFECTION TRANSMISSION | CONTRACEPTIVE AGENTS, FEMALE | RISK ASSESSMENT | RISK BEHAVIOR | SEX BEHAVIOR | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Reproductive Tract Infections | Infections | Diseases | Contraceptive Agents | Behavior Document Number: 318980 |
| 27. Peer Reviewed Title: A study of the capability of manufacturers of generic hormonal contraceptives in lower- and middle-income countries. Author: Hall PE; Oehler J; Woo P; Zardo H; Chinery L; Singh JS; Jooseery SH; Essah NM Source: Contraception. 2007 Apr;75(4):311-317. Abstract: Studies were undertaken to assess the capability, competence and capacity of manufacturers of oral and injectable hormonal contraceptives in lower- and middle-income countries. A qualitative study on 41 companies, which comprised in-depth interviews and facility observations, was undertaken. Also an in-depth quantitative study of 14 companies was undertaken, of which 3 have not been included in the first study. Following review of a questionnaire and other documentation, a visit was undertaken to each factory to assess staff competence, manufacturing facilities, manufacturing processes, quality management, worker safety and environmental protection. Of the 44 companies from 15 countries, less than 30% would meet the current Good Manufacturing Practice requirements of the World Health Organization (WHO), the Pharmaceutical Inspection Cooperation Scheme or any stringent regulatory authority; a further 20% could comply with investment and improvements in quality management. Few companies are able to develop adequate registration dossiers. There is a limited number of companies that are capable of manufacturing high-quality generic products and which can provide a complete registration dossier for use outside their home markets. It is essential that, in the future, procurement agencies only use suppliers that are prequalified by WHO for the procurement of hormonal contraceptives. (author's) Language: English Keywords: DEVELOPING COUNTRIES | RESEARCH REPORT | QUALITATIVE RESEARCH | KAP SURVEYS | WORKERS | ADMINISTRATIVE PERSONNEL | CONTRACEPTIVE AGENTS, FEMALE | PRIVATE SECTOR | PRODUCTION | QUALITY CONTROL | WORKPLACE | OCCUPATIONAL HEALTH | MANAGEMENT | ENVIRONMENTAL PROTECTION | Research Methodology | Surveys | Sampling Studies | Studies | Labor Force | Human Resources | Economic Factors | Organization and Administration | Contraceptive Agents | Contraception | Family Planning | Macroeconomic Factors | Employment | Health | Natural Resources | Environment Document Number: 308440 |
| 28. Peer Reviewed Title: Optical imaging and analysis of human vaginal coating by drug delivery gels. Author: Henderson MH; Couchman GM; Walmer DK; Peters JJ; Owen DH Source: Contraception. 2007 Feb;75(2):142-151. Abstract: We used a new optical imaging technique to compare human intravaginal coating distributions of Conceptrol (Advanced Care Products, Brunswick, NJ) and Advantage (Columbia Laboratories, Aventuna, FL). These gels are surrogates for future microbicidal gels, differing in molecular structures and biophysical properties. For each protocol, a 3-mL gel bolus was inserted to the posterior fornix while the woman was in the supine position. She then either (1) remained supine (10 min); or (2) sat up (1 min), stood up (1 min), sat down (1 min) and returned to supine for a net elapsed time of 10 min. The imaging device is sized/shaped like a phallus, and measurements while the device was inserted provide data that simulate peri-intromission coating. Coating by Advantage was more extensive and uniform than coating by Conceptrol, with smaller bare spots of uncoated epithelium. Change in posture tended to increase extent and uniformity of coating, details differing between gels. Results are consistent with predictions of mechanistic coating theory, using gel rheological data as inputs. (author's) Language: English Keywords: UNITED STATES OF AMERICA | NORTH CAROLINA | RESEARCH REPORT | VAGINAL GEL | MICROBICIDES | CONTRACEPTIVE AGENTS, FEMALE | CONTRACEPTION RESEARCH | North America | Americas | Developed Countries | Vaginal Spermicides | Contraceptive Methods | Contraception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents Document Number: 311553 |
| 29. Peer Reviewed Title: Study design to evaluate the safety and effectiveness of hormonal contraception for women. Author: Kapp N; Curtis KM; Borgatta L Source: Clinical Obstetrics and Gynecology. 2007 Dec;50(4):850-867. Abstract: A discussion of the issues that affect the study design of hormonal contraception is presented, including ethical issues, measurement of contraceptive efficacy. Observational studies, experimental studies, and meta-analysis in hormonal contraception are also reviewed. (author's) Language: English Keywords: GLOBAL | CRITIQUE | STUDY DESIGN | DATA ANALYSIS | CONTRACEPTIVE AGENTS, FEMALE | CONTRACEPTIVE SAFETY | CONTRACEPTIVE EFFECTIVENESS | USER COMPLIANCE | BIAS | CONTRACEPTION CONTINUATION | Research Methodology | Contraceptive Agents | Contraception | Family Planning | Safety | Public Health | Health | Behavior | Error Sources | Measurement | Contraceptive Usage Document Number: 322244 |
| 30. Title: Contraception and lactation. Author: King J Source: Journal of Midwifery and Women's Health. 2007 Nov-Dec;52(6):614-620. Abstract: The benefits of breastfeeding for both the infant and the mother are undisputed. Longer intervals between births decrease fetal/infant and maternal complications. Lactation is an effective contraceptive for the first 6 months postpartum only if women breastfeed exclusively and at regular intervals, including nighttime. Because a high percentage of women in the United States supplement breastfeeding, it is important for these women to choose a method of contraception to prevent unintended pregnancies. Both the method of contraception and the timing of the initiation of contraceptives are important decisions that a clinician must help the breastfeeding woman make. Ideally, the chosen method of contraception should not interfere with lactation. This article reviews the research on the effect of contraceptives, including hormonal contraceptives, on lactation. (author's) Language: English Keywords: UNITED STATES OF AMERICA | LITERATURE REVIEW | CLINICAL RESEARCH | WOMEN | LACTATIONAL AMENORRHEA METHOD | TIME FACTORS | BREASTFEEDING, EXCLUSIVE | CONTRACEPTIVE USAGE | LACTATION | CONTRACEPTIVE METHODS | IUD | TUBAL LIGATION | NATURAL FAMILY PLANNING | CONTRACEPTIVE AGENTS, FEMALE | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Family Planning, Behavioral Methods | Family Planning | Population Dynamics | Breastfeeding | Infant Nutrition | Nutrition | Health | Contraception | Maternal Physiology | Physiology | Biology | Female Sterilization | Sterilization, Sexual | Contraceptive Agents Document Number: 323918 |
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