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From Research to Policy: the WHO with developing guidelines on the potential risk of HIV acquisition and progestogen-only contraception use.
Global Health: Science and Practice. 2017 Dec; 5(4):540-546.Add to my documents.
[Washington, D.C.], United States Agency for International Development [USAID], 2017 Jul. 3 p.The purpose of this technical update is to summarize current evidence and the World Health Organization (WHO) revised guidance regarding use of hormonal contraception (HC) by women at high risk of acquiring HIV. On March 2, 2017, WHO issued revised guidance on the use of progestogen-only injectables (norethisterone enanthate [NET-EN] and depot medroxyprogesterone acetate [DMPA], in both intramuscular [IM] and subcutaneous [SC] forms) by women at high risk of HIV acquisition. The recommendation was previously a Category 1 with a clarification, meaning there was no restriction on the use of the progestogen-only injectables, but women at high risk of HIV should be informed that use of those contraceptive methods may or may not increase risk of HIV acquisition. With the revised guidance, progestogen-only injectables are now classified as Category 2 for women at high risk of HIV acquisition. (excerpt)
[London, United Kingdom, IPPF], 2017 Jun. 3 p.The World Health Organization (WHO) issued revised guidance on the eligibility criteria for hormonal contraceptive use among women at high risk of acquiring HIV in March 2017. This update is critically important for women’s health, particularly in sub-Saharan Africa where HIV prevalence is high and injectable contraception is widely used.
Swiss Medical Weekly. 2017 Jun 21; 147:w14432.PURPOSE: Sayana(R) was introduced as the first depot medroxyprogesterone acetate-containing contraceptive that is administered via subcutaneous injection. Within 10 months, the Regional Pharmacovigilance Centre (RPVC) Zurich received several anonymous reports of serious local reactions after Sayana(R) administration. In this retrospective study, individual case safety reports (ICSRs) on local adverse drug reactions (ADRs) related to Sayana(R) were analysed from the WHO pharmacovigilance database. METHODS: International, national and regional ICSRs during Sayana(R) administration up to 1 January 2016 were examined. Data on ADRs were retrieved from the WHO Global Database VigiBase. Demographic data, drug administration information, duration of Sayana(R) treatment, latency time of the ADR, and its course, severity and outcomes were analysed. RESULTS: Worldwide, 398 ICSRs after Sayana(R) use were registered in the database. We identified 20 reported terms that were potentially used to describe a persistent lipodystrophy. When only cases containing one or more of these 20 reported terms were selected, 323 (81.2%) international ICSRs remained for analysis. Of those, 91.6% (n = 296) were categorised as serious. The majority of the reactions (n = 193, 54.4%) did not recover. In the 67 Swiss ICSRs, 77 ADRs were reported using 10 different terms including severe or persistent local reactions like lipodystrophy, atrophy or fat necrosis. Thirty-two patients (47.7%) did not recover. All 11 regional cases reported to the RPVC Zurich were categorised as serious ADRs. For the majority of the patients (n = 7, 63.6%) the interval between the application of Sayana(R) and development of the lipodystrophy was between 2 and 4 months. Most of the reactions were irreversible (n = 9, 81.8%). One patient underwent plastic surgery for artificial infill of the dent. CONCLUSIONS: Persistent local injection site reactions such as lipodystrophy, fat tissue necrosis or atrophy occur frequently after subcutaneous Sayana(R) use. These adverse drug reactions were recently integrated in the Swiss product information. Physicians and patients should be informed and advised about these potentially irreversible effects.
Hormonal contraceptive eligibility for women at high risk of HIV. Guidance statement. Recommendations concerning the use of hormonal contraceptive methods by women at high risk of HIV.
Geneva, Switzerland, WHO, 2017. 20 p. (WHO/RHR/17.04)The World Health Organization (WHO) convened a technical consultation during 1-2 December 2016 to review new evidence on the risk of HIV acquisition with the use of hormonal contraception. The issue was recognized as a critical one, particularly for sub-Saharan Africa, where women have a high lifetime risk of acquiring HIV, hormonal contraceptives constitute a significant component of the contraceptive method mix and unintended pregnancy is a common threat to the well-being and lives of women and girls. A wide range of stakeholders were present at this meeting, and serving on the Guideline Development Group (GDG) was global representation from experts in family planning and HIV, representatives from affected populations, clinicians, epidemiologists, researchers, programme managers, policy-makers and guideline methodologists. The GDG considered the following factors in making their determination for each contraceptive method: quality of the evidence (GRADE profile); values and preferences of contraceptive users and health care providers; balance of benefits and harms; priority of the problem; equity and human rights; acceptability; and feasibility. Through consensus, the GDG arrived at new recommendations for progestogen-only injectables. The recommendations for use of progestogen-only injectables among women at high risk of HIV changed from category 1 to category 2, with an accompanying clarification, in the Medical eligibility criteria for contraceptive use (MEC). Recommendations for all other methods of hormonal contraception remained unchanged. (Excerpts)
Training and reference guide for a screening checklist to initiate use of DMPA (or NET-EN). Second edition.
Research Triangle Park, North Carolina, Family Health International [FHI], 2009. 79 p. (USAID Cooperative Agreement No. GPO-A-00-05-00022-00)This training and reference guide was developed for family planning service providers interested in using the Checklist for Screening Clients Who Want to Initiate DMPA (or NET-EN), commonly referred to as the "DMPA Checklist". Designed to serve as both a training and reference tool, the guide is composed of two parts: a training module and a collection of essential, up-to-date reference materials. The guide is part of a series to train on other checklists. The DMPA Checklist was developed to assist service providers in screening clients who have already been counseled about contraceptive options and who have made an informed decision to use either of two popular injectable contraceptive methods: depot-medroxyprogesterone acetate (DMPA) or norethisterone enantate (NET-EN). This simple job aid is based on the technical guidance provided by the World Health Organization (WHO) in its Medical Eligibility Criteria for Contraceptive Use (2004, updated 2008). The checklist supports the application of these guidelines -- known as the WHO MEC -- into service delivery practice. (Excerpts)
WHO / USAID / FHI Technical Consultation: Expanding Access to Injectable Contraception, 15-17 June 2009, Room M405, WHO, Geneva.
[Unpublished] 2009. 5 p.The agenda for the consultation is presented. The objectives of the consultation were: To review systematically the evidence and programmatic experience on interventions designed to expand access to / provision of contraceptive injectables, focusing on non clinic-based services and programs; To reach conclusions on issues: (a) for which evidence is consistent and strong; (b) for which evidence is mixed; and (c) for which evidence is marginal or entirely lacking and, thus requires additional research; To document discussions and conclusions of the Consultation, including policy and program implications, and to disseminate these widely.
[Washington, D.C.], USAID, .  p.A technical consultation, co-sponsored by the World Health Organization (WHO), USAID, and Family Health International (FHI), was held June 15-17, 2009, at the WHO in Geneva to review the evidence and programmatic experience for community-based provision of injectable contraceptives. Thirty technical and program experts from countries and organizations reviewed the scientific evidence and experiences from programs that provided injectable contraceptives through community-based health workers (CHWs). This evidence and programmatic experience came from Africa, Asia, and Latin America and focused on depotmedroxyprogesterone acetate (DMPA). The evidence consistently showed that given appropriate training, CHWs can screen clients effectively, provide DMPA injections safely, and counsel on side effects appropriately, demonstrating competence equivalent to higher level facility-based providers of DMPA. Continuation of use of DMPA by clients of CHWs was as long as those of clients receiving injections at clinics. In addition, the vast majority of clients expressed satisfaction with CHW provision of DMPA. The Consultation concluded that sufficient evidence existed for national policies to support the introduction, continuation, and scale-up of community-based provision of progestin-only injectable contraceptives, especially DMPA. Provision of DMPA by CHWs will expand choice for underserved populations and contribute to reducing the unmet need for family planning. Operational guidelines for family planning should therefore reflect that appropriately trained CHWs can safely initiate use of DMPA and provide reinjection. (Excerpt)
A review of the evidence developed for a technical consultation on expanding access to injectable contraception.
[Research Triangle Park, North Carolina], Family Health International [FHI], 2009 Jun. 48 p.The document was prepared to facilitate deliberations for the Technical Consultation on Expanding Access to Injectable Contraceptives sponsored by the World Health Organization, the United States Agency for International Development, and Family Health International, scheduled to be held from 15-17 June 2009 in Geneva, Switzerland. This document summarizes the results of a literature review conducted to identify research evidence and program experience relevant to the objectives of the Technical Consultation: To review systematically the evidence and programmatic experience on interventions designed to expand access to / provision of contraceptive injectables, focusing on non clinic-based services and programs; To reach conclusions on issues: (a) for which evidence is consistent and strong; (b) for which evidence is mixed; and (c) for which evidence is marginal or entirely lacking and, thus requires additional research; To document discussions and conclusions of the Consultation, including policy and program implications, and to disseminate these widely. Use of community-based injectable services was significant in all studies reviewed. This evidence suggests that community-based delivery of injectable services by CHW is acceptable in a wide variety of settings. (Excerpts)
Community-based health workers can safely and effectively administer injectable contraceptives: Conclusions from a technical consultation.
Research Triangle Park, North Carolina, FHI, 2009. 4 p.In June 2009, a technical consultation held at the World Health Organization (WHO) in Geneva concluded that evidence supports the introduction, continuation, and scale-up of community-based provision of progestin-only injectable contraceptives. The group of 30 technical and programme experts reviewed scientific and programmatic experience, which largely focused on the progestin-only injectable, depot-medroxyprogesterone acetate (DMPA). The experts found that community-based provision of progestin-only injectable contraceptives by appropriately trained community health workers (CHWs) is safe, effective, and acceptable. Such services should be part of a family planning programme offering a range of contraceptive methods. (Excerpt)
Research Triangle Park, North Carolina, FHI, 2002.  p. (FHI Research Brief No. 6; RB-02-06E)Community-based workers worldwide use checklists to determine whether women are medically eligible to use combined oral contraceptives (COCs) or depot-medroxyprogesterone acetate (DMPA). However, problems may arise when outdated and inaccurate checklists are used. With input from dozens of experts, Family Health International developed new checklists that are easily understandable and consistent with the World Health Organization's (WHO) medical eligibility requirements. (author's)
Geneva, Switzerland, WHO, Department of Reproductive Health and Research, . 3 p.The development of new and improved methods of contraception for both women and men is a key component of the strategy to improve the quality of family planning programmes. Family planning clients are often restricted by the choice of methods offered to them, or are deterred from using contraception due to the side effects related to use of available methods. (excerpt)
Geneva, Switzerland, WHO, 1981. 76 p. (WHO Technical Report Series No. 657)This report on the effect of female sex hormones on fetal health and development aimed to evaluate research on the specific types of sex hormones and their uses, to determine their safety with respect to fetal development and infant health, and to recommend further research in these areas. Theoretically, sex hormones can affect any stage of fetal development. Sex hormones appear to act by promoting synthesis of messenger ribonucleic acid (mRNA) in target tissues, so that research should focus on the specific proteins formed under the direction of newly synthesized mRNA to elucidate potential morphological and physiological effects of exogenous hormones. Following are some research avenues: cytogenetic research, microscopic and macroscopic examination, observations on births and later life, animal teratology, and epidemiological studies. Epidemiological studies not only help elucidate causal associations but also provide public health data. Studies of sex hormones and fetal development and infant health must be free of bias and often suffer from problems of defining pregnancy outcome. Also sex steroids are frequently administered at the same time as other drugs, leading to confounding effects of drug interactions. In order to assess existing data, it is necessary to disaggregate the data from different reports and then to regroup them according to the indications for use, i.e., infertility, contraception, pregnancy testing, supportive therapy during pregnancy, contraception during pregnancy, contraception during breast feeding. Likewise data must be disaggregated according to different types of exposure, i.e., preconception or postconception. The bulk of this monograph is spent disaggregating study data based on the above-stated rationales. The following recommendations are made for indications for use of sex hormones: 1) they should not be used as pregnancy tests; 2) diethylstilbestrol should not be prescribed to a suspected pregnant woman; 3) benefits of progestin therapies must first be proven before they can be recommended for use in supporting pregnancy; 4) oral contraceptives given before pregnancy seem to have no effect on subsequent pregnancy; and during lactation combined therapy should not be given.
Geneva, Switzerland, WHO, 1978. (World Health Organization Technical Report Series No. 619) 54 pStudies on steroid contraception (SC) and risk of neoplasia are reviewed. Methodological issues in neoplasia etiology studies include: 1) possibility of a latent period between exposure to cause and disease development; 2) cumulative effects of prolonged or repeated SC exposure; 3) discontinued drugs or dosage schedules; 4) time of exposure (adolescence or prenatal, e.g.); 5) isolation of specific causes among multiple risks; and 6) variations in neoplasma diagnoses. The 4 epidemiological approaches to SC-associated neoplasia studies have inherent shortcomings, but cohorts yield significant associations. Relative risk (ratio of disease incidence among exposed vs. nonexposed persons) is an index of association only, not evidence of cause and effect. Benign breast neoplasia risk was reduced by current SC use of >2 years, and weak evidence points to a residual protective effect, apparently associated with progestogen dose. Aggregated breast cancer data show no clear adverse or beneficial effect of SC use; however, evidence suggests SCs may increase breast cancer risk in population subgroups (e.g., young women). Only short-term evidence is available; hence, no inference of long-term SC breast cancer effects is possible. No beneficial effect of SCs on uterine fibroids is evident, but sequential SCs, no longer marketed, may have increased risk to endometrial carcinoma. Inconclusive data suggest SCs may decrease ovarian cancer risk. Increased risk of cervical dysplasia and carcinoma in situ is associated with SC use, especially long-term use by women with predisposing factors. Risk of hepatocellular adenoma of the liver increases with prolonged SC exposure, especially high dose. Relevance of existing data from more developed countries to disease risk in less developed ones is discussed, and recommendations made.
Reproductive Health Matters. 2000 Nov; 8(16):188.Community-based programs use checklists to determine eligibility for use of combined oral contraceptives and the injectable Depo Provera, but these checklists can quickly become outdated as information about safety changes. In 1996 WHO updated the existing checklists, which are based on eligibility criteria. This article describes the participatory, consensus-building process that was used in modifying the checklists. Field testing highlighted the importance of being careful when translating guidelines into other languages. It was also found that there was a need for training in the use of the new checklists that focused on how they differ from the previous ones. The importance of providing a checklist guide to further clarify any issues was also stressed. (full text)
[Contraceptive fact sheets. A tool for advisors in logistics] Fiches factuelles sur les contraceptifs. Un outil pour les conseillers en logistique.
Arlington, Virginia, JSI, Family Planning Logistics Management Project, 1998.  p. (USAID Contract No. CCP-C-00-95-00028-04)This guide lists the visual indicators of eventual quality problems, special considerations, donors, manufacturers, brands, shelf life, primary and secondary conditioning, units per shipping crate, and the dimensions and weights of boxes of the following contraceptive methods: condoms, oral contraceptive pills, IUDs, injectables, contraceptive implants, spermicides, and other vaginal barrier methods. These methods are presented in different categories according to donor: USAID, IPPF, or FNUAP. These data are provided as a tool to consultants in logistics. References are given for additional information on each method discussed.
Directory of hormonal contraceptives 1996. 3rd ed. Repertoire des contraceptifs hormonaux 1996. 3e edition. Guia de anticonceptivos hormonales 1996. 3a edicion.
London, England, International Planned Parenthood Federation [IPPF], 1996. 102 p. (IPPF Medical Publications)The "Directory of Hormonal Contraceptives" lists the composition and manufacturer of all such methods available in the major world countries. By coding all products with the same composition or formula, despite different brand names, the directory enables family planning providers to advise clients as to whether an identical formulation is available in other countries to which they might be relocating. The first and second editions of this directory were very useful to family planning associations, individual physicians, and international organizations. Since publication of the second edition in 1992, many new hormonal products have become available and others have been discontinued. This third edition expands the categories of hormonal contraceptives from the original five to eight: combined pills, phasic pills, progestogen-only pills, progestogen injectables, combined injectables, implants, hormonal IUDs, and emergency contraception. A further change is inclusion of some countries with populations under 100,000 that are members or associate members of IPPF. Finally, products containing more than 50 mcg of estrogen are no longer included since this dose is seldom used.
Cardiovascular disease and use of oral and injectable progestogen-only contraceptives and combined injectable contraceptives. Results of an international, multicenter, case-control study. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception.
CONTRACEPTION. 1998 May; 57(5):315-24.As part of a World Health Organization Collaborative Study conducted at 21 centers in Africa, Asia, Europe, and Latin America in 1989-93, the risks of cardiovascular disease associated with use of oral and injectable progestogen-only and combined injectable contraceptives were investigated. 3697 cases of cardiovascular disease (59% stroke, 31% venous thromboembolism, and 10% acute myocardial infarction) were available for analysis and age-matched with up to three controls. 53 cases were current users of oral progestogen-only contraception, 37 were using an injectable progestogen-only method, and 13 were using combined injectable contraception. The adjusted odds ratios for all cardiovascular diseases compared with nonusers of any type of steroid hormone contraceptive were 1.4 (95% confidence interval (CI), 0.79-1.63) for current users of oral progestogen-only methods, 1.02 (95% CI, 0.68-1.54) for users of injectable progestogen-only contraceptives, and 0.95 (95% CI, 0.49-1.86) for use of combined injectable contraceptives. No significant changes in risk for stroke, venous thromboembolism, or acute myocardial infarction or these three conditions combined was apparent in association with any of the contraceptive methods. However, a nonsignificant increase in risk of venous thromboembolism was apparent for both types of progestogen-only contraceptives. Among women with a history of hypertension, the odds ratio for stroke rose from 7.2 (95% CI, 6.1-8.5) among nonusers of any type of steroid hormonal contraceptive method to 12.4 (95% CI, 4.1-37.6) among current users of all oral progestogens.
In: Female contraception: update and trends, edited by B. Runnebaum, T. Rabe, L. Kiesel. Berlin, Germany, Federal Republic of, Springer-Verlag, 1988. 385-92.From the mid-1970s the pharmaceutical industry has played a reduced role in contraceptive development because time-consuming preclinical requirements and opposition of some methods by consumer advocates have made development much more expensive. In the future contraceptive needs could be satisfied by relatively inexpensive, easy-to-use methods that could be made widely available in developing countries and even manufactured in these countries. These include once-a-month injectables, new spermicides, and subdermal, long-acting steroid pellets. The process of research and development encompasses the distinct stages of feasibility assessment, product definition, product testing, and market testing. Public sector agencies must contract with academic or commercial institutions when developing new methods. The World Health Organization (WHO) Special Program of Research in Human Reproduction is an example of such collaboration. A new attitude is also required in order to avoid duplication as exemplified by the collaboration between the Population Council, Family Health International, and the Program for the Introduction and Adaptation of Contraceptive Technology. Some of the most promising new methods include Norplant, which will likely be granted FDA approval; the 90-day PolyNET intramuscular injectable also slated for FDA approval; and monthly injectables including two-monthly progestogen-estrogen formulations projected to undergo phase III clinical trials involving 200 women during 1987. Among spermicides the most intriguing is Propranolol, the beta blocker used for hypertension. Its toxicology and teratology are well understood. Making new methods available in developing countries requires the participation of international donor agencies, such as the US Agency for International Development, which spent $30.4 million on contraceptive commodities. Similarly, the role of the FDA, the Swedish and Japanese development agencies as well as that of UNFPA and IPPF are crucial in this endeavor.
JOURNAL OF REPRODUCTIVE MEDICINE. 1996 May; 41(5 Suppl):419-25.This article reviews recent epidemiological data assessing the risk of breast, endometrial, ovarian, and cervical cancer in women using the injectable contraceptive depot medroxyprogesterone acetate (DMPA). A review is also provided of epidemiological and biostatistical concepts which relate to the literature on the relationship between the use of hormonal contraception and cancer. Breast cancer is a common and lethal disease in the US, and evidence suggests that gonadal steroids play a role in the development of breast cancer. Two major case control studies (one in New Zealand and the other under the auspices of the World Health Organization [WHO]) as well as a pooled analysis of these studies found no increased overall breast cancer risk in DMPA users. A currently unexplained pattern of increased risk in recent users mimics that seen with oral contraceptive (OC) use and term pregnancy. A WHO hospital-based study of the relationship between endometrial cancer and DMPA use found a protective effect of DMPA which appeared to be longterm and as great as that associated with OCs. Whereas it is plausible that DMPA, which suppresses ovulation, would lower the risk of ovarian cancer in users, a WHO case-control and hospital-based study failed to uncover such a protective effect. Studies of the routine use of DMPA in nulliparous women (who have higher risk of ovarian cancer) will shed more light on any effect DMPA may have on ovarian cancer. The unique epidemiology of cervical cancer (including number of sexual partners, use of barrier contraception, and frequent screening) makes it difficult to assess any association with contraceptive use. However, a large population-based, case-control study in Costa Rica; a WHO hospital-based, case-control study in Thailand, Mexico, and Kenya; and a study in New Zealand indicate that the risk of cervical neoplasia does not appear to be affected by DMPA use. While some issues regarding DMPA and the risk of reproductive tract carcinoma remain to be resolved, clinicians can be reassured that, for appropriately selected clients, the substantial benefits of DMPA outweigh any risks.
IPPF MEDICAL BULLETIN. 1992 Apr; 26(2):4.At a meeting in November 1991, the International Medical Advisory Panel (IMAP) of the International Planned Parenthood Federation (IPPF) was asked by the South Asia Region of IPPF to consider a report by the Bangladesh Family Planning Program concerning the operational implications of using more than one formulation of injectable contraceptive in a geographic area. The report states that depot medroxyprogesterone acetate (DMPA) and norethisterone enanthate (NET-EN) are very similar in terms of continuation rates, use-effectiveness levels, and reported side effects. However, they differ in administration schedule (DMPA is given at three month intervals; the other is given at two) and viscosity (NET-EN is more viscous and requires a larger bore needle than the other), which can lead to delivery problems for outreach programs. 50% of the contraceptive methods offered and used in these programs are injectables. Maintaining both types of injectables can lead to fieldworker confusion and error, disruption of fieldworker work routines, managerial burden, and supply shortages. IMAP recommends that family planning program managers select one progestogen-only injectable formulation and keep to it, to ensure that only one formulation is used in a particular geographic area. DMPA and NET-EN should not be considered medically interchangeable. They have different formulations and different periods of effectiveness. There is no data on the medical consequences of women receiving the two interchangeably because of program problems or errors.
In: Annual technical report, 1992, [of the] World Health Organization [WHO]. Special Programme of Research, Development and Research Training in Human Reproduction. Geneva, Switzerland, WHO, 1993. 145-60. (WHO/HRP/ATR/92/93)In 1991, the World Health Organization's Special Programme of Research, Development, and Research Training in Human Reproduction established a Task Force on Research on the Introduction and Transfer of Technologies for Fertility Regulation. The goal of the Task Force is to help agencies optimize the use of fertility regulation technologies and to broaden contraception options for informed users. Thus, the Task Force objectives include generating and distributing information, determining service delivery and user needs, and facilitating the transfer of contraceptive technologies. This 1992 annual report of the Task Force describes its new operational strategy as moving through three stages during the introductory process: a preliminary assessment, an introductory trial, and evaluation of research surrounding the trial and expansion of introduction. Specific planned, ongoing, and completed projects are described for each stage. Ongoing and planned projects to develop IEC (information, education, and communication) materials are also discussed. The Task Force also addresses product management issues which insure a sustainable supply of products (including the establishment of new and the monitoring of existing hormonal contraception production facilities). The report ends by describing ways in which the Task Force collaborates with other agencies as well as its efforts to disseminate information through women's health advocacy groups and a symposium. The work of the Task Force has been largely dominated by efforts to introduce the monthly injectable, Cyclofem, in developing countries.
In: Annual technical report, 1992, [of the] World Health Organization [WHO]. Special Programme of Research, Development and Research Training in Human Reproduction. Geneva, Switzerland, WHO, 1993. 23-36. (WHO/HRP/ATR/92/93)This 1992 annual report of the Task Force on Long-acting Systemic Agents for Fertility Regulation of the World Health Organization's Special Programme of Research, Development, and Research Training in Human Reproduction states that the main objectives of the Task Force are the development of new compounds and/or delivery systems which are superior to existing methods and which are easily delivered by family planning programs. Projects completed in 1992 include a major Phase III clinical trial comparing the once-a-month injectables (which induce regular monthly estrogen-withdrawal bleeding) Mesigyna and Cyclofem in 12 centers in Egypt, a Phase III clinical trial comparing these agents with the Chinese Injectable No. 1 in China, a multicenter study of the effects of Mesigyna and Cyclofem on lipid metabolism and on coagulation and fibrinolysis, and a study in Mexico of the return of fertility after discontinuation of the injectables. Also completed in 1992 were two studies on the pharmacokinetics of the injectables depot medroxyprogesterone acetate and norethisterone enanthate (NET) and a multicenter Phase II study comparing levonorgestrel butanoate (HRP002) to NET. Because of the favorable results of this last study, pharmacokinetic studies of an improved formulation of HRP002 are ongoing. A Phase III clinical trial of the vaginal rings in the UK revealed that a number of users developed vaginal lesions. This development will be given priority in further tests. Other ongoing and planned activities of the Task Force revolve around attempts to develop hormonal postpartum contraception which prevents exposure of breast-fed infants to synthetic steroids and attempts to deal with the problem of unpredictable endometrial bleeding associated with progestogen-only methods.
PROGRESS IN HUMAN REPRODUCTION RESEARCH. 1995; (33):2.Research results by the UNDP/UNFPA/WHO/World Bank Special Program in Human Reproduction published in 1990 showed that hormones can be used to reduce men's sperm levels to virtual infertility. Weekly injections of testosterone enanthate (TE) produced azoospermia in most men. A multicenter study was also completed in 1994 involving a total 399 men in nine countries who were given regular injections of TE. High contraceptive effectiveness resulted among those men whose sperm concentrations were reduced to 3 million or less per ml (oligozoospermia). The failure rate was 1.4 pregnancies per 100 person-years, similar to that of oral contraceptives. It took an average of 68 days to reach oligozoospermic and 100 days to reach azoospermic sperm counts after the 1st injection. To return to normal levels after the last injection took 112 days and 203 days, respectively, in oligozoospermic and azoospermic men. Testing of testosterone buciclate (TB) was also carried out in Germany to assess the effect of longer-acting androgen esters suppressing gonadotrophin secretion. Azoospermia was achieved in some men by giving a single dose of 1200 mg of TB, but at half that dose oligozoospermia was not reached. Research is also continuing into the male contraceptive effect of progestogen-androgen combinations. Progestogen prevents the production of sperm at much lower doses than androgen. Androgen is given to replace testosterone that is inhibited as a result of the suppression of gonadotrophin, but it is needed less frequently. The combination seems to suppress sperm production more quickly than the androgen alone. In China, India, and Indonesia, plans are prepared for efficacy studies with such combinations. The drawback for large-scale use is that the components have to be injected at different intervals. This may be overcome by combining TB with a progestogen with the same duration of action and giving both at the same time.
FAMILY PLANNING WORLD. 1993 Jul-Aug; 3(4):7, 21.The discussion focused on the variations in purchasing agreements for the injectable Depo-Provera. Negotiations are in process between the manufacturer in the US (the UpJohn Company) and USAID regarding size of purchase, prices, and time schedules. A glitch is that the US production plant provides a two-year shelf life for the product, while the Belgian plants provide a three-year shelf life. The one year difference could be significant in the distribution to hard-to-reach places, but the balancing point is that USAIDs effort are a positive development for expanding distribution. The UN Population Fund (UNFPA) and the International Planner Parenthood Federation (IPPF) already distribute Depo-Provera and were charged 72 and 75 cents, respectively; UpJohn recently increased the prices to 80 and 85 cents. The UNFPA prices were slightly lower due to larger purchases, and both concerns will be awaiting the outcome of USAID's price negotiations. Other manufacturers are a company in Indonesia, which sells only within the country, and Organon in Holland, which produces the drug under the name Megstron. UpJohn has the major share of the market. The cost of supplying Depo-Provera also includes the purchase of needles and syringes. Other international agencies are not limited by anything other than finding the lowest cost. UNFPA buys its supplies in Belgium at low cost and its contraceptives in Holland. USAID, however, must purchase needles and syringes from American facilities. IPPF will be watching to assure international organizations that no duplication of effort will occur with the USAID distribution and expects the shelf life problem to be resolved. The issue may be cleared up when UpJohn has sufficient time to resubmit its application with enough research to support the 3-year shelf life; the FDA had rejected Depo-Provera repeatedly since 1961, and the approval was granted on a rushed application that only included some of the Belgian research and could empirically only support a 2-year shelf life.