Aiming for quality in Iran's national family planning program - two decades of sustained efforts.

The Iranian family planning program was relaunched in 1989 to improve maternal and child health. As coverage was extended throughout the country, it had the challenge to achieve harmonization and improve and maintain quality of care. Five strategies were put in place: (1) expand the method mix, (2) standardize provider training through the adoption of national norms and guidelines, (3) facilitate and harmonize service provision, (4) improve integration of family planning in family health services and (5) address myths and misconceptions surrounding contraception in the general population. This was supported by regular monitoring and evaluation. To date, this program is regarded as one of the most successful programs worldwide. While the direct impact of these quality improvements is difficult to evaluate, it is believed to have built the trust that family planning clients place in the program. Challenges remain, particularly facing a total fertility rate below replacement level nationally and providing quality services to an ever-growing peri-urban population.

Treatment of vaginal bleeding irregularities induced by progestin only contraceptives.

BACKGROUND: Despite their high effectiveness, progestin-only contraceptives are considered less than ideal by the many women who experience irregular vaginal bleeding when using them. Current treatments to control these bleeding problems are not sufficiently effective. OBJECTIVES: We evaluated preventive and therapeutic approaches to normalise bleeding irregularities associated with the use of progestin-only contraceptives. SEARCH METHODS: Literature was identified through database searches, reference lists, organisations and individuals, covering the period until May-June 2012. SELECTION CRITERIA: Trials with random or systematic allocation, testing interventions for the prevention or treatment of bleeding irregularities associated with the use of progestin-only contraceptives were eligible. DATA COLLECTION AND ANALYSIS: Results are expressed as relative risks (RR) with 95% confidence interval (CI) for categorical data and as weighted mean difference (WMD) with 95% CI for continuous data. When we encountered heterogeneity (visual or statistical) we used the random-effects model (quantitative) or did not produce a summary estimate (qualitative). MAIN RESULTS: Thirty-three randomised controlled trials enrolling 3677 participants were included. Two thirds of the trials were determined to reflect low to moderate risk of bias.Estrogen treatments reduced the number of days of an ongoing bleeding episode in DMPA and Norplant users. However, treatment frequently led to more discontinuation due to gastrointestinal upset.Combinations of oral ethinyl estradiol and levonorgestrel improved bleeding patterns in Norplant users, but method discontinuation rates were unchanged. One trial reported successful use of combined oral contraceptives in treating amenorrhea among DMPA users.Norplant users, but not Implanon users, administered the anti-progestin mifepristone reported fewer days of bleeding during treatment than those given placebo. Mifepristone used monthly by new Norplant acceptors reduced bleeding, when compared to placebo.A variety of NSAIDS have been evaluated for their ability to treat abnormal bleeding, with mixed results.Norplant users receiving SERM (tamoxifen) had less unacceptable bleeding after treatment and were more likely to continue using Norplant than those receiving placebo.Tranexamic acid, mifepristone combined with an estrogen and doxycycline were more effective than placebo in terminating an episode of bleeding in women using progestin-only contraceptives, according to three small studies. AUTHORS' CONCLUSIONS: Some women may benefit from the interventions described, particularly with cessation of current bleeding. Several regimens offer promise in regulating bleeding, but findings need to be reproduced in larger trials. The results of this review do not support routine clinical use of any of the regimens included in the trials, particularly for long-term effect.

Monitoring of ovarian activity by daily measurement of urinary excretion rates of oestrone glucuronide and pregnanediol glucuronide using the Ovarian Monitor, Part III: variability of normal menstrual cycle profiles.

STUDY QUESTION: What are the characteristics of, and how variable are, individual normal menstrual cycle profiles of excretion rates for the urinary metabolites oestrone glucuronide (E1G) and pregnanediol glucuronide (PdG)? SUMMARY ANSWER: There is a continuum of menstrual cycle profiles that differ from standard textbook profiles but which can be understood simply in terms of growth, atresia and ovulation of ovarian follicles. WHAT IS KNOWN ALREADY: Point-of-care assays with the Ovarian Monitor pre-coated assay tubes, using urine samples diluted to a constant volume per unit time, give laboratory accurate clinical data for individual menstrual cycles. Lay operators can perform the point-of-care assay system at home to achieve reliable and reproducible results, which can be used for natural family planning. STUDY DESIGN, SIZE, DURATION: This prospective study involved 62 women, with normal menstrual cycles, recruited from three centres: Palmerston North, New Zealand, Sydney, Australia and Santiago, Chile. The study lasted 3 years. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women collected daily urine samples and determined their E1G and PdG rates with a pre-coated enzyme assay system known as the Ovarian Monitor. For two cycles, the assays were repeated in a study centre and the results were averaged to give 113 individual menstrual cycles for analysis. The cycles were displayed individually in a proprietary database program. MAIN RESULTS AND THE ROLE OF CHANCE: The individual normal hormonal profiles were more complex than the classic composite curves for 40% of the cycles. Of 113 ostensibly normal cycles, only 91 were potentially fertile and 22 had some luteal phase defect. The oestrone glucuronide and PdG excretion rates were reliable and informative in the non-invasive elucidation of ovulation and ovarian function for both simple and complex profiles. Daily monitoring revealed the variability of normal menstrual cycle profiles. The LH peaks were variable and ambiguous markers for ovulation. LIMITATIONS, REASONS FOR CAUTION: The study consisted of cycles only from women with regular cycles of 20-40 days duration. All the women were intending to avoid a pregnancy during the study thus the limits of the fertile window were not tested. WIDER IMPLICATIONS OF THE FINDINGS: The principles established in this study should apply to cycles of any length. All peaks in oestrone glucuronide excretion should be tested by concurrent measurements of PdG, which gives a positive indication of the fate of the follicle it represents. The Ovarian Monitor provides a useful addition for practitioners of natural family planning. STUDY FUNDING/COMPETING INTEREST(S): Financial support for this study was obtained from the UNDP/UNFPA/World Bank/WHO Special Programme of Research, Development and Research Training in Human Reproduction (HRP). D.G.C. is currently employed by and holds stock in Manawatu Diagnostics Ltd, a company in the development phase of a potentially competing product. The remaining authors have nothing to declare.

Expanding contraceptive choice in the developing world: lessons from the Lao People's Democratic Republic and the Republic of Zambia.

BACKGROUND AND OBJECTIVES: Women need different forms of contraception over their lifetime. In the developed world, they have access to some 20 different methods. In developing countries, only a few options are available. This paper focuses on four under-used methods: intrauterine devices, implants, emergency contraception and female condoms. It examines reasons for their low uptake, strategies used for their adoption, and challenges in sustaining these efforts, in two countries: Laos and Zambia. METHODS: In-country documentation and reports from international partners were reviewed; questionnaires were sent and interviews carried out with ministry officials, senior providers, and local representatives of international organisations and international non-governmental organisations. RESULTS: In Laos, the family planning programme is relatively young; its challenges include ensuring the sustainability of services and supplies, improving the quality of IEC to dispel misconceptions surrounding contraception, and developing novel distribution systems to reach rural populations. Zambia has a much older programme, which lost ground in the face of competing health priorities. Its challenges include strengthening the supply chain management, coordinating the multiple groups of providers and ensuring the sustainability of services in rural areas. CONCLUSIONS: The contrast offered by Laos and Zambia illustrates the importance of regular evaluation to identify priority areas for improving contraceptive delivery.

Treatment of vaginal bleeding irregularities induced by progestin only contraceptives.

BACKGROUND: Despite their high effectiveness, progestin-only contraceptives are considered less than ideal by the many women who experience irregular vaginal bleeding when using them. Current treatments to control these bleeding problems are not sufficiently effective. OBJECTIVES: We evaluated preventive and therapeutic approaches to normalise bleeding irregularities associated with the use of progestin-only contraceptives. SEARCH METHODS: Literature was identified through database searches, reference lists, organisations and individuals, covering the period until May-June 2012. SELECTION CRITERIA: Trials with random or systematic allocation, testing interventions for the prevention or treatment of bleeding irregularities associated with the use of progestin-only contraceptives were eligible. DATA COLLECTION AND ANALYSIS: Results are expressed as relative risks (RR) with 95% confidence interval (CI) for categorical data and as weighted mean difference (WMD) with 95% CI for continuous data. When we encountered heterogeneity (visual or statistical) we used the random-effects model (quantitative) or did not produce a summary estimate (qualitative). MAIN RESULTS: Thirty-three randomised controlled trials enrolling 3677 participants were included. Two thirds of the trials were determined to reflect low to moderate risk of bias.Estrogen treatments reduced the number of days of an ongoing bleeding episode in DMPA and Norplant users. However, treatment frequently led to more discontinuation due to gastrointestinal upset.Combinations of oral ethinyl estradiol and levonorgestrel improved bleeding patterns in Norplant users, but method discontinuation rates were unchanged. One trial reported successful use of combined oral contraceptives in treating amenorrhea among DMPA users.Norplant users, but not Implanon users, administered the anti-progestin mifepristone reported fewer days of bleeding during treatment than those given placebo. Mifepristone used monthly by new Norplant acceptors reduced bleeding, when compared to placebo.A variety of NSAIDS have been evaluated for their ability to treat abnormal bleeding, with mixed results.Norplant users receiving SERM (tamoxifen) had less unacceptable bleeding after treatment and were more likely to continue using Norplant than those receiving placebo.Tranexamic acid, mifepristone combined with an estrogen and doxycycline were more effective than placebo in terminating an episode of bleeding in women using progestin-only contraceptives, according to three small studies. AUTHORS' CONCLUSIONS: Some women may benefit from the interventions described, particularly with cessation of current bleeding. Several regimens offer promise in regulating bleeding, but findings need to be reproduced in larger trials. The results of this review do not support routine clinical use of any of the regimens included in the trials, particularly for long-term effect.

Combination injectable contraceptives for contraception.

BACKGROUND: Combination injectable contraceptives (CICs) provide a highly effective, reversible method of preventing pregnancy, and they do not require daily administration or use at the time of coitus. Although they are used in many countries, their acceptability could be limited by method characteristics, such as the need to obtain a monthly injection or bleeding pattern changes. OBJECTIVES: To assess the contraceptive efficacy, bleeding patterns, discontinuation, user preferences, and side effects of CICs. SEARCH METHODS: In January and February 2013, we searched for randomized controlled trials (RCTs) of combination injectable contraceptives.Databases include MEDLINE, POPLINE, CENTRAL, EMBASE, and LILACS.We searched for current trials in ClinicalTrials.gov and ICTRP.Earlier searches also included AIM and IMEMR. For the initial review, we also assessed the references listed in review articles and in the eligible trial reports. SELECTION CRITERIA: RCTs were eligible if they compared a combination injectable contraceptive with any other contraceptive method (e.g., a second CIC,a progestin-only injectable contraceptive, another hormonal contraceptive or a barrier method) or a placebo. We limited the review to marketed CICs. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data on contraceptive efficacy, bleeding patterns, continuation, and side effects. We calculated the Peto odds ratio or mean difference with 95% confidence interval for dichotomous or continuous outcome, respectively. Survival analysis estimates for method discontinuation were presented where available. MAIN RESULTS: Twelve trials met the inclusion criteria. Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA)25 mg plus estradiol cypionate (E(2)C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E(2)V) 5mg. These contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems than progestin-only contraceptives. However, rates were higher for overall discontinuation and discontinuation due to other medical reasons.Acceptability results favored the CIC in one study and the progestin-only in another.Studies comparing two CICs found that NET-EN 50 mg plus E(2)V (5)mg resulted in less overall discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E(2)C 5 mg. However, these differences were not detected in all trials.The NET-EN plus E (2) V group also had more regular bleeding and fewer prolonged bleeding reference periods than the DMPA plus E(2)C group. The groups did not differ in their amenorrhea rates. AUTHORS' CONCLUSIONS: While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation depends on many factors. Future research should be directed toward improving the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinics, methods for women to administer their own injections, and counseling about possible bleeding pattern changes.

The special programme of research in human reproduction: forty years of activities to achieve reproductive health for all.

The Special Programme of Research in Human Reproduction (HRP), co-sponsored by the UNDP, UNFPA, WHO, and the World Bank, is celebrating 40 years of activities with an expansion of its mandate and new co-sponsors. When it began, in 1972, the main focus was on evaluating the acceptability, effectiveness, and safety of existing fertility-regulating methods, as well as developing new, improved modalities for family planning. In 1994, HRP not only made major contributions to the Plan of Action of the International Conference on Population and Development (ICPD); it also broadened its scope of work to include other aspects of health dealing with sexuality and reproduction, adding a specific perspective on gender issues and human rights. In 2002, HRP's mandate was once again broadened to include sexually transmitted infections and HIV/AIDS and in 2003 it was further expanded to research activities on preventing violence against women and its many dire health consequences. Today, the work of the Programme includes research on: the sexual and reproductive health of adolescents, women, and men; maternal and perinatal health; reproductive tract and sexually transmitted infections (including HIV/AIDS); family planning; infertility; unsafe abortion; sexual health; screening for cancer of the cervix in developing countries, and gender and reproductive rights. Additional activities by the Programme have included: fostering international cooperation in the field of human reproduction; the elaboration of WHO's first Global Reproductive Health Strategy; work leading to the inclusion of ICPD's goal 'reproductive health for all by 2015' into the Millennium Development Goal framework; the promotion of critical interagency statements on the public health, legal, and human rights implications of female genital mutilation and gender-biased sex selection. Finally, HRP has been involved in the creation of guidelines and tools, such as the 'Medical eligibility criteria for contraceptive use', the 'Global handbook for family planning providers', the 'Definition of core competencies in primary health care', and designing tools for operationalizing a human rights approach to sexual and reproductive health programmes.

Monitoring of ovarian activity by measurement of urinary excretion rates of estrone glucuronide and pregnanediol glucuronide using the Ovarian Monitor, Part II: reliability of home testing.

BACKGROUND: The UNDP/WHO/World Bank/Special Programme of Research, Development and Research Training in Human Reproduction (Geneva) set up a study to determine whether it is feasible for women to monitor their ovarian activity reliably by home testing. Daily self-monitoring of urinary hormone metabolites for menstrual cycle assessment was evaluated by comparison of results obtained with the Home Ovarian Monitor by untrained users both at home and in study centres. METHODS: Women collected daily data for urinary estrone glucuronide (E1G) and pregnanediol glucuronide (PdG) for two cycles, then the procedure was repeated in the women's local centre (in Chile, Australia or New Zealand) giving a total of 113 duplicate cycles. The tests were performed without the benefit of replicates or quality controls. The home and centre cycles were normalized and compared to identify assay errors, and the resulting home and centre menstrual cycle profiles were averaged. RESULTS: Reliable mean cycle profiles were obtained with the home and centre excretion rates agreeing to within 36 ± 21 nmol/24 h for E1G and 0.77 ± 0.28 µmol/24 h for baseline PdG values (1-5 µmol/24 h). The cycles had a mean length of 28.1 ± 3.1 days (n = 112; 5th and 95th percentiles: 24 and 35 days, respectively), a mean follicular phase of 14.8 ± 3.1 days (n = 107; 5th and 95th percentiles: 11 and 21 days) and a mean luteal phase length of 13.3 ± 1.5 days (n = 106; 5th and 95th percentiles: 11 and 17 days), calculated from the day of the LH peak. CONCLUSIONS: The study confirmed that the Ovarian Monitor pre-coated assay tubes worked well even in the hands of lay users, without standard curves, quality controls or replicates. Point-of-care monitoring to give reliable fertility data is feasible.

Accelerating science-driven solutions to challenges in global reproductive health: a new framework for moving forward.

Recommendations shaping policies, programs, and practices in global health should be based on the best available science, but how best to achieve this objective is less clear. We describe a new approach developed by the United Nations Development Programme/United Nations Population Fund/World Health Organization/World Bank Special Programme of Research, Development and Research Training in Human Reproduction within the World Health Organization Department of Reproductive Health and Research for addressing key challenges in global reproductive health. This approach leads to new recommendations for accelerating solutions to priority needs in the field and continued improvements in the science base-including the implementation science base-for meeting these needs. The key components of this new cycle for science-driven solutions include: 1) identifying priority needs of the field; 2) creating guidance that meets the needs of the field; 3) identifying research gaps and establishing and funding research priorities; 4) research synthesis and updating of the guidance in a timely fashion; and 5) supporting utilization in countries through systematic introduction of science-driven solutions. There is a synergistic effect when the contributions of the individual components of this cycle are linked. Strong institutional support is required for this collective effort, as is the creation of a team of researchers, practitioners, donors, and implementing agencies with shared responsibilities for its success. This new approach has already made important contributions toward addressing key challenges in family planning and maternal and perinatal health. We believe that it will help bridge the gap between knowledge and action for reproductive health and for global health more broadly.

Women's views and experiences of their vaginal bleeding patterns: an international perspective from Norplant users.

OBJECTIVES: Contraceptive-induced vaginal bleeding changes may be an undesired side effect, or a welcome opportunity to alter menstrual patterns. In Europe and the US, such changes are increasingly accepted; this study explores the perceptions of women around the globe. METHODS: Norplant users from five countries (Chile, China, the Dominican Republic, Indonesia and Tunisia; N = 486) were surveyed at entry into a contraceptive clinical trial regarding preferred frequency of menstruation, menses-associated symptoms, and activities during menses. RESULTS: Most women preferred once-monthly menstruation (81%); women in Chile, younger women, women neither married nor cohabitating, Christian women, and women experienced with hormonal contraception were more likely to accept alternative bleeding patterns. Women in Tunisia and Chile reported more symptoms associated with menses, while women in Beijing reported very few; decreased energy (32%), headaches (26%), abdominal pain (23%) and depression (22%) were most common. Avoidance of activities during menses such as physical work, sports, praying and entering religious sites, was closely tied to study centre. Across all sites, women (90%) avoided sexual intercourse during menses. CONCLUSIONS: Despite growing acceptance of altering bleeding patterns, women in this study preferred monthly vaginal bleeding. Understanding sociocultural contexts and individual preferences is important when addressing this issue with women from diverse backgrounds.

Defining research to improve health systems.

Robert Terry and colleagues present working definitions of operational research, implementation research, and health systems research within the context of research to strengthen health systems.

Combination injectable contraceptives for contraception.

BACKGROUND: Combination injectable contraceptives provide a highly effective, reversible method of preventing pregnancy, and they do not require daily administration or use at the time of coitus. Although they are used in many countries, their acceptability could be limited by method characteristics, such as the need to obtain a monthly injection or bleeding pattern changes. OBJECTIVES: To assess the contraceptive efficacy, bleeding patterns, discontinuation, user preferences, and side effects of combination injectable contraceptives. SEARCH STRATEGY: We searched computerized databases for randomized controlled trials of combination injectable contraceptives. SELECTION CRITERIA: Randomized controlled trials were eligible if they compared a combination injectable with any other contraceptive method (e.g., a second combination injectable contraceptive, progestin-only injectable contraceptive, other hormonal contraceptive or barrier method) or placebo. We limited the review to currently marketed combination injectable contraceptives. DATA COLLECTION AND ANALYSIS: One author evaluated all titles and abstracts from the literature searches to determine their eligibility. Two authors independently extracted data from the eligible trials. Data on contraceptive efficacy, bleeding patterns, continuation, and side effects were entered and analyzed with RevMan. MAIN RESULTS: Combination injectable contraceptives include depot medroxyprogesterone acetate (DMPA) 25 mg plus estradiol cypionate (E(2)C) 5 mg, as well as norethisterone enanthate (NET-EN) 50 mg plus estradiol valerate (E(2)V) 5 mg. These contraceptives resulted in lower rates of early study discontinuation due to amenorrhea or other bleeding problems than progestin-only contraceptives. However, rates were higher for overall discontinuation and discontinuation due to other medical reasons. Acceptability results favored the combination injectable in one study and the progestin-only in another.Studies comparing two combination injectable contraceptives found that NET-EN 50 mg plus E(2)V 5 mg resulted in less overall discontinuation and less discontinuation due to amenorrhea or prolonged bleeding than DMPA 25 mg plus E(2)C 5 mg. However, these differences were not detected in all trials. The NET-EN plus E(2)V group also had more regular bleeding and fewer prolonged bleeding reference periods than the DMPA plus E(2)C group. The groups did not differ in their amenorrhea rates. AUTHORS' CONCLUSIONS: While discontinuation rates can be viewed as a measure of method acceptability, the findings should be interpreted with caution since discontinuation depends on many factors. Future research should be directed toward interventions to improve the acceptability of combination injectable contraceptives, such as providing injections in settings more convenient than clinics, methods for women to administer their own injections, and counseling about possible bleeding pattern changes.

Copper-containing, framed intrauterine devices for contraception: a systematic review of randomized controlled trials.

BACKGROUND: Intrauterine devices (IUDs) are safe and effective methods of long-term reversible contraception. The design and copper content as well as placement of the copper on IUDs could affect their effectiveness and side effect profile. We compared different copper IUDs for their effectiveness and side effects. STUDY DESIGN: We searched multiple electronic databases with appropriate keywords and names of the IUDs known to be on the market. We searched the reference lists of papers identified and contacted authors when possible. There was no language restriction. Randomized controlled trials comparing different IUDs that reported on clinical outcomes were considered for inclusion. Two reviewers independently extracted data on outcomes and trial characteristics. We combined the trial results in meta-analyses and expressed results as rate difference (RD) using a fixed-effects model with 95% confidence interval (CI). In the presence of significant heterogeneity, a random-effects model was applied. RESULTS: We included 35 trials, resulting in 18 comparisons of 10 different IUDs in approximately 48,000 women. TCu380A was more effective in preventing pregnancy than MLCu375 (RD 1.70%, 95% CI 0.07-2.95% after 4 years of use). TCu380A was also more effective than MLCu250, TCu220 and TCu200. There tended to be fewer pregnancies with TCu380S compared to TCu380A after the first year of use, a difference which was statistically significant in the fourth year (RD -1.62%, 95% CI -3.00% to -0.24%). This occurred despite more expulsions with TCu380S (RD 3.50%, 95% CI 0.36-6.63% at 4 years). MLCu375 was no more effective than TCu220 at 1 year of use, or MLCu250 and NovaT up to 3 years. Compared to TCu380A or TCu380S, none of the IUDs showed any benefits in terms of bleeding or pain or any of the other reasons for early discontinuation. None of the trials that reported events at insertion found one IUD easier to insert than another or caused less pain at insertion. There is no evidence that uterine perforation rates vary by type of device. There are minimal randomized data on IUD use in nulliparous women. CONCLUSIONS: TCu380A and TCu380S appear to be more effective than other IUDs. No IUD showed consistently lower removal rates for bleeding and pain in comparison to other IUDs. There is no evidence that any particular framed copper device is better suited to women who have not had children.

Worldwide use of intrauterine devices for contraception.

The intrauterine device is the most widely used reversible method of contraception in the world today, particularly in developing countries where it is used by 14.5% of women of reproductive age. In the developed world, this percentage is only 7.6%. There are marked regional differences with the highest use in Eastern Asia and the lowest in North America. Such differences between regions and countries can be explained by a number of factors at the individual, service delivery, program and policy levels. The situation in seven countries is briefly described to illustrate this and to conclude that this method of contraception is largely underutilized in many parts of the world, where it could play a significant role in improving women's health.

Effectiveness and acceptability of vitamin E and low-dose aspirin, alone or in combination, on Norplant-induced prolonged bleeding.

A study (ISRCTN 77665712) was undertaken to test the effectiveness and the acceptability of vitamin E and low-dose aspirin, alone or in combination, as treatment for prolonged vaginal bleeding induced by Norplant. A total of 486 Norplant users who were requesting treatment for bleeding lasting longer than 7 days were enrolled in five centers: Beijing, China; Jakarta, Indonesia; Santiago, Chile; Santo Domingo, Dominican Republic; and Tunis, Tunisia. They were randomized to one of four different 10-day oral treatments: 200 mg vitamin E daily, 80 mg aspirin daily, both or a placebo. Treatment packs were designed to ensure blinding of both the subjects and the clinical staff. Neither vitamin E nor low-dose aspirin nor their combination was found to have any effect on reducing the length of the bleeding episode for which treatment was taken or on the vaginal bleeding patterns these women experienced during the year of follow-up.

Effect of intermittent treatment with mifepristone on bleeding patterns in Norplant implant users.

A double-blind, placebo-controlled, randomized trial, was carried out in 120 Norplant users to evaluate the effect of mifepristone, 100 mg/day administered for 2 consecutive days every 30 days, on the vaginal bleeding pattern. Treatment was given from months 2-7 of implant use. Volunteers recorded bleeding and spotting days, during treatment and for the ensuing 6-month period. During treatment, women on mifepristone recorded the same frequency of bleeding/spotting episodes but significantly less prolonged bleeding episodes than placebo controls (mean +/- SD: 11 +/- 3 vs. 22 +/- 23 days) and their total number of bleeding days was 35% lower than in the placebo group. After the end of mifepristone use, bleeding patterns were similar in both groups. One pregnancy occurred in the mifepristone-treated group, in month 6 of treatment, the outcome was a healthy male baby. We conclude that intermittent administration of mifepristone can offer a clinically significant improvement of the vaginal bleeding pattern in Norplant users.