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Comparison of three single doses of mifepristone as emergency contraception: a randomised controlled trial.
Australian and New Zealand Journal of Obstetrics and Gynaecology. 2005 Dec; 45(6):489-494.This is an analysis of the Australian component of a large World Health Organization multicentre dose-finding study of mifepristone for emergency contraception and the first clinical study of this controversial drug in Australia. The aims were to compare the effectiveness and side-effects of three single doses of mifepristone taken within 120 h after unprotected coitus as emergency contraception. Design: Double-blind, randomised controlled trial. One hundred fifty healthy women with regular menstrual cycles who requested emergency contraception. Participants were allocated randomly to one of the three doses (10, 50 and 600 mg). The primary outcome was confirmed pregnancy, and secondary outcome measures included side-effects and delay in the onset of the next menses. Pregnancy rates for mifepristone 10, 50 and 600 mg were 2.0, 2.1 and 2.1%, respectively, with no significant difference between groups. No major side-effects occurred, except an unpredictable delay in the onset of the next menses. Mifepristone 600 mg caused a significantly longer delay in the onset of the next menses than either the 10 or the 50 mg dose. Lowering the dose of mifepristone from 600 to 10 mg did not significantly impair its effectiveness as an emergency contraceptive, and caused less delay in the onset of the next menses. Therefore, a dose as low as 10 mg may be preferable to 600 mg for emergency contraception. This is very much lower than the dose required to terminate a pregnancy. (author's)
Contraception. 1984 Dec; 30(6):505-22.The World Health Organization (WHO) conducted a randomized comparative trail of th effects of hormonal contrception on milk volume and infant growth. The 341 study participants, drawn from 3 obstetric centers in Hungary and Thailand, were 20-35 years of age with 2-4 live births and previous successful experience with breastfeeding. Subjects who chose oral contraception (OC) were randomly allocated to a combined preparation containing 150 mcg levonorgestrel and 30 mcg ethinyl estradiol (N=86) or to a progestin-only minipill containing 75 mcg dl-norgestrel (N=8). 59 Thai women receiving 150 mg depot medroxyprogesterone (DPMA) intramuscularly every 3 months were also studied. An additional 111 women who were using nonhormonal methods of contraception or no contraception served as controls. Milk volume was determined by breast pump expression. No significant differences in average milk volume were noted between treatment groups at the 6 week baseline visit. However, between the 6th and 24th weeks, average milk volume in the combined OC group declined by 41.9%, which was significantly greater than the declines of 12.0% noted in the progestin-only group, 6.1% among DMPA users, and 16.7% among controls. The lower expressed milk volume among combined OC users did not impair infant growth. No significant differences were observed between treatment groups in terms of average infant body weight or rate or weight gain. Users of combined OCs may have compensated for their decreased milk volume by providing more extensive supplementary feeding or more prolonged suckling episodes. These results suggest that the estrogen content of combined OCs adversely affects the capacity of the breast to produce milk; thus, family planning programs should make nonestrogen-containing methods available to breastfeeding mothers. Although no effects on infant growth were noted in this study, the possibility of such efects cannot be excluded in populations where infant growth largely depends on the adequacy of unsupplemente d lactation.
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.
JOICFP NEWS. 1998 May; (287):5.The Central Pharmaceutical Affairs Council of Japan's Ministry of Health and Welfare recommended that the licensing of the low-dose oral contraceptive pill be postponed until further studies are conducted into the relationship between the pill and cervical cancer, the release of endocrine-disrupting chemicals into the environment from the urine and feces of women using the pill, and possible health problems in children of mothers who have taken the pill before pregnancy. The government of Japan decided in March to indefinitely postpone licensing of the low-dose oral contraceptive pill. Women, the Family Planning Federation of Japan, and other supporters in Japan are now working to educate the public on the issue and pressure the government to speed authorization. Japan is the only industrialized country in the world which does not provide access to the pill. Without the low-dose oral contraceptive pill, women in Japan practically have no effective female method of contraception since neither implants, injectables, nor copper IUDs are authorized. Not only does the government's position compromise the reproductive rights and health of women in Japan, it also runs counter to Japan's status as one of the largest donors to international population and reproductive health programs.
[Sexual abstinence or thrombosis? Comment on the controversy regarding the "third generation pill"] Enthaltsamkeit oder Thrombose? Stellungnahme zur Kontroverse um "Pille der dritten Generation".
FORTSCHRITTE DER MEDIZIN. 1995 Nov 30; 113(33):18, 20.In October 1995 the WHO published the alarming results of an international study about oral contraceptives (OCs) and the risk of venous thrombosis stating that with the use of the third generation of OCs or micropills containing gestodene and desogestrel the risk increases twofold compared with OCs containing other gestagens. However, the Zurich discussion group, composed of German and Swiss hormone researchers, declared that this statement should be taken with a grain of salt. The study reported that 3 cases of thrombosis occur for 100,000 woman years when no OCs are used. When OCs without the above two gestagens are used the incidence of thrombosis increases to 8 cases/100,000 woman years. With the use of these micropills the incidence rose to 17 cases/100,000. The experts interpretation of the differentials was that the common risk factors for thrombosis (obesity, smoking, age, and duration of OC use) were not sufficiently taken into consideration. The original higher dose OCs already produced side effects early on, such as thrombosis, stroke, and heart infarction. Therefore, in the late 1980s the introduction of the new generation of OCs with lower doses seemed to be a welcome solution. The micropill, Femovan by Schering, was put on the market containing .03 mg of ethinyl estradiol (EE) and .075 mg of gestodene, a synthetic, very effective gestagen. The Organon Company introduced another preparation (Marvelon) that contained the same dose of EE and .15 mg of desogestrel. The considerable attention to the putative higher risk of thrombosis posed by these agents was not shared by the European Drug Commission, which did not see any reason for removal of these OCs from the market. The third generation OCs also provide benefits: reduction of bleeding anomalies and cardioprotective effects. Even the increased thrombosis risk is significantly lower than the thrombosis risk posed by pregnancy, delivery, and puerperium.
OUTLOOK. 1990 Jun; 8(2):7-9.This article summarizes the most recent data on WHO's multicenter clinical trial test of the low dose progestin-releasing vaginal ring as an effective contraceptive for women. The study involved 1005 women aged 19-34 and was carried out from 1980-86 at 19 centers in 13 countries, including 9 developing countries. The overall findings on vaginal ring use included: the ring's effectiveness was comparable to oral contraceptive (OC) effectiveness, pregnancy rates increased with increasing body weight, about 1/2 of the users had discontinued the ring by 1 year, the ring disrupted menstrual bleeding patterns in about 1/2 of all users, and about 1/4 of all users expelled the ring at least once but most continued to use it. The irregular bleeding pattern was the main reason for discontinuation. Part of the reason for having different ring contraceptive effectiveness in different countries could be due to differing average weights of the women. Increasing risk of expulsion was directly related to increasing age by approximately 3% with each year of age. For effective use of 90-day low-dose levonorgestrel-releasing vaginal ring, appropriate clients should have the following: a dislike for inserting and removing vaginal devices, low weight, counselling on potentially irregular bleeding, and counseling on how to deal with an expulsion. (author's modified)
[Unpublished] 1987 Jun.  p.To increase knowledge and proper use of low-dose oral contraceptives and increase availability of affordable contraception for low-income populations in the Dominican Republic, Profamilia (an IPPF affiliate) launched a communications/promotional campaign for Microgynon aimed at men and women under age 35. While strengthening Profamilia's marketing and organizational capabilities so that the program could be maintained without donor subsidies, the Profamilia name was used to communicate the idea of quality at low price. The message that Microgynon is a safe, effective, easily used, temporary method of birth control was relayed through a television commercial aired in 1986; through press releases; on display posters, stickers, matchbooks, memo pads, and bag inserts distributed to pharmacies; by educational/promotional meetings with the medical community; and by orientation sessions with pharmacy employees. Schering Dominica's sales network placed Microgynon in 83% of pharmacies in the Dominican Republic. It was priced significantly below comparable products. Of 500 randomly selected residents, 68% remembered seeing the television commercial. In interviews with 252 Microgynon purchasers, 65% said that they had started using Microgynon after the television advertising campaign. The campaign was successful in reaching the target group of women.
IPPF MEDICAL BULLETIN. 1987 Apr; 21(2):1-2.Within the past 25 years, steroidal preparations have become available that allow the user contraceptive protection over extended periods of time. There are only 2 injectable preparations presently used at all widely within family planning programs throughout the world: 1) depot medroxyprogesterone acetate (DMPA), and 2) norethisterone enanthate (NET-EN). 1 of the major side effects of progestagen-only contraception has been disruption of normal menstrual bleeding, giving rise to both irregular bleeding and amenorrhea. Several extensive reports on the clinical use of monthly injectables appeared in 1970, but few studies have been reported subsequently. In response to the demand from certain populations to have safe, well-investigated, once-a-month injectable contraceptives with high efficacy and little menstrual bleeding disturbance, the World Health Organization's (WHO) Special Programme of Research in Human Reproduction developed a strategy for the development of a once-a-month contraceptive which involves: 1) the assessment of use-effectiveness and side-effects of HRP102 (NET-EN, 50 mg., plus oestradiol valerate, 5 mg) and Clyloprovera (DMPA, 25 mg., plus estradiol cypionate, 5 mg.); and 2) the optimum improvement of these 2 combined formulas by reduction of the progestagen content. Results from a pharmacokinetic/pharmacodynamic study show that many of the women receiving reduced progestagen dose preparations ovulated during the 3rd treatment month; thus the 2 original preparations, Cycloprovera and HRP102 appear to be the optimal formulations for these combinations of steroids. Plans are being developed to make 1 or both of these available for introduction into certain family planning programs in developing countries early in 1988.
Outlook. 1984 Dec; 2(4):4.Recent recommendations and statements issued by the US Food and Drug Administration (FDA), the Planned Parenthood Federation of America (PPFA), and the International Planned Parenthood Federation (IPPF) on the prescribing of oral contraceptives (OC) are briefly summarized. These statements reflect a growing concern about the effect of OCs on lipid metabalism. The FDA recommended prescribing OCs with the lowest effective dosage levels of progresterone and estrogen. According to the FDA's Fertility and Maternal Health Drugs Advisory Committee, OCs containing high doese of estrogens and progestins increse the risk of vascular disease. The National _medical Committee of PPFA recommede that the prescribing of high dosages of progestogens should be avoided whenever possible. The committee identified maximum dosage levels for progestogens. These maximum dosages were 1 mg for norethindrone, .5 mg for norethindrone acetate, 1 mbg for ethynodiol diacetate, .3 mg for norgestrel, and .15 mg for levonorgestrel. The committee noted that if progestogen levels are too low, breakthrough bleeding and contraceptive failure are more likely to occur. The International Medical Advisory Panel of IPPF recently issued a statement on lipid changes associated with progestogens. The panel noted that recent studies have shown that progestogens are associated with a decrease in high density lipoprotein cholesterol and an increse in low density lipoprotein cholesterol; however, the panel also noted that the subjects in the studies were given high doses of progestogens and that the studies were conducted in developed countries with high rates of obesity, alcohol consumption, and smoking.
JOURNAL OF BIOSOCIAL SCIENCE. 1977; (Suppl 4):113-20.WHO (World Health Organization) is planning to undertake 3 different studies concerning lactation and contraception. These studies will attempt 1) to determine the effects, if any, of steroid contraceptives on lactation; 2) to identify and quantify any forms of steriods which may appear in the breast milk of mothers who use steroid contraceptives; and 3) to identify parameters which would help nursing mothers pinpoint ovulation onset. There is considerable controversy among scientists concerning the affects of steroid contraceptives on lactation. WHO proposes to undertake a prospective study assessing the effect of various typis of combined and progestogen only oral steroids as well as injectable preparation on lactation among matched control groups in a number of countries. An effort will be made to minimize an many extraneous variables as possible and to employ uniform procedures and methods in all the countries. In reference to the 2nd study, there is considerable controversy concerning the possible transfer of steroids to maternal breast milk and about the subsequent effect of these steroids on infants who ingest the milk. The WHO study will seek to determine if steroids or their metabolites are present in the breast milk of nursing mothers who take steroid contraceptives. In reference to the 3rd study, if reliable indicators of ovulation resumption among postpartum women can be identified, efforts will be made to develop test kits for home use by nursing mothers.
Bibliography on human reproduction, family planning and population dynamics: annotated articles and unpublished work in the South-East Asia Region: steroid contraception (including review of current status).
New Delhi, India, World Health Organization, Regional Office for South-East Asia, November 1974. (Special Supplement No. 1) 77 pThis annotated bibliography lists pamphlets, articles, and studies on combined contraceptives; low dose; injectables; long-acting; implants; postcoital; metabolic effects; lactation; long-term effects; biologic effects; metabolism; mode of action; contraception in the male; field studies; use in gynecological disorders; and works in progress on aspects of steroid contraception in centers in the South-East Asia Region. Sample titles are "Inhibition of ovulation for control of conception" and "Action of cyproterone acetate on male reproductive functions." A review of current status of steroid contraception includes a brief history; description of chemical composition; rates of effectiveness; side effects; clinical aspects; and return to fertility. Steroid releasing vaginal rings, IUDs, and intracervical devices are also described.