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World Health Organization evaluates NORPLANT subdermal implants as effective, reversible, long-term contraceptive. News release.
New York, Population Council, 1985 Feb 22. 5 p.A World Health Organization (WHO) review of animal and human data on Norplant subdermal implants, convened at the request of the United Nations Fund for Population Activities, has determined that this contraceptive system is an "effective and reversible long term method of fertility regulation" and recommended that it be made available through family planning programs. George Zeidenstein, president of the Pouplation Council, which developed the Norplant system, has termed the WHO report "a giant step toward worldwide acceptance and availability." So far, extensive clinical trails have noted no adverse side effects of this contraceptive system, and animal studies on levonorgestrel suggest the drug is safe for use in humans. Clinical trial data on more than 4000 women have indicated continuation rates of 60-95% at the end of the 1st year and about 50% at the end of the 5th year. The annual pregnancy rate is 0.2-1.3/100 women over a 5 year period. Disturbance of the menstrual cycle, including increased frequency and number of bleeding days as well as irregular bleeding or spotting, occurs in the majority of women who use this method; however, bleeding problems tend to diminish with increased duration of use. The Norplant implant system is particularly suitable fo r women who seek extended contraceptive protection but either do not wish to undergo sterilization or who desire a child in the future. Norplant is currently a vailable in Finland and has just been granted registration in Sweden. Over the next 2 years, regulatory approval will be sought in 40 additional countries including the US, where the Norplant system is in clinical trials at 3 sites.
Outlook. 1985 Mar; 3(1):7-8.The World Health Organization (WHO) consultation convened in October 1984 the Special Programme of Reasarch in Human Rreproduction concluded that Norplant provides effective and reversible longterm contraception and should be available in family planning programs for women desiring longterm contraception. The Norplant implant systgem consists of 6 silastic capsules each containing 36 mg of levonorgestrel which is slowly released into the bloodstream. The implants can be left in place for up to 5 years or removed at any time. The consultation report considered the research data adequate to conclude that the method is safe for human use. Acceptability apperas to be high: 1st year continuation rates of 80-90% are roughly equivalent to those of the IUD, and continuation at the end of 5 years is about 50%. Bleeding irregularities are a common side effect, but heavy and prolonged menstrual bleeding is infrequent. The constant slow release of levonorgestrel minimizes the common side effects of contraceptive steroids, and the system exposes the body to less than 100 mg of levonorgestrel over 5 years. Since the method is new and not in widespread use, there have been few studies on longterm use or rare side effects, prompting the WHO consulatation to recommend "appropriate surveillance activities to evaluate its long-term safety." Additional research was also recommended on the effect of the implants on lactation and on the growth and development of children exposed to levonorgestrel in breastmilk. The consultation report pointed out the need for clinic facilities for insertion and removal and for adequate training of providers before introduction of the method into a program. An international pharmaceutical company based in Finland has been licensed by the Population Council, the developer of Norplant, to manufacture and distribute the implants. The Swedish National Board of Health and Welfare has also approved the Norplant system for contraceptive use in Sweden.
In: Zatuchni GL, Goldsmith A, Shelton JD, Sciarra JJ, ed. Long-acting contraceptive delivery systems. Philadelphia, Pa., Harper and Row, 1984. 1-19. (PARFR Series on Fertility Regulation)Depo-Provera (depomedroxy-progesterone acetate, or DMPA) and NORPLANT (the Population Council's registered trade name for subdermal implants) are focused on in this literature review. Over the past 17 years, more than 1 million individual doses of Depo-Provera have been supplied in Thailand. Currently 6,000 women a month use the method. Depo-Provera has proved outstandingly successful in Bangladesh for years. The basic disadvantage of long-acting steroid systems is that return to fertility is slow and unpredictable. Other disadvantages include menstrual distrubances and weight gain. Acceptability of injectable contraceptives has been studied primarily by the World Health Organization (WHO). In 1976, the Task Force on Acceptability of Research and Family Planning explored preferences among 3 routes of contraceptive administration: 1)oral; 2)intravaginal; and 3)injection. The study was conducted in Indonesia, Korea, Pakistan, and Thailand. Although the oral route was generally preferred by most women, many respondents still chose the injectable. A WHO III multicentered trial comparing the use, effectiveness, side effects and bleeding patterns of Depo-Provera and norethisterone enanthate (NET-EN) was terminated after only 1 year because of excessively high pregnancy rates with NET-EN. A total sample of about 250 women in Manila and Alexandria were interviewed. Results indicated that the 2 most important considerations were effectiveness and menstrual bleeding. Depo-Provera did not affect menstruation. Various types of subdermal implants releasing a contraceptive Silastic implant, is placed beneath the skin of the forearm or upper arm and provides 5 or more years' protection against pregnancy. The 6 capsules are not biodegradable and require surgical removal under local anesthesia.
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.
Steroids. 1983 Mar; 41(3):243-53.The great demand for improved longacting injectabe steroid contraceptives, particularly in developing countries, and the relative lack of interest from the pharmaceutical industry to develop such products stimulated the World Health Organization to launch a synthetic and screening program to find improved, safe, and acceptable injectable preparations. More than 210 esters of norethisterone (17alpha-ethynyl-17beta-hydroxyestr-4-en-3-one) and levonorgestrel (D-(-)-13beta-ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one) have been prepared in university-based research laboratories situated mainly in developing countries, and then screened by NICHHD in animal models. The following 3 compounds levonorgestrel butanoate, cyclopropylcarboxylate, and cyclobutylcarboxylate, proved to be particularly longacting when administered as microcrystalline suspensions. The overall strategy of this research and development program is described. (author's modified)
In: Goldsmith A, Toppozada M, ed. Long-acting contraception. Chicago, Illinois, Northwestern University, Program for Applied Research in Fertility Regulation [PARFR], 1983. 137-46.The characteristics and clinical performance of subcutaneously and vaginally implanted vaginal rings, under development for the past 15 years, are reviewed. This development has been restricted to public sector agencies, including the World Health Organization (WHO) and the Population Council, reflecting the lack of interest of the pharmaceutical industry in this area. Currently, only 1 progestogen-only releasing device is under development. The ring, which releases 20 mcg/day of levonorgestrel, produces plasma concentrations averaging 0.528 pmoles/ml, with a 20% decline in these concentrations 90 days after insertion. Ovulation was not inhibited in 90% of subjects studied in clinical trials, although inhibition of sperm transport in cervical mucus was noted in 85%. A WHO-sponsored Phase I trial of vaginal rings releasing progesterone, norethisterone, and levonorgesterel resulted in abandonment of development of the 1st 2 steroids. No pregnancies were noted in 360 woman-months of use of levonorgestrel-releasing rings. Phase II studies with these rings produced encouraging results, and results of Phase III multicenter clinical evaluations should be available by late 1983. In an attempt to improve bleeding performance, rings capable f releasing both an estrogen and a progestogen have been develeped under the auspices of the Population Council. 2 progestational agents--progesterone and levonorgestrel--coupled with estradiol have been used in these studies. Results with the levonorgestrel-estradiol ring have been most promising. A clinical trial involving 1147 users compared the pregnancy rate obtained with 2 such rings, 1 with a 58 mm outer diameter and 1 with a 50 mm diameter, to that with a low lose oral contraceptive (OC) containing 150 mcg levonorgestrel and 30 mcg ethynilestradiol. The 58 mm diameter ring produced only 5 pregnancies in 1 year of of use, compared with 9 pregnancies with the 50 mm ring and 10 pregnancies with the OC. Tests in both urban and rural areas of 2 Latin American countries found that 3-12.5% of total acceptors accepted the rings, with higher percentages in the rural areas. Acceptability fell after 6 months of use and recovered in the 2nd year. Since both the ovulation inhibiting discontinuous use ring and the low dose continuous use device are at the Phase III level, this new form of contraception may be available within the next few years.