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Effective interception with the levonorgestrel-20-IUD contrarily to WHO advocated Lng-2-microdose IUD [letter]
CONTRACEPTION. 1988 Jun; 37(6):643.The World Health Organization's Special Program of Research, Development, and Research Training in Human Reproduction has investigated microdose administration of levonorgestrel to the uterine cavity and concluded that this approach is not safe or effective. In contrast to the excellent results obtained with 20 mcg of levonorgestrel release per 24 hours, the results of application of only 2 mcg release per 24 hours have been disappointing. There was a 6.7 increased relative risk of ectopic pregnancy with the levonorgestrel 2 IUD compared with the copper IUD, making this an unacceptable form of fertility control. On the other hand, the 12-month pregnancy rate for the levonorgestrel 20 IUD is 0.1/100 woman and the 12-month continuation rate is 80%. Removal rates for menstrual problems with this IUD are only 7.5%, and blood hemoglobin concentrations actually increase among users of the levonorgestrel 20 model.
FERTILITY AND STERILITY. 1986 Oct; 46(4):626-30.In a phase 3 clinical trial sponsored by WHO Special Program of Research in Human Reproduction, contraceptive effectiveness and adverse effects were analyzed in 108 women who used the levonorgestrel-releasing vaginal ring. This delivery system releases levonorgestrel at a constant rate in a low dose (20 + or - 3.5 mcg/24 hours) sufficient for contraception without necessarily inhibiting ovulation. 1-year cumulative net rates per 100 women were: pregnancy, 3.7; expulsion, 4.6; use-related discontinuation, 26.9; and continuation, 71.2. Menstrual disturbance (e.g., intermenstrual bleeding, prolonged menstrual flow, amenorrhea) was the main adverse effect and the most common reason for discontinuation. Menstruation disturbances occurred in 45% of the cycles during the 1st month of use, but decreased gradually to 12.5% during the 12th month. Expulsions, which occurred 7.7% of the 963 cycles observed, generally took place during urination or defecation. The duration of menstrual flow was prolonged from 4 to 9 days before insertion to 6.9 after insertion. However, the menstrual blood loss gradually declined after insertion and the hemoglobin concentration was significantly increased in the 6th and 12th months after insertion (p. < 0.05). Analysis of E2 and P in 35 of the treatment cycles in this study indicated that 48.5% were ovulatory. An advantage of the low-dose levonorgestrel-releasing vaginal ring is that there are no significant changes in lipid parameters. Although the high-dose levonorgestrel and estradiol-releasing ring developed by the Population Council is associated with fewer bleeding problems, the low-density and high-density lipoprotein ratio is significantly elevated, with possible implications for the risk of cardiovascular disease. The WHO vaginal ring is likely to be an effective alternative for women who cannot use other currently available contraceptive methods.
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.