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A diagnostic study to evaluate the prevalence of clinical and non-clinical delivery of Norplant in the Indonesian family planning program.
In: Operations research family planning database project summaries, [compiled by] Population Council. New York, New York, Population Council, 1993 Mar.  p. (INS-14)Indonesia's national family planning (FP) program constituted the largest introduction of Norplant in the world; the first 5-year removals were scheduled for late 1991. The ANE operations research/technical assistance (OR/TA) project is conducting a use dynamics study to examine Norplant's use in the field. To prepare for that study and to get early information on program functioning, the National Family Planning Coordinating Board (BKKBN) and the Population Council, in conjunction with Andalas University in West Sumatra and BKS-PENFIN in West Java, undertook a diagnostic study in the fall of 1991 at a cost of US $6,250. Field teams investigated 6 clinics in each of the 2 provinces, interviewing service providers and examining records. 10 acceptors from each clinic (total 120) were visited in their homes to determine the feasibility of locating them and whether they were still using implants. About 70% of acceptors in each province had been served by nonclinical sources, either "safaris" or mobile teams. The 4-year life-table continuation rate was 78%. No written information specifically devoted to Norplant was available to providers or to clients. All physicians and nurse-midwives, as well as many nurses, had some training in Norplant insertion and removal. Contrary to expectation, clinical staff, records, and logistics all seemed generally adequate for 5-year removal. Results were used to address issues raised, and a final report has been completed. The feasibility of the use-dynamics study was confirmed. Available records generally matched official records, although significant gaps were found. The study allowed questionnaires and field procedures to be refined.
[Contraception via a vaginal hormonal ring] Kontratseptsiia posredstvom vlagalishten khormonalen prusten.
AKUSHERSTVO I GINEKOLOGIIA. 1991; 30(1):49-52.Research on the hormonal vaginal ring began in the US in 1973. Its prototype with a diameter of 55 mm releasing in even doses small amounts of hormone was introduced 17 years later. Its high effectiveness with a failure rate of 3-4 pregnancies/100 woman use years is similar to that of most IUDs. The first type contains a combination of estrogen-gestagen consisting of levonorgestrel and 17-beat-estradiol as in oral preparations. It has to be used from the beginning of the menstrual cycle for 3 weeks and removed for 1 week. The second one, devised by a special program of WHO, contains gestagen only in the form of levonorgestrel (LNG) releasing 20-25 mcg of LNG daily. The third type contains progesterone only which is suitable for use by lactating women, as the progesterone eventually absorbed in the maternal system does not pose any risk to the nursing child. At present its effectiveness is being tested, and then its practical application will be examined. The introduction of the prototype was delayed by 2 years when initial investigations showed that the substance used for polymerization of the plastic used for the vaginal ring was carcinogenic, however, this was refuted in subsequent investigations. The vaginal ring is already sold regularly in Great Britain and in some western European countries. This new method allows doctors to provide an alternative contraceptive in addition to the existing ones.
In: Issues in reproductive technology I: an anthology, edited by Helen Bequaert Holmes. New York, New York, Garland Publishing, 1992. 11-30. (Garland Reference Library of Social Science Vol. 729)The progestin, levonorgestrel, suppresses ovulation and thickens the cervical mucus. The 1-year pregnancy rate is 0.2/100 users and the 5-year rate is 3.9/100 users. Contraindications of Norplant include abnormal bleeding, cardiovascular conditions, liver tumors, and breast cancer. The most frequent side effect is changes in bleeding patterns. A main concern of women's health advocates is that women are dependent on the medical establishment for insertion and removal of Norplant which affects the provider-client relationship. Family planning programs that do not recognize a woman's right to free choice of existing contraceptives and her right to have Norplant removed at any time may abuse Norplant. Health workers still do not know the long term effects of Norplant and Norplant's effect on the fetus in case of method failure or insertion while pregnant. Most acceptability studies occurred at university-based health clinics or at clinics in urban areas. The clinic environment may affect women's answers. These studies should occur in the community and home of users and nonusers. Another bias of these studies was clinic staff chose women who would tend to continue using Norplant. Thus subjects were not representative of the population. Researchers did not attempt to understand the women's perception of reproduction physiology and mode of action, the women's cost benefit analysis used to determine what method to use, or the consequences of menstruation changes. They also did not report on the information women received about contraceptive choices. The issue of abuse has arisen in Kansas where a state legislator proposed paying any mother on welfare US$500 if she uses Norplant. In California, a judge ordered a woman convicted of child abuse to use Norplant after release from jail and throughout her probation period.
ADVANCES IN CONTRACEPTION. 1990 Sep; 6(3):169-76.Clinical trials of vaginal rings containing progestins or ethinyl estradiol and progestins by WHO, the Population Council and private firms are reviewed. Contraceptive steroids can be formulated into Silastic vaginal rings because they are released continuously from this material (zero-order kinetics). Vaginal rings have the advantage of avoiding the 1st pass effect on the liver, as well as self- administration, unrelated to the timing of coitus and regulation of withdrawal bleeding with removal for 7 days per cycle. The shell vaginal ring, with an inert core, a layer of Silastic containing the progestogen, and an outer Silastic layer is designed to regulate release by the thickness of the outer layer. The WHO tested rings releasing 200 mcg norethisterone/day resulting in too many menstrual side effects; and 50 mcg/day with too high a failure rate. A ring releasing 20 mcg levonorgestrel is expected to perform well. The Population Council designed rings releasing 152 mcg ethinyl estradiol and 252 mcg levonorgestrel, and 183 mcg ethinyl estradiol and 293 mcg levonorgestrel. These resulted in pregnancy rates of 2/100 woman years, and continuation rates of 50%, but unacceptably adverse lipid effects. Women discontinued for vaginal symptoms. Compared to a similar combined oral pill, the rings offered no advantage. WHO subsequently introduced a ring releasing 20 mcg levonorgestrel: efficacy was 3.8 and continuation over 50%. A new segmented ring with desogestrel is causing fewer androgenic effects and bleeding complaints. Another ring in current trials gives off 120 mcg desogestrel and 30 mcg ethinyl estradiol with no pregnancies and good acceptability in 100 women to date. Availability of Silastic material and quality control in manufacture are seen as obstacles to overcome for mass production of these vaginal rings.
A randomized comparative study of interval insertion of three intrauterine devices: the copper T 220c, the Nova T and the WHO levonorgestrel 2 ug IUD.
[Unpublished] 1985 May. 5 p. (Project: 82901)The objective is to compare the effectiveness and acceptability of 3 IUDs inserted in 300 health women, aged 24-38. All have had at least 1 full-term delivery. Subjects were randomly allocated to 1 of the 3 IUDS: the Copper T 220C (Tcu 220c), the Nova T, and the World Health Organization levonorgestrel 2 ug IUD. Insertion was done from the 3rd to the 5th day of menstruation between Feb. and Sept. 1984 and followed up at 48 hours, 3, 6, 12, and 24 months after IUD insertion. 12 month data was collected for cumulative rates, based on life table procedures and analyzed with log-rank test. There was no loss to follow up and no insertion failure. All levonorgestrel IUDs have been removed because the levonorgestrel-releasing IUD has a relatively high risk of ectopic pregnancy. The use-related discontinuation rates of Tcu 220c, Nova T, and levonorgestrel IUD during 12 months of use, were 11.1, 2.4, and 12.7, respectively. The difference between Tcu 220c and Nova T were statistically significant (p.<0.01). The continuation rates of Tcu 220c, Nova T, and levonorgestrel during 6 months of use were 94.0, 99.0, and 96.0, respectively. During 12 months of use, they were 88.9, 97.6, and 87.3 respectively. 1 ectopic pregnancy occurred with the levonorgestrel IUD after 7 months of use. No pregnancy occurred in Nova T users. The pregnancy rates of Tcu 220c and levonorgestrel IUD during 12 months of use were 1.0 and 1.3, respectively. Removal rates for bleeding with Tcu 220c and levonorgestrel IUD during 12 months of use were 3.1 and 1.0, respectively. The removal rate for pain with Tcu 220c during 12 months of use was 2.0. The duration of bleeding and spotting with 3 IUDs, 3, 6, 9, and 12 months of use are illustrated. Preliminary results show that the Nova T is superior to Tcu 220c and levonorgestrel IUDs. Expulsion is the main event in both Nova T and Tcu 220c. More attention should be paid to the insertion technique. The duration of bleeding and spotting of levonorgestrel IUD were longer in the last 3 months after insertion, but was shortest at 1 year of use when compared with Tcu 220c and Nova T.
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)
Effective interception with the levonorgestrel-20-IUD contrarily to WHO advocated Lng-2-microdose IUD. Reply to letter to the editor [letter]
CONTRACEPTION. 1988 Jun; 37(6):644-6.This letter is a response to Professor Haspels' letter criticizing the World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction's clinical study of a 20 mcg microdose levonorgestrel IUD for Contraception (Contraception 1987;35: 363-79). The Population Council's International Committee for Contraceptive Research was provided with the results of the study prior to publication. The feasibility of an IUD that released a dose of progestational steroid that was pharmacologically active only on the endometrium was confirmed in a study conducted between 1980-1982 in 7 centers, only 3 of which were in developing countries. There was no evidence of effects on ovulation and no ectopic pregnancies in this study. The study itself resulted in only 8 ectopic pregnancies (6 with the levonorgestrel device and 2 with copper devices) out of 17,064 woman-years of experience. Nevertheless, the study was terminated and the results published. The polymeric delivery system used in the 2 mcg levonorgestrel IUD had undergone extensive animal toxicological studies in the US and the UK before human use. Moreover, the ethical acceptability of the study was approved by the World Health Organization as well as by local institutional ethic committees and appropriate national authorities.
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.
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)
JOURNAL OF STEROID BIOCHEMISTRY. 1979 Jul; 11(1B):461-7.This report succinctly summarizes Phase I and II clinical trials of intravaginal and intracervical delivery systems for fertility control agents (both steroidal and spermicidal) performed at World Health Organization (WHO) Centres internationally. The WHO Special Programme has conceived of and developed a number of vaginal rings (silastic), which are capable of achieving constant release rates of progestogenic steroid for periods of 90 or more continuous days of use. The local administration rules out the possibility of systemic side effects while the constant release is capable of inhibiting sperm migration through the cervical mucus efficacy of these devices incorporating norethisterone, levonorgestrel, and progesterone is in progress. The vaginal ring has also been incorporated with nonoxynol-9, a potent spermicidal agent. Constant daily release of this spermicidal agent also inhibits sperm migration in the cervical mucus, and use-effectiveness studies are underway. An inert intracervical device, designed and manufactured by WHO, is described (figures depict its manufacturer), and though it is suitable for constant release contraception, no such studies have been performed as yet. Numerous tables report particular release rate data for the vaginal rings impregnated with various dosages of progestogen or spermicide.
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.
Contraception. 1982 Mar; 25(3):231-41.A randomized, controlled, clinical trial comparing 6 combined oral contraceptives (OCs) with 50 mcg or less of ethinyl estradiol was undertaken in 10 WHO Collaborating Centers for Clinical Research in Human Reproduction. A total of 2430 women entered the trial and were observed for 28,077 woman-cycles. All low-dose combined OCs demonstrated equivalent efficacy with 1-year pregnancy rates of 1-6%. However, discontinuation rates for medical reasons differed significantly between the treatment groups with the preparation containing 20 mcg ethinyl estradiol and that containing 400 mcg norethisterone acetate being associated with higher discontinuation rates due to bleeding disturbances. Even among the preparations which did not differ in discontinuation rates, the reasons for discontinuation did differ. Women receiving norethisterone preparations tended to discontinue because of bleeding disturbances while those receiving the levonorgestrel-containing preparations tended to discontinue because of complaints of nausea and vomiting. (author's)