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This controlled cohort study aimed to evaluate the safety and efficacy of Norplant contraceptive implants in developing countries. Women initiating Norplant implants were index subjects and women initiating intrauterine devices (IUDs) or surgical sterilization were controls. Consenting participants at 32 clinics in eight developing countries were admitted and followed-up every 6 months for 5 years. Major and less serious health events during follow-up were recorded. Incidence rate ratios of health events adjusted for clinic were estimated for initial and current method use. This paper reports non-reproductive health events. The study involved 7,977 women initiating use of Norplant, 6,625 of IUD, and 1,419 of sterilization. Five years follow-up was completed for 94.6% of the women. The study accumulated 78,323 woman-years of observation. The initial method chosen accounted for 84.4% or more of observed woman-years in users of Norplant, IUD, or sterilization. Twenty-two of the recorded 34 deaths were due to accidents, suicide or homicide. Few deaths or major health events were due to cancer or acute cardiovascular diseases and were not associated with the contraceptive method used. The incidence rates of major health events were low and with two exceptions, there was no significant excess risk of serious morbidity for Norplant users compared with controls; among Norplant initiators gallbladder disease occurred at an incidence rate of 1.5 per 1,000 woman-years and was weakly associated with use of Norplant (rate ratio 1.52 [95% C.I. 1.02, 2.27]). For current Norplant users compared to controls, the rate ratio of a combined variable of hypertension and borderline hypertension was significantly elevated (1.81, [1.12, 2.92]). The occurrence of less serious health events was also low and several of them were significantly more often reported among Norplant users. Headache-migraine, weight gain, mood disturbances, pruritus, eczema, and acne had incidence rates among Norplant users of 11.5, 4.5, 2.8, 1.5, 1.4, and 0.9 per 1,000 woman-years, respectively, and were significantly higher than in controls. Respiratory health problems, nonspecific symptoms, and several ill-defined conditions were also significantly more often reported for Norplant users, but some of the excess incidence may be attributable to reporting and detection bias. The study confirms the safety with respect to serious disease of Norplant, IUDs, and sterilization.
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PMID:Post-marketing surveillance of Norplant((R)) contraceptive implants: II. Non-reproductive health(1). 1137 47

(1) Mirena degrees is a contraceptive intrauterine device delivering levonorgestrel. (2) Its assessment is based on two prospective randomised multicenter trials comparing it to a copper device. (3) It is not known whether it is any more difficult to insert than other devices. (4) Efficacy, in terms of absolute protection and risk of extrauterine pregnancy, appears to be very good, at least equal to that of copper devices. (5) Women were less subject to menorrhagia than were women using a copper device. (6) In clinical trials up to a third of women had amenorrhoea. Some women had spotting during the first three months, and other adverse effects (e.g. acne, headache and mastodynia) were more frequent than among women using copper devices.
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PMID:Levonorgestrel intrauterine device: new preparation. An alternative. 1150 15

A prospective cohort study of Norplant use in the immediate postpartum period among asymptomatic HIV-1-positive women was conducted in Bangkok, Thailand. The objectives of this study were to evaluate side effects and menstrual patterns of the Norplant system in this group. A total of 88 asymptomatic HIV-1-positive mothers were recruited for this study. All of them voluntarily accepted the use of the Norplant implant as a contraceptive method immediately postpartum. Their mean age was 24.9 years. Most of them had completed primary school. The follow-up period was 24 weeks. There were eight participants lost from the study because of loss of contact. Irregular bleeding was the most common menstrual pattern in these participants. The major side effects were headache, followed by hair loss. No subject terminated Norplant use during the study period. The Norplant implant appears to be safe and well tolerated in asymptomatic HIV-1-positive parturients when inserted immediately postpartum.
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PMID:Use of Norplant implants in the immediate postpartum period among asymptomatic HIV-1-positive mothers. 1153 12

Progestogen-only contraceptive implants are highly effective. In most studies, 5-year cumulative pregnancy rates are less than 1.5/100 women for Norplant and Norplant II. No study has yet reported any failures with Implanon. Weight over 70 kg and age at insertion under 25 years both increase the failure rate of Norplant and Norplant II; however, data are as yet lacking for Implanon. The effectiveness of other progestogen-only implants for which there are as yet few data are unlikely to be any different. Continuation rates are high compared with other hormonal methods and with the intrauterine device. In most cohorts at least 35% of women, and often many more, are still using Norplant by the end of 5 years. Rates vary according to a number of factors, including population studied, age, and parity. Menstrual disturbance is by far the most common reason for discontinuation, with headache, acne, weight gain, and desire for pregnancy accounting for other common reasons for implant removal. Fertility returns rapidly following implant removal, and pregnancy rates (76-100% 1 year after removal) are usually no different from those following discontinuation of any other contraceptive method. There is no increase in the risk of ectopic pregnancy, fetal malformation, or impaired infant health in pregnancies conceived either during implant use or after removal.
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PMID:Implantable contraceptives for women: effectiveness, discontinuation rates, return of fertility, and outcome of pregnancies. 1186 Oct 53

The Norplant system is a long-acting hormonal contraceptive method for women which offers high efficacy. The active principal is levonorgestrel, a progestin widely used in oral contraceptives. The Norplant system is in use in various countries including the US, the Dominican Republic, Colombia, Brazil, Chile, Sweden, and Denmark. Norplant consists of silastic capsules containing levonorgestrel which are inserted subdermally in the arm. The progestin is released in constant form from the moment of implantation. 50 mcg are released daily during the first year and approximately 30 mcg are released in subsequent years. Norplant is effective for at least 5 years if a set of 6 capsules is used. Norplant II, consisting of 2 capsules used for 3 years, has come into use more recently. The cumulative pregnancy rate after 5 years of use by 992 women was 2.7/100 continuous users. The annual pregnancy rate was generally less than .5%. No other reversible method has demonstrated the same level of effectiveness during such prolonged periods of use. The mechanism of action is based on inhibition of ovulation in about 50% of cycles, thickening of cervical mucus, and endometrial suppression. Norplant users may present some adverse effects such as menstrual irregularities, amenorrhea, nausea, dizziness, or headaches, but these symptoms are less frequent than with other hormonal methods. Menstrual irregularity is the most frequent secondary effect and the principal cause of termination of use. The secondary effects are generally acceptable. Follow-up during the period of effectiveness of the implants is simple and infrequent. Norplant is an excellent contraceptive choice for women who do not desire pregnancy but do not wish to use a definitive contraceptive method. Once the implant is removed, fertility rapidly is restored.
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PMID:[Norplant: a new alternative in family planning]. 1217 15

Progestin only birth control pills appeared on the US market in 1973. As there is no estrogen in these mini pills, they may have fewer dangerous side effects than the combined pills. Some clinics suggest mini pills for women who suffer from estrogen excess side effects. The 3 mini pills available in the U.S. are called Micronor, NOR-QD, and Ovrette. Instructions are presented for patients who are interested in using mini pills. The mini pills most likely work by affecting a women's fertility in several ways: act as a messenger to the woman's ovaries and uterus to prevent the release of an egg; thicken the mucous on the cervix, making it difficult for the sperm to "get through" the cervix and reach the egg; and change the lining of the uterus so that it may not develop properly for the fertilized egg to grow. The mini pills can be 97% effective is used perfectly. The mini pills are only effective for as long as a woman takes them. A woman must take a pill every day to prevent pregnancy. A woman should not use the mini pill if she has or ever has had any of these problems: blood clotting problems in veins; stroke; cancer of the breast or reproductive parts of the body; suspected pregnancy, current pregnancy; and undiagnosed, abnormal genital bleeding. Possible benefits for a woman using mini pills include: an effective method of birth control; a method for nursing mothers since it does not seem to affect the amount of their breast milk; and a possible reduction in premenstrual cramps. Possible risks for a woman using mini pills include: irregular periods; and a less effective method if the patient does not take a pill every day. The danger signals to look for are abdominal pain, chest pain, headaches, eye problems, and severe leg pain. A patient should revisit a clinic in the following situations: has not had a period within 45 days of the last period; severe abdominal pains while taking mini pills; experiences a warning signal; any time one thinks the pills are causing trouble; and once a year for a pap smear, breast examination, and laboratory tests.
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PMID:How to use mini-pills: helpful patient instructions. 1226 79

A study of 2 low-dose oral contraceptives, Loestrin and Nordette, was conducted in association with the National Family Planning Board in Kota Bharu, Kelantan, West Malaysia, to determine differences in continuation rates and reasons for discontinuation. This report includes analysis of 96 women, 91.7% of whom were interval patients, randomly allocated to 1 of the above OCs between December 1979 and January 1981. Follow-up visits were scheduled at 1, 3 and 6 months after admission with symptom grids completed during the 1st, 3rd, and 6th cycles. The continuation rates at 6 months were 85.9 and 89.8 for Loestrin and Nordette, respectively. The corresponding follow-up rates were 73.9 and 68.3. The side effect reported most often among both groups was breakthrough bleeding (BTB). In addition, the proportion of Loestrin users who reported BTB at least once during the study was significantly higher than the proportion of Nordette users (38.3% versus 18.4%, p 0.05). Other symptoms reported were nausea, headaches, intestinal problems, and abdominal pain. No accidental pregancies were reported during this study. There were a total of 6 (11.8%) discontinuations in the Loestrin group and 4 (8.9%) in the Nordette group.
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PMID:A comparative study of Loestrin versus Nordette in Kelantan, West Malaysia. 1226 18

Results of a large multicentered clinical trial of a new contraceptive vaginal ring show that the new ring may be about as effective as oral contraceptives but with fewer side effects. The ring, which is a little smaller than a 75 mm diaphragm and has a Silastic inner core and outer tubing, is avilable in 2 sizes (50 mm or 58 mm) and contains a middle layer with a steroid mixture of estrogen and progestin. Both types of ring contain about 100 mg levonorgestrel and 50 mg estradiol. Ovulation is suppressed by the steroids in the ring. The ring is placed in the vagina for about 3 weeks and then removed for 1 week. Withdrawal bleeding occurs when the ring is removed. Comparative studies of the effectiveness of the ring and a pill (Nordette, which contains 150 mcg levonorgestrel and 30 mcg estradiol) show that after a year's use, both type of contraceptives had a pregnancy rate of about 3 pregnancies per 100 users. Ring users had higher continuation rates than pill users (50/100 women for the ring vs. 30/100 for the pill). Reasons for discontinuation for the ring include occurrence of vaginal discharge, vaginitis, and menstrual problems. Ring users had lesser incidence of nausea and headache compared to pill users; they also did not experience an increase in angiotensinogen levels or blood pressure. Another advantage of the ring is its once-a-month administration. Investigators are still testing the best method for using the ring. However, as testing is not yet complete, application for approval by the Food and Drug Administration may take quite some time.
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PMID:Trials point to effectiveness of new vaginal ring. 1227 58

The main advantage of the triphasic oral contraceptive (OC) is its reduced corticosteroid content, which is accompanied by a reduction in metabolic impact. Triphasic pills differ according to their components and according to whether or not their estrogen dose is constant. The Triella pill has a constant dose of 35 mcg ethinyl estradiol (EE) and a dose of norethisterone that increases from .50 to 1 mg, while Triquilar-Trinordiol mimics the preovulatory estrogen peak while also varying the progestin content. In a study of 22,728 cycles, the Pearl index was only .06/100 woman years for triphasic pills. Comparisons with existing monophasic pills indicate that triphasics may offer improved cycle control, but the fact should be emphasized to patients that cycle control is an inappropriate criterion for choice of pills. Metabolic effects or possible carcinogenic effects are more important qualities. Triphasic pills have been found to improve acne, not to affect weight or blood pressure, and to reduce the frequency of headaches, nervousness, and breast tenderness. Studies have shown that triphasics containing levonorgestrel produce minimal effects on lipid metabolism, while less rigorous studies on triphasics containing norethisterone have also yielded favorable results. It is true however that knowledge of the relationship between alterations in plasma cholesterol caused by Triella use and the etiology of certain diseases remains incomplete. Low dose triphasic pills appear to have fewer deleterious effects on glucose metabolism than higher dose pills, but they are not entirely without effect and should not be prescribed for women at risk of developing diabetes. Studies examining modifications of the intima and coagulation factors have given reassuring results, and neither triphasics with levonorgestrel nor those with norethisterone modify the blood pressure. Triphasics entail a reduction in the levels of estradiol and testosterone and a slight increase of plasma renin activity but no modification in plasma aldosterone. The subtle effects on the gonodotropic axis are considered especially fitting for young women in whom post-pill ovulatory function is preserved. Endometrial biopsies show that the state of the endometrium with OC use is not well understood and highly variable. The triphasic pill approaches as closely as possible the normal physiology of the endometrium while still suppressing ovulation.
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PMID:[The triphasic pill]. 1228 Feb 9

71 Egyptian women using Norplant contraceptive implants for 1 year were followed with laboratory testing of carbohydrate, lipid and protein metabolism, liver and kidney function tests, serum iron and iron binding capacity and pituitary response to GnRH. The subjects were normal, healthy fertile, non-pregnant, non-lactating women who had not used hormone for 6 months. There were no pregnancies. Most women complained of altered menstrual patterns. Some reported headache, dizziness, increased vaginal discharge, nausea, and pain at the insertion site. There was no significant change in fasting or post-prandial glucose, or kidney function. Cholesterol decreased significantly at 3 months, triglycerides fell at 3 and 12 months, and HDL rose significantly at 3 and 12 months. SGPT fell significantly at 3 and 12 months. Total protein and albumin was significantly lower at 12 months. Serum iron and total iron binding capacity were significantly elevated at 3 and 12 months. Secretion of LH and FSH fluctuated around normal limits. The lipoprotein findings are discrepant from those reported from other developing countries in Norplant trials.
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PMID:Clinical chemistry and pituitary response changes in Egyptian acceptors of L. Norgestrel six rods implants during the first year of use. 1228 53


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