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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

Records of 908 patients of 10 Parisian gynecologists are included in these preliminary results of an ongoing 3-year survey of patient characteristics and consequences of contraception in France. The population averaged 26.8 years, parity 1.1; 39% were single, 21% not working, 15% students, the rest working. These characteristics, and the methods chosen, differed widely among patients of different physicians. 55.5% first chose pills, 26% IUDs, 18.5% chose diaphragm; of these, 28 pill patients, 11 IUD patients and 13 diaphragm patients then chose another method. The second choices were pills by 17, IUDs by 15, and diaphragms by 20. Those who chose pills tended to be single, working, nulliparas, and without previous contraceptive history. IUD and diaphragm users were similar in these characteristics. 7 types of IUDs (61% Corolle, 25% Saf-T-Coil, 16% Omega, 11% Trefle, 10% Sterilem, 6% Lippes loop, 1% Canel) resulted in 23 (9.7%) patients with bleeding side effects and 17 (7.1%) expulsions. 75% of pill patients took Stediril, 25% took 12 other types. Chief complications were weight gain in 11 (1%), nervousness or depression in 11, bleeding in 7, and nausea in 7. There were 7 accidental pregnancies, 2 with IUDs in place, 1 after expulsion (3.5% Pearl index), 4 pregnancies with diaphragm (11.06% Pearl index), and 2 unplanned pregnancies after the women stopped their pill and diaphragm because of their partner's objections.
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PMID:[Follow-up survey of women under contraception]. 1225 83

Studies by A. Albert Yuzpe, MD, and Lee H. Schilling, MD, have shown Ovral to be an effective contraceptive after unprotected intercourse at any time in the menstrual cycle, not just in midcycle. As a morning after pill, Ovral is taken in 2 doses: 2 tablets within 72 hours after coitus; 2 tablets 12 hours later, a total of 200 mcg ethinyl estradiol and 2 mg di-norgestrel. Risk of pregnancy from a single act of unprotected midcycle coitus averages 20-30% while the risk from unprotected intercourse at other times in the cycle averages 2-4%. Young, nulliparoous, women would be the prime target for the morning after pill. 98.5% of the women in Yuzpe's study bled within 21 days. The 1.5% who do not bleed within the expected time will either be pregnant or have a delayed period. Ovral can be administered from a pack in the doctor's office. The major complaint about DES was nausea and vomiting. Only 24% of the women taking Ovral reported nausea. The episodes were mild and controlled with an antiemetic. Both doctors and patients are wary of DES because of public concern about teratogenesis. Many doctors recommend termination of pregnancy if it was conceived while the woman was using DES. Ovral use does not usually indicate abortion. The postcoital IUD insertion studies have included small numbers of patients, but the difficulties are that bleeding following insertion may suggest pregnancy, and the potential for pelvic infection is increased. Ovral should not be given to women who have contraindications to oral contraceptives, and benefits and risks should be weighed.
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PMID:Ovral touted as morning-after pill. 1226 90

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 3 triphasic oral contraceptives currently marketed in the US are describes in reference to steroid composition and manufacturers claims concerning the reduced side affects associated with the triphasics. These triphasics are 1)Ortho-Novum 7-7-7, producted by the Ortho Pharmaceutical Corporation; 2) Tri-Norinyl, produces by Syntex; and 3)Triphasil, produced by Wyeth Laboratries. The 1st 2 formulations were approved by the Food and Drug Administration (fda) in early 1984, andd Triphasil was approved in December, 1984. Despite the recency of triphasic availability, a survey of 13 family planning clinicians, conducted by Contraceptive Technology Update, revealrd that triphasics were the 2nd most common type of OC prescribed by the clinicians. All 3 triphasics provide varying daily doses of progestogen throughout the cycle but only Triphasil varies the daily dose of estrogen. Triphasil provides a total progestogen dose of 1.925 mg of levonor estrel for the entire cycle, and a daily dose of 0.05 mg for 6 days, 0.075 mg for 5 days, and 0.125 mg for 10 days. The total dose of ethinyl estradiol provides by Triphasil is 700 mcg, and the daily dose is 30 mcg for 6 days, 40 mcg for 5 days, and mcg for 10 days. Tri-Norinyl provides a total progedtogen dose of 15.0 mg ofnorethindine at a daily dose of 0.5 mg for 7 days, 1.0 mg for & days, anf 0.5 mg for 5 days. The total ethinyl estradiol dose is 735 mcg provided at a constant rate of 35 mcg for 21 days. Ortho-Novum 7-7-7 provides a total progestogen dose of 15.75 mg of norethindrone at a rate of 0.5 mg for 7 days, 0.75 mg for 7 days, and 1.0 mg for 7 days. The total dose of ethinyl estradiol is 735 mcg provided at a constant rate of 35 mcg/day for 21 days. The triphasics provide low steriod dosages in order to minimize longterm adverse effects; however, unlike other low dose formulations, the triphasics, according to the manufacturers, are associated with only minimal breakthrough bleeding problems. Ortho claims women who use Otrho-Novum 7-7-7 have bleeding patterns similar to those associated with Ortho-Novum 1-35 by the end of the 3rd menstrual cycle. Syntex claims that the incidence of breakthrough bleeding, amenorrhea, weight gain, headachess, nausea, and edema among women who use Tri-Norinyl is similar to that observed among women who use Norinyl 1-35. Wyeth reported that among women who took Triphasil for 25 montha, the total incidence of breakthrough bleeding was only 5.7%. The cost of the triphasics is similar to the cost of other low dose OCs, and the reiphasics are reportedly as effective as the higher dose OCs.
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PMID:Three triphasic oral contraceptives now available in U.S. 1227 12

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

In Hungary, an important form of emergency contraception (EC) is the pill containing 0.75 mg levonorgestrel, which is marketed by Gedeon Richter under the name Postinor in four-pill packages. Women are instructed to take one pill within an hour of any unprotected act of intercourse, up to four pills per month. The nature of the administration requires that women be in possession of the pills before they need them, and, while Postinor is marketed as an EC, the target market is young, unmarried women who experience infrequent intercourse. When it was first offered a decade ago, Postinor gained widespread use in place of contraception. The product was overused and there was a backlash in the medical community. Thus, the manufacturer changed its packaging instructions and removed the original 10-pill package from the market. While the price of the drug is considered prohibitive for use by adolescents, more than three million pills were sold in the past three years in Hungary and more than 60 million pills were sold in over 20 countries. Clinical studies show a failure rate of less than 1% and relatively few side effects (10-20% nausea and 20-40% bleeding) if not more than four pills per month are used. The World Health Organization is currently conducting trials to compare use of Postinor with the Yuzpe method. Results of these trials will be available in 1996.
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PMID:Postinor -- the unique method of emergency contraception developed in Hungary. 1229 Jul 99

A 6-month prospective study of 120 clients of the Bulgarian Family Planning Association was undertaken to document the use, effectiveness, and side effects of the postcoital contraceptive Postinor. 40 of the women used Postinor during 6 cycles, 31 during 5 cycles, 29 during 4 cycles, and 20 during 3 or fewer cycles (total of 570 cycles). Most took 1 tablet within an hour of each intercourse (they were instructed not to use the method more than 4 times per month), but some took 2-4 tablets simultaneously. This misuse resulted in badly tolerated side effects. Side effects occurred in 50% of the clients and included bleeding, delayed menstruation, nausea, headaches, breast tenderness, severe menstrual bleeding, irritability, and weight gain. Four of the subjects became pregnant (these women took the pill a day or more after intercourse). The side effects occurred more frequently in the women who took the most tablets during a month. It was concluded that Postinor should be reserved for emergency use and that clients must be properly counseled about its use and side effects.
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PMID:Prospective study of contraception with levonorgestrel. 1229 Aug

The acceptability and effectiveness of a progestogen-only oral contraceptive (OC), Ovrette, during lactation were investigated in 200 women recruited from a teaching hospital in Khartoum, Sudan. Ovrette contained 0.075 mg of norgestrel. 69 women (34.5%) had used OCs at some point prior to the index pregnancy. Serious complications (e.g., severe headache, chest pain, leg pain, abdominal pain, blurred vision) were reported by 8 respondents during the 12-month study period. Less serious side effects included dysmenorrhea (49 women), nausea (28 women), dizziness (38 women), vaginal discharge (86 women), headaches (78 women), and breast discomfort (21 women). Overall, 143 women (71.5%) experienced at least 1 side effect. Of the 21 women (10.5%) who discontinued Ovrette use before 12 months, 9 were motivated by menstrual problems and other side effects. The 12-month continuation rate was 89.1%. There were 2 pregnancies, only 1 of which represented method failure. These findings are consistent with previous studies indicating that use of progestin contraceptive agents is associated with more menstrual disturbances and pregnancies than combined OCs. Use of combined OCs is contraindicated during lactation, however.
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PMID:A study of a progestogen only oral contraceptive for lactating women in Khartoum, Sudan. 1229 69


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