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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

More than 300 subscribers of Contraceptive Technology Update (CTU) completed the questionnaire for the 1994 Pill Survey. Most respondents (68%) were nurse practitioners followed by physicians (11%), registered nurses (9%), and physician assistants (4%). 92% of respondents considered oral contraceptives (OCs) (especially Ortho-Cept and Ortho Novum 7/7/7) as the leading hormonal contraceptive choice among adolescents and adults. Among teens, Depo-Provera was the second choice (4%). Among adults, Depo-Provera and the contraceptive implant, Norplant, fared equally as well (2% each). Headaches, mood swings, and weight gain continued to be complaints for all hormonal contraceptives. Progestins are potent depressants. Norplant produced the most complaints. About 20% of providers reported that at least 20% of their patients wanted Norplant implants removed because of significant side effects, especially irregular bleeding. Most Norplant users had the implants for no more than 12 months. The providers realized that they were providing insufficient counseling to Norplant users about irregular bleeding before insertion. A physician noted that some women experience infertility for as long as two to three years after their last Depo-Provera injection. Some providers discourage women from using Norplant based on the many complaints they have received from past users.
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PMID:Depo-Provera and Norplant implants prove no competition for no. 1 choice, OCs. The 1994 pill survey. 1228 3

Modeled after the naturally occurring hormone progesterone, progestins are the synthetic hormones used in Norplant, depot-medroxyprogesterone acetate (DMPA), and progestin-only pills (POPs). Progestin-only contraceptives alter a woman's hormonal balance. In so doing, progestin-only contraceptives block a series of chemical signals essential to the completion of a normal reproductive cycle, either by blocking the release of an egg or by making its fertilization and implantation within the uterus unlikely. In many women, progestin-only contraceptives stop the monthly release of an egg. Even if an egg is released, progestin makes its movement through the fallopian tubes into the uterus more difficult. Progestin also thickens the mucus in the cervix, which stops sperm from penetrating the mucus and reaching an egg. In the unlikely event that ovulation does occur and an egg becomes fertilized, the hormonal disruption makes the lining of the uterus inhospitable for implantation. This multiple mode of action therefore makes progestin-only methods among the most reliable of all contraceptives. Norplant and progestin-only injectables have failure rates of less than 1%, while POPs are typically 95% effective. Sections discuss ovulatory suppression, physiological changes, weight gain and headaches, health concerns, and counseling before use.
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PMID:Progestin-only methods are very effective. 1228 32

A 1997 Contraceptive Technology Update survey of 145 US family planning practitioners found that oral contraceptives (OCs) remain the leading reversible contraceptive method, chosen by 85% of adult women and 78% of teenagers. Ortho Tri-Cyclen is the first choice among OC brands, presumably because of its recent US Food and Drug Administration endorsement for acne control. Ortho Tri-Cyclen is the first low-dose OC to be indicated for noncontraceptive use. 11% of adult women and 17% of teenagers preferred Depo-Provera in 1997, compared with 6% and 11%, respectively, in 1996. Another study, commissioned by the US Association of Reproductive Health Professionals, indicated 85% of current OC users are very satisfied with the method and 50% of former users still prefer it over other forms of birth control; 75% would advise a young woman to use OCs. Although weight gain, severe headaches, and mood swings may affect users of OCs, Depo-Provera, and Norplant, OC users are less likely to discontinue method use because of these side effects than users of implants and injectables.
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PMID:Oral contraceptives hold top position as leading choice for women. 1229 67

This article is about the decision made by Wyeth-Ayerst to settle lawsuit claims filed by more than 36,000 American women concerning the use of the Norplant contraceptive implant system. The settlement, estimated at $50 million, would end 5 years of litigation involving Norplant. The plaintiff's lawyers claimed that the company downplayed such side effects as irregular menstrual bleeding, nausea, headaches, and depression. Wyeth-Ayerst Laboratories and parent company American Home Products Corp. have denied any wrongdoing and claimed that the side effects were described in the product label. The agreement to settle the Norplant claims were described as purely a business decision by Wyeth-Ayerst North America president Joseph Mahady.
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PMID:Manufacturer moves to settle Norplant claims. 1229 28

A clinical trial was carried out on the levonorgestrel-containing subdermal contraceptive implant to evaluate its efficacy and acceptability among Malaysian women. The study recruited 121 women in and around the Kuala Lumpur Federal Territory over a 13-month period (March 1986-March 19870 and followed regularly for 2 years at intervals of 3, 6, 12, and 24 months. The acceptors consisted of 53.7% Malays, 24.8% Indians, and 21.5% Chinese. 81% of the selected females were between 20-34 years in age (mean=30). The average parity was 3.9 children; 81.8% reported that they did not want to have a child in the he next 3 years. In the last 6 months, 45.5% of the study group had used the oral contraceptive pills, 15.7% had used the intrauterine contraceptive device, and 17.4% had not employed any method. The results showed that the subdermal implant Norplant (R) is effective and safe. The gross cumulative continuation rate was 93.8 at 6 months, 88.2 at 12 months, and 72.2 at 24 months. Within the 24 month period, 26 terminations occurred as a result of pregnancy (n=1), menstrual problems (n=9), medical reasons (n=12), and personal reasons (n=4). the gross cumulative termination rate/100 women for pregnancy was 0 at 12 months and 1.7 at 24 months. Major side effects include menstrual problems, weight gain, dizziness, and headache. After 1 year, 13.3% of the cases (n=2) had the implant removed. The acceptability of the method among our women in 4 clinics around Kuala Lumpur and other Norplant (R) studies in other countries is comparable to the intrauterine devices among Malaysian women; the termination rate for accidental pregnancy is lower than that of IUD. The device is easy to administer in a small clinical set-up though it requires personnel specially trained in the surgical techniques; 86.0% of the acceptors reported complication-free insertion. This may be a method to be introduced to our National Family Planning Program in our efforts to offer a wider range of safe and effective methods of family planning. (author's modified).
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PMID:A study of the acceptability and effectiveness of Norplant (R) contraceptive implants in Kuala Lumpur, Malaysia. 1231 41

35 predominantly multiparous, sexually active women aged 25-44 years were fitted with levonorgestrel 20 T (Schering) IUDS in the post- menstrual phase, or in rare instances, right after abortion. the devices contained 60 mg of levonorgestrel releasing 20 mcg/day with the life span of 5 years. The patients were followed up every 3-6 months to detect side effects and complications. The first year contained a total of 339 months of observation, while the figure rose to 461 months in the second year. Spotting lasting 15-20 days followed insertion, but in later months only 7% of patients complained of bleeding or menstrual spotting. 7-8% of cases tended to have oligomenorrhea in the first year; 1/3 to 1/2 of them had hypomenorrhea during the first and second year. True amenorrhea started in 20-30% of women, persisting through both years. Longer duration of flow occurred in 32.4-4.57.1% of cases during these 2 years. Hormonal effects (headache, acne, hirsutism, depression, mastalgia, and inflamed varicose veins) ranged from 18.2- 33.3%. Levonorgestrel 20 T demonstrated more superior contraceptive efficacy than Progestasert; however, serious menstrual cycle disorders associated with it also increased. All progestin-releasing devices (the minipill, Norplant, Progestasert) induced menstrual changes, thus their use is preferable for therapeutic indications such as hypermenorrhea and uterine fibroid.
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PMID:[Two-year clinical performance of the Levonorgestrel 20 T IUD]. 1231 72

The Norplant System of levonorgestrel implants and the Depo Provera contraceptive Injection of sterile medroxy progesterone acetate suspension (DMPA) are longterm, progestagen-based contraceptive delivery systems designed to overcome noncompliance which are under review for use in Canada. 150 mg of DMPA, a pregnane compound derived from progesterone, is injected every 3 months. Peak plasma concentrations are reached in 24 hours and plateau for 3-4 months before gradually declining. After termination, ovulation returns on average in 4.5 months, and conception occurs at a median time of 10 months. 90% conceive by 24 months. In the Norplant system, a steady daily supply of 50-80 mcg of levonorgestrel, a gonane progestin derived from the testosterone nucleus which has both progestogenic and androgenic receptor affinity, diffuses from 5 Silastic implants, which must be replaced every 5 years. Ovulation and fertility return rapidly after rod removal. The actual and lowest expected failure rates are equal for both systems. The failure rate for DMPA is .3 pregnancies per 100 women years, while that for levonorgestrel is .4% in 1 year. Although neither method affects blood pressure, DMPA appears to affect carbohydrate metabolism by impairing glucose tolerance and increasing insulin production. Lipid metabolism is also affected. 5% of those who use levonorgestrel discontinue it because of side effects, including headache, mastodynia, and acne; 19.1% of DMPA users did so, especially for weight gain and menstrual cycle abnormalities. Both methods have a higher frequency of menstrual abnormalities than normal. 27.7% of levonorgestrel users experienced prolonged bleeding, while 17% experienced spotting during the first 6 months. However, normal menses usually returned within a year, and only 7.9% discontinued use because of cycle abnormalities. In 1 study, less than 10% of DMPA users experienced normal cycles, and in another study 35% experienced amenorrhea (500/700 discontinued use). Amenorrhea replaced irregular bleeding with continued use, occurring in 68% of users by 2 years. There is also some concern about DMPA and breast cancer and bone loss. Based on 1 case-control study of 110 women with breast cancer who had taken DMPA, the relative risk is highest for those between ages 25 and 34 who use DMPA longer than 6 years. A WHO study concluded that the relative risk of developing breast cancer, because of DMPA, is inversely related to duration of use. A Phase IV study on DMPA and bone mineral density has been undertaken.
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PMID:A comparison of levonorgestrel implants with depo-medroxyprogesterone acetate injections for contraception. 1231 30

Results are presented of a clinical study of Norplant subdermal implants in Colombian adolescents. Implants have been used by 365 adolescents, of whom 174 have completed 2 years of follow-up. Study participants were monitored at months 1, 3, 6, 12, 18, and 24 postinsertion. Among the 174 women, 14% were 14-17 years old and 87% were 17-19. 21% were single, 30% married, and 49% in consensual unions. 38.5% were nulliparous, 56% had 1 child, and 5.7% had 2. 14.3% had a history of abortion. There were no pregnancies in the 2 years. 47.9% of users experienced menstrual irregularities at least once during the 2 years, with 9.3% reporting spotting or staining, 21.2% bleeding, and 19.3% amenorrhea. 6.4% reported nausea, 4.3% headache, 4.3% weight alterations, 2% acne, and 1.4% hair loss. There were 12 removals in the 2 years, 3 each because of menstrual and weight alterations, 2 for headaches, and 4 because of desire for pregnancy. 91.4% declared themselves satisfied with the method. The continuation rate was 93.2% at 2 years. The results suggest that Norplant is a good contraceptive choice for adolescents, but a prolonged study over 5 years is needed to confirm the findings.
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PMID:[Norplant: an effective option for adolescent women. Subdermal implant contraception in adolescent women. Preliminary findings in 174 cases]. 1231 5

The 832 women who accepted Norplant implants at three hospitals in Peru between December 1988 and February 1991 participated in a study of Norplant method acceptability and user characteristics. The women were seen 1, 3, and 6 months after insertion and every 6 months thereafter. They ranged in age from 18 to 40 years and averaged 28. Nearly 78% had completed secondary school or had higher education. The average number of children was 2.1, and 87% had 3 or fewer children. 30.1% of the women had had 1 abortion, 13.0% had had 2, 2.2% had had 3, and 1.1% had had 4 or more. 47.3% of the women had previously used oral contraceptives or IUDs, 13.1% had used rhythm, 11.2% had used condoms or vaginal methods, 4.9% had used injectables, 1.6% had used other methods, and 21.9% had used no method. 47.9% stated they wanted no future pregnancies, 37.4% wanted to wait at least 3 years, and 6.3% were uncertain. Menstrual problems were the major side effect reported. 22 of the 71 removals were motivated by headaches, 18 by menstrual problems and 13 by medical problems. The continuation rate at 12 months was 88.75%. No pregnancies occurred.
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PMID:[Characteristics of Norplant users in Lima, Peru]. 1232 14


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