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User compliance is not a problem for the recently approved subdermal, longterm contraceptive delivery system, Norplant. It delivers 50-80 mcg of levonorgestrel/day during the 1st year and 30-35 mcg for years 2-5. The levonorgestrel is encased in 6 36 mm x 2.4 mm capsules which are placed in the upper arm in 5-10 minutes using local anesthesia. Since the implants systemically release levonorgestrel, the shock to the liver experienced in oral contraceptive (OC) users does not occur. Levonorgestrel prevents pregnancy by decreasing luteinizing hormone and follicle stimulating hormone which prevents ovulation, reducing the rate of ovum transfer in the tube, making the endometrium incompatible for implantation, and making the cervical mucus too thick and scanty for sperms to migrate if ovulation does occur. 1-year pregnancy rates for Norplant users are much lower than for women who use other contraceptives (0.6/100 users vs. 2.3/100 for OC users and 2.4/100 for IUD users). The ectopic pregnancy rate is also low (1.47/1000 Norplant users). The 1-year continuation rate is 80% compared with 50% for OC users. Fertility returns within 3 months for 50% of users and within 1 year for 80%. Because Norplant does not adversely affect lipid metabolism there is no increase in the risk of atherogenesis. Menstrual irregularities are the leading side effect of Norplant. The irregular cycles tend to occur during the 1st 3-6 months after insertion. Other side effects include headaches, acne, breast discharge, weight gain, and transient ovarian cysts. Contraindications are abnormal uterine bleeding, possible pregnancy, active liver disease, and women taking phenytoin. The cost for the initial exam and insertion of the Norplant capsules is $500 at Planned parenthood of the Rocky Mountains in Colorado (mean=$8.30/month vs. $13/month for 5 years of taking OCs). Due to the possibility of exploitation of women and involuntary infertility, nurse practitioners must thoroughly explain the system to each patient and answer all questions so the patient can give informed consent.
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PMID:New concepts in contraception: Norplant subdermal implant. 156 6

Between October 1986 and November 1988, physicians enrolled 267 20-41 year old women in a clinical trial of Norplant-2 (2 Silastic rods with 70 mg levonorgestrel each) at the National Taiwan University Hospital to evaluate the advantages and side effects of Norplant-2. 36 women were lost to follow up. 63% suffered from menstrual problems during the first 3 months. 73.6% of these women still had menstrual problems at 6 months. 6 women then chose to discontinue using Norplant-2. 51.8% of the remaining women had persistent menstrual problems at 1 year. 62% of women who discontinued Norplant-2 before the end of 3 years discontinued it due to menstrual problems. The continuation rate was 84.5% at 1 year, 61.3% at 2 years, and 52% at 3 years. 78.6% of women who discontinued Norplant-2 to become pregnant conceived within 1 year after its removal. Just 1 woman (.04%) became pregnant while using Norplant-2. She was thin and smoked heavily. Her aborted fetus had an abnormal fetus had an abnormal karyotype (47,XY,+22). The mean serum total cholesterol and triglyceride levels dropped considerably after Norplant-2 implantation from 164 to 147 mg/dl and from 81 to 63 mg/dl at 12 months, respectively; p .05). Mean hemoglobin levels increased from 12.6 g/dl to 13 g/dl at 12 months (p .05). Levonorgestrel did not affect liver or renal functions. Mean body weight and blood pressure remained the same. Observed psychophysiologic symptoms included depression, acne, headaches, nervousness, and insomnia. These findings indicated Norplant-2 to be safe, reversible, long-acting, and very effective, therefore the family planning program in Taiwan should add it to its contraceptive menu.
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PMID:Norplant-2 subdermal contraceptive system: experience in Taiwan. 810 98

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

Levonorgestrel-releasing implants are long acting contraceptives, approved for 5 years of continuous use. Two marketed systems, the six capsule Norplant use of tradenames is for product identification purposes only and does not imply endorsement. and the two rod Jadelle, have essentially equal rates of drug release, pregnancy and adverse events over 5 years of use. Randomised clinical trials and controlled cohort observations indicate that for the first 3 years, when pregnancy rates are at or almost zero, no other contraceptive system is more effective, although etonogestrel implants provide equal effectiveness. Annual pregnancy rates rise in the fifth year of continuous use but remain below 1 per 100 women. Annual pregnancy rates of Norplant users remain below 1 per 100 throughout 7 years of continuous use. Levonorgestrel implants provide low progestogen doses; 40-50 microg/day at 1 year of use, decreasing to 25-30 microg/day in the fifth year. Serum levels of levonorgestrel at 5 years are 60-65% of those levels measured at 1 month of use. Adverse effects with levonorgestrel implants are similar to those observed with progestogen only and combined oral contraceptives. Risks of ectopic pregnancy, other pregnancy complications and pelvic inflammatory disease are reduced in comparison with those of women using copper or non-medicated intrauterine devices. Risks of developing gallbladder disease and hypertension or borderline hypertension, although small, are about 1.5 and 1.8 times greater, respectively, in women using levonorgestrel implants than in women not using hormonal contraception. Other serious diseases have not been found to occur significantly more frequently in levonorgestrel implant users than in women not using hormonal contraception. The great majority of levonorgestrel implant users experience menstrual problems, but serious bleeding problems are not more frequent than in controls. Other health problems reported more frequently by levonogestrel implant users than by women not using hormonal contraception in a study of 16000 women included skin conditions, headache, upper limb neuropathies, dizziness, nervousness, malaise, minor visual disturbances, respiratory conditions, arthropathies, weight change, anxiety and non-clinical depression. Clinical depression is not more frequent in women using implants compared with those not using hormonal contraception (i.e. using intrauterine devices, sterilisation). Removal problems occur less frequently with Jadelle than with Norplant. The mean removal time for Jadelle is half that of Norplant. Levonorgestrel implants in nationally representative scientific samples, in randomised trials, and in controlled cohort studies have continuation rates as high as or higher than any other reversible contraceptive over a duration of 5 years. This would imply that the satisfaction women derive from the contraceptive effectiveness of levonorgestrel implants greatly outweighs the dissatisfaction that may accompany menstrual disturbances and other adverse effects associated with implants.
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PMID:Risks and benefits, advantages and disadvantages of levonorgestrel-releasing contraceptive implants. 1265 Jun 33

Emergency contraception may avoid pregnancy after unprotected intercourse or when regular contraceptive measures fail. Levonorgestrel, a synthetic gestagen, is recommended for emergency contraception as a single 1.5-mg dose or, alternatively, two 0.75-mg doses taken 12 h apart. Its efficacy is moderate, preventing about 80% of pregnancies. Efficacy is higher the earlier after unprotected intercourse the drug is taken, but it may be administered up to 5 days post-coitum. Tolerance is similar to, or better than, those of other oral emergency contraceptives. Adverse effects include nausea, vomiting, headache, breast tenderness and transient alteration of menstrual bleeding pattern. It is not known whether levonogestrel increases the risk of ectopic pregnancy when the treatment fails. Its use as an ongoing contraceptive method is discouraged. When given before the preovulatory LH peak, levonorgestrel blocks or delays ovulation. It may also affect sperm migration in the female reproductive tract and have an effect on fertilization. Although it has been often postulated, there is no evidence for an anti-implantatory effect. Acquaintance with the method is quite variable among different societies, but it remains underutilized even where it is well known. Advance provision of the drug has been proposed as a way to promote its use. In clinical trials, advance provision did not adversely modify sexual or regular contraceptive behavior, but it did not reduce pregnancy or abortion rate either. Therefore, emergency contraception with levonorgestrel should be regarded as a backup method which is not a substitute for the continued use of more effective contraceptive methods.
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PMID:[Emergency contraception with levonorgestrel]. 1805 Dec 34