A three-year clinical trial with levonorgestrel silastic implants.
Silastic implants containing the progestin, levonorgestrel, were tested as long-term contraceptives in 101 women. After three full years of exposure and 2,998 woman-months of use, no pregnancies had occurred. The continuation rates were 87% at 12 months, 79% at 24 months and 66% at 36 months. The most important side effect was excessive or irregular bleeding during the first year. No treatment was offered for this side effect other than vitamins and iron or change of method, with the exception of 3 cases where ethinyl estradiol was used one time for 2 weeks each. Bleeding disturbances led 8 patients to ask for removal of implants. Other side effects were headache, acne and lower abdominal pain. Blood and urine analysis tested 17 different parameters and all but plasma cortisol remained within normal limits throughout the study. A general tendency toward lowered cortisol values was observed and two subjects had more than one value below the normal limit for the population during the study. Glucose tolerance tests during the second year were abnormal in two women with familial diabetes but they returned to normal values spontaneously at the next test. It is concluded that levonorgestrel implants offer effective protection against pregnancy during the first three years of continuous use. Their acceptability and few side effects justify larger trials, especially if treatment of bleeding irregularities is introduced.
D000005:Abdomen; D000328:Adult; D001774:Blood Chemical Analysis; D002986:Clinical Trials as Topic; D004343:Drug Implants; D005260:Female; D005298:Fertility / Q000187:drug effects*; D006261:Headache / Q000139:chemically induced; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008598:Menstruation / Q000187:drug effects; D009644:Norgestrel / Q000009:adverse effects / Q000494:pharmacology*; D010146:Pain / Q000139:chemically induced; D011247:Pregnancy; D012826:Silicone Elastomers
D004343:Drug Implants; D012826:Silicone Elastomers; D009644:Norgestrel; D006854:Hydrocortisone