1ST-YEAR CLINICAL-EXPERIENCE WITH 6 LEVONORGESTREL RODS AS SUBDERMAL CONTRACEPTION

Previous clinical experience with 6 levo-norgestrel subdermal capsules showed a very good contraceptive effectiveness and continuation rate, but with a high proportion of bleeding disturbances, particularly of increased bleeding. Bleeding can evidently be reduced by higher plasma levels of the steroid, using subdermal rods instead of capsules, as rods were shown to have a release rate 3 or 4 times that of the capsules. Volunteers [50] were enrolled in a study of the clinical performance of 6 subdermal levo-norgestrel rods. Results were compared with a previous experience with 100 volunteers who wore 6 levo-norgestrel capsules for a year in the same clinic. Requirement for volunteers to enter the study were the same for capsules and rods. The proportion of women wearing 6 subdermal rods who had increased bleeding was about 1/2 that for the women using 6 levo-norgestrel capsules. Women using rods had about twice the incidence of amenhorrea, and about 4 times more hypomenorrhea (4 days or less of bleeding in a 90 day period). There were no pregnancies among the rod users and the discontinuation rate for medical reasons was not higher than for capsule users in the same clinic.