Fertility regulation in nursing women: VIII. Progesterone plasma levels and contraceptive efficacy of a progesterone-releasing vaginal ring.
The objectives of this trial were to test the contraceptive efficacy and measure progesterone plasma levels of women using progesterone-releasing rings during lactation. Two types of rings delivering an average of about 5 mg or 10 mg of progesterone per day were tested in 128 healthy nursing women. A control group was formed by 127 Copper T users. Rings were inserted at day 60 postpartum and replaced every 3 months with a new one. Initially progesterone plasma levels were around 10 nmol/l and 15 nmol/l for rings releasing 5 and 10 mg per day, respectively, and decreased slightly after 30 days. Levels observed in subsequent segments of use approximated those of the first segment. These levels are within the range shown to inhibit fertility in lactating women. One pregnancy was diagnosed in 739 woman-months of progesterone ring use, and none occurred in 794 woman-months of Copper T use, which contrasts with the high incidence of pregnancy in a group of untreated nursing women where 19 pregnancies resulted during 677 woman-months. No deleterious effects were detected lactation and infant growth or maternal and infant health. It is concluded that the vaginal rings releasing progesterone are a suitable contraceptive method for lactating women.
D002986:Clinical Trials as Topic; D003270:Contraceptive Agents; D003692:Delayed-Action Preparations; D005260:Female; D005298:Fertility; D006801:Humans; D007435:Intrauterine Devices, Copper; D007774:Lactation / Q000187:drug effects*; D008598:Menstruation / Q000187:drug effects; D011247:Pregnancy; D011374:Progesterone / Q000008:administration & dosage* / Q000097:blood / Q000494:pharmacology; D013997:Time Factors; D014621:Vagina
D003270:Contraceptive Agents; D003692:Delayed-Action Preparations; D011374:Progesterone