Effect of intermittent treatment with mifepristone on bleeding patterns in Norplant implant users.
A double-blind, placebo-controlled, randomized trial, was carried out in 120 Norplant users to evaluate the effect of mifepristone, 100 mg/day administered for 2 consecutive days every 30 days, on the vaginal bleeding pattern. Treatment was given from months 2-7 of implant use. Volunteers recorded bleeding and spotting days, during treatment and for the ensuing 6-month period. During treatment, women on mifepristone recorded the same frequency of bleeding/spotting episodes but significantly less prolonged bleeding episodes than placebo controls (mean +/- SD: 11 +/- 3 vs. 22 +/- 23 days) and their total number of bleeding days was 35% lower than in the placebo group. After the end of mifepristone use, bleeding patterns were similar in both groups. One pregnancy occurred in the mifepristone-treated group, in month 6 of treatment, the outcome was a healthy male baby. We conclude that intermittent administration of mifepristone can offer a clinically significant improvement of the vaginal bleeding pattern in Norplant users.
Massai
María Rebeca
MR
Consultorio de Planificación Familiar, Instituto Chileno de Medicina Reproductiva, José Victorino Lastarria 29, Depto. 101, Santiago, Chile. rmassai@icmer.org
Pavez
Margarita
M
Fuentealba
Blanca
B
Croxatto
Horacio B
HB
d'Arcangues
Catherine
C
D000284:Administration, Oral; D000328:Adult; D003271:Contraceptive Agents, Female / Q000009:adverse effects*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016912:Levonorgestrel / Q000009:adverse effects*; D015735:Mifepristone / Q000008:administration & dosage / Q000627:therapeutic use*; D011247:Pregnancy; D011446:Prospective Studies; D016896:Treatment Outcome; D014592:Uterine Hemorrhage / Q000139:chemically induced / Q000188:drug therapy*
D003271:Contraceptive Agents, Female; D015735:Mifepristone; D016912:Levonorgestrel