title: Effect of intermittent treatment with mifepristone on bleeding patterns in Norplant implant users.
abstract: 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.
authors.affiliation: Consultorio de Planificación Familiar, Instituto Chileno de Medicina Reproductiva, José Victorino Lastarria 29, Depto. 101, Santiago, Chile. rmassai@icmer.org
authors.forename: María Rebeca
authors.initials: MR
authors.lastname: Massai
authors.forename: Margarita
authors.initials: M
authors.lastname: Pavez
authors.forename: Blanca
authors.initials: B
authors.lastname: Fuentealba
authors.forename: Horacio B
authors.initials: HB
authors.lastname: Croxatto
authors.forename: Catherine
authors.initials: C
authors.lastname: d'Arcangues
mesh_terms: 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*
chemical_list: D003271:Contraceptive Agents, Female; D015735:Mifepristone; D016912:Levonorgestrel