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.
Keywords
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Article info
Publication history
Accepted:
February 12,
2004
Received in revised form:
January 8,
2004
Received:
June 16,
2003
Identification
Copyright
© 2004 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
