New Treatments for Troublesome Bleeding in Implanon Users
Status:
Unknown status
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
Most Implanon users experience a reduction in the frequency and volume of menstrual bleeding,
but a substantial minority experience unpredictable and frequent and/or prolonged episodes of
bleeding. This is a double blind, placebo controlled, randomised study with an additional
randomised non-blinded arm. Two hundred women between the ages of 18-45 years, who are
Implanon users with prolonged or frequent breakthrough bleeding (WHO definition) will be
recruited and randomised into 4 equal-sized treatment groups of 50 women assigned to Marvelon
7 days or 21 days, NuvaRing 21 days or placebo. Recruited subjects will maintain a daily
menstrual diary chart for a minimum of 90 days prior to randomisation, and will be enrolled
into the treatment phase provided that they have met one of the World Health Organization
criteria for prolonged or frequent bleeding Following the initial 90 day record, eligible
women will begin designated treatment on day 1 of the next episode of bleeding or spotting.
Analysis of the subsequent menstrual pattern will begin from day 1 of that bleeding/spotting
episode and will continue through 90 days.