Implanon Nuisance Bleeding Treatment Trial
Research status
Completed
Overview of Study
This was a nine month clinical study looking at the effects of four treatments on prolonged or frequent bleeding in women using Implanon.
The study consisted of 500 participants who:
- were women aged between 18 and 45 years of age
- were using Implanon as a contraceptive for a minimum of three months
- had at least ten months to go before their current Implanon expired
- were experiencing too frequent bleeds - (more than four episodes in three months or bleeding episodes which lasted more than ten days).
Objectives of study
The study consisted of five groups: four treatment groups and a non treatment (placebo) group. The choice of treatment was randomly assigned by a computer. Participants had four out of five chances of receiving active medication and one out of five chances of receiving placebo.
Involvement in the trial lasted nine months and involved three visits to Family Planning NSW.
Participants were given a thorough medical check up including a pap smear and a pregnancy test, and were required to keep a menstrual diary for three months prior to commencement of treatment and three for months after treatment.
Treatments were for five days every 28 days over a three month treatment period.
