Problem bleeding with Implanon study
Research status
Completed
Overview of Study
A pilot study has indicated that both mifepristone plus ethynyl oestradiol and doxycycline can stop an episode of menstrual bleeding in women using a progestogen-releasing (etonogestrel) sub dermal implant (Implanon) more effectively than placebo. This main study will compare four treatments, each given at 4 weekly intervals over a period of 90 days, with placebo.
Objectives of study
The aim of this study was to compare three different and promising treatments with a placebo, in women who are using Implanon for contraception and are having either too frequent or prolonged bleeding, or a combination of both.
Participants were:
Implanon users aged 18-45, with a complaint of episodes of prolonged (7 days or greater) or frequent (bleeding free intervals of less than 15 days) bleeding.
Women who are having Implanon replaced provided there has been at least three months since they had their previous Implanon removed and they have not used hormonal treatments during that time.
Women who are willing to participate in a research investigation of new approaches to the therapy of breakthrough bleeding.
Women who are willing to keep a menstrual diary for the duration of the study
- aged between 18 and 45
- have been using Implanon as a contraceptive for a minimum of three month
- experiencing too frequent bleeds, prolonged bleeding or a combination of both.
200 women were enrolled in the study with 50 women assigned to each of the four treatment groups. At the end of the study assessments were made regarding which of the treatments were most effective in controlling bleeding. A larger more detailed investigation of its effectiveness is to be conducted.
Participants were asked to keep a diary of their bleeding pattern for three months before and after treatment. Eligible participants were randomly assigned (toss of a coin) to one of the 3 treatments or placebo, treatment lasted for 5 days.
Visiting the FPA Health clinic on at least 3 occasions over a 6 months period was required.
