Control of menstrual bleeding disturbances in women using Implanon contraceptio
Phase 2
Recruiting
- Conditions
- Breakthrough bleeding with Implanon progestogen-only contraceptionReproductive Health and Childbirth - Contraception
- Registration Number
- ACTRN12605000206628
- Lead Sponsor
- FPA Health, 328 Liverpool Rd Ashfield NSW 2131
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 500
Inclusion Criteria
Implanon users, 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 willing to participate in a research investigation of new approaches to the therapy of breakthrough bleeding.
Exclusion Criteria
Women with contraindications to the use of oestrogen, anti-progesterone or tetracycline therapy; women with allergy to lactose; women who are unwilling to keep a daily menstrual diary or otherwise unwilling to follow the study criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The time taken for an episode of bleeding to cease following initiation of treatment, compared with placebo.[Assessed at the first treatment.]
- Secondary Outcome Measures
Name Time Method There are 6 secondary end points which study the number of days of bleeding and spotting immediately following the initiation of the 5 day course of therapy, compared with the other 3 active therapies.[Comparisons will also be made with the total number of days, episodes and duration of bleeding within the successive 90 day reference period following the initiation of treatment. Comparisons will be made with placebo and with the other 3 active therapies.];All adverse events will be recorded.[]