Pretreatment With Mifepristone Prior to Mirena Insertion
- Conditions
- Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena
- Interventions
- Drug: Placebo prior to Mirena insertion
- Registration Number
- NCT01931657
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea and reduce bleeding irrregularities during the initial months of Mirena use.
- Detailed Description
The levonorgestrel releasing intrauterine system (IUS), Mirena, represents a highly effective contraceptive method that is cost-effective and requires limited patient effort. Furthermore Mirena offers numerous noncontraceptive benefits and addresses different medical needs for women in reproductive and non reproductive age. Side effects such as menstrual abnormalities are important reasons for early discontinuation of a contraceptive method. Irregular bleeding pattern and spotting represents a well known adverse effect during the first months of use with Mirena and corresponds to the most important factor that negatively influences the acceptability of the IUS. Up to today no standard treatment has been suggested to resolve this issue.
By inducing amenorrhea within a short period of treatment with an anti-progesterone, mifepristone, prior to insertion of Mirena, the bleeding irregularities during the first months of use might be reduced and could therefore represent an important strategy for increasing acceptability of this contraceptive system.
The purpose of the present study is to evaluate the bleeding pattern during the first months of use of Mirena in patients treated with mifepristone compared to placebo in women using Mirena for contraception. The study will also address the effect of mifepristone on endometrial morphology and breast tissue.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mifepristone prior to Mirena Mifepristone prior to Mirena Pretreatment with mifepristone prior to Mirena insertion Placebo prior to Mirena Placebo prior to Mirena insertion Pretreatment with placebo prior to Mirena insertion
- Primary Outcome Measures
Name Time Method Days with bleeding and spotting During the first 3 months of Mirena use To study the effect of pre-treatment with mifepristone on the initial bleeding pattern in women using LNG-IUS (Mirena)
- Secondary Outcome Measures
Name Time Method Endometrial changes 3 months post Mirena insertion To study the effect of mifepristone pre treatment on the endometrium in women before and during treatment with Mirena with special regard to progesteron receptor modulator associated endometrial changes observed following continuos treatment with mifeprsitone (PAEC).
Effects on breast tissue Evaluated at end of mifeprsitone treatment Breast biopsies are obtained at baseline and following 2 months treatment with mifepristone
Trial Locations
- Locations (1)
Karolinska University Hospital
🇸🇪Stockholm, Sweden