Pretreatment With Mifepristone Prior to Mirena Insertion (MiMi)
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|ClinicalTrials.gov Identifier: NCT01931657|
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : February 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena||Drug: Mifepristone prior to Mirena Drug: Placebo prior to Mirena insertion||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pre-treatment With Mifepristone in Patients With Mirena for Optimizing Bleeding Pattern in Pre-menopausal Women|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Mifepristone prior to Mirena
Pretreatment with mifepristone prior to Mirena insertion
Drug: Mifepristone prior to Mirena
Other Name: Mifepristone
Placebo Comparator: Placebo prior to Mirena
Pretreatment with placebo prior to Mirena insertion
Drug: Placebo prior to Mirena insertion
- Days with bleeding and spotting [ Time Frame: 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)
- Endometrial changes [ Time Frame: 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 [ Time Frame: Evaluated at end of mifeprsitone treatment ]Breast biopsies are obtained at baseline and following 2 months treatment with mifepristone
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931657
|Karolinska University Hospital|
|Stockholm, Sweden, 17176|