Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena Clinical Trial
Official title:
Pre-treatment With Mifepristone in Patients With Mirena for Optimizing Bleeding Pattern in Pre-menopausal Women
Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea and reduce bleeding irrregularities during the initial months of Mirena use.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment