Pre-treatment with Mifepristone prior to Mirena insertion for optimizing bleeding pattern in pre-menopausal women - mifepristone prior to Mirena
- Conditions
- The main objective of the present study is to study the effect of pre-treatment with Mifegyne in pre-menopausal women requesting Mirena for contraception in order to imrpove bleeding pattern during the initial months of Mirena treatment.
- Registration Number
- EUCTR2009-009014-40-SE
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
•Pre-menopausal women, >/= 18 years of age.
•Desire of Mirena for contraception
•Good general health
•Willing and able to participate after giving informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
•Any hormonal treatment or IUD use within 2 months prior to study start
•History of malignant disorder of the breast
•Any contraindication to mifepristone
•Pregnancy or breast feeding within 2 months prior to study start
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method