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.
Conditions
Interventions
Trade Name: Mifegyne
Product Name: Mifegyne
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the present study is to study in pre-menopausal women requesting Mirena for contraception: 1. the effect of pre-treatment with mifepristone on the bleeding pattern in women using the Mirena contraceptive system ;Secondary Objective: 2.To study the effect of mifepristone pre treatment on the endometrium in women before and during treatment with Mirena. 3.To further study the effect of mifepristone on breast tissue in premenopausal women.;Primary end point(s): Bleeding pattern during the first three months following insertion of Mirena | — |
Countries
Sweden
Outcome results
None listed