Obstetrics and gynaecology: Menstrual bleeding Urological and Genital Diseases Obstetrics and gynaecology
Conditions
Interventions
10 mg, 25 mg, 200 mg mifepristone or placebo
Sponsors
University of Edinburgh (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female volunteer aged 18-40 years inclusive 2. Prepared to use barrier methods for the duration of the study, already have an Intra-Uterine Device (IUD) in-situ, previously sterilised (subject or partner), or not requiring contraception 3. Regular menstrual cycles of between 25 to 35 days with no greater than three days variation in the past three months 4. Willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Those who have used any type of hormonal contraception within three months of starting the trial 2. Clinically relevant abnormal findings during the physical/gynaecological examination 3. Those who have breastfed in the past three months 4. Current treatment with corticosteroids 5. Treatment with an investigational drug within one month of inclusion 6. Long term use of any prescription drugs for a significant medical condition 7. Chronic alcoholism, drug abuse or any other condition associated with poor patient compliance 8. Undiagnosed vaginal bleeding 9. Other significant disease e.g. cardiovascular, renal or liver disease or malignancy, sufficient to interfere with the evaluation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The length of the menstrual cycle and the pattern of menstrual bleeding. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed