Obstetrics and gynaecology Pregnancy and Childbirth Obstetrics and gynaecology
Conditions
Interventions
Low dose mifepristone versus placebo.
Follow-up: all participants will attend for screening (on or before day 1 of the control cycle) and then on day 12 of the control cycle for endometrial biopsy and
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 18-40 inclusive 2. Regular menstrual cycles 3. Willing and able to take part in the study 4. Prepared to use barrier contraception for the duration of the study 5. Those who are sterilised or whose partner is sterilised 6. Negative serum alpha HCG test before commencing the study (pregnancy test) 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Those who have used hormonal contraception in the past three months, or depot hormones within six months of entering the trial 2. Those who have breastfed in the past three months 3. Those who have had an IUD in situ in the past three months 4. Long term use of any prescription drugs for a significant medical condition 5. History of cervical surgery which may make endometrial biopsy impossible 6. Pregnancy 7. Vaginal bleeding of unknown aetiology or intermenstrual bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment include menstrual blood loss, urinary oestrogen and progesterone, ultrasound scanning, endometrial evaluation and clinical chemistry and haematology variables. Paired t-tests Wilcoxon signed rank and ANalysis Of VAriance (ANOVA) will be used as appropriate | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed