The effect of daily low dose mifepristone on the endometrium - study over four consecutive cycles
| ISRCTN | ISRCTN88271422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88271422 |
| Secondary identifying numbers | G9523250 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 12/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof DT Baird
Scientific
Scientific
Department of Obstetrics and Gynaecology, Centre for Reproductive Biology
University of Edinburgh
49 Little France Crescent
Old Dalkeith Road
Edinburgh
EH16 4SB
United Kingdom
| Phone | +44 (0)131 242 6200 |
|---|---|
| dtbaird@ed.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To assess the effect of daily low dose mifepristone (2 mg or 5 mg) on the ovarian cycle, menstrual bleeding patterns, ovarian follicular growth and the endometrium over a four month period |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Obstetrics and gynaecology |
| Intervention | 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 ultrasound scan. They will attend for study visits following 30, 60, 90 and 120 days of treatment, and also 30 days post-treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | mifepristone |
| Primary outcome measure | 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 outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/1996 |
| Completion date | 01/05/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/1996 |
| Date of final enrolment | 01/05/1997 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Department of Obstetrics and Gynaecology, Centre for Reproductive Biology
Edinburgh
EH16 4SB
United Kingdom
EH16 4SB
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/05/2004 | Yes | No |
