The effect of a single dose of mifepristone given midcycle on the pattern of menstrual bleeding
| ISRCTN | ISRCTN23968812 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23968812 |
| Protocol serial number | G9523250 |
| Sponsor | University of Edinburgh (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 22/05/2003
- Registration date
- 22/05/2003
- Last edited
- 07/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To investigate the effects of a single dose of mifepristone on the length of the menstrual cycle and the pattern of menstrual bleeding. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Obstetrics and gynaecology: Menstrual bleeding |
| Intervention | 10 mg, 25 mg, 200 mg mifepristone or placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Mifepristone |
| Primary outcome measure(s) |
The length of the menstrual cycle and the pattern of menstrual bleeding. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target sample size at registration | 400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2001 |
| Date of final enrolment | 30/09/2003 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Department of Obstetrics and Gynaecology
Edinburgh
EH16 4SB
United Kingdom
EH16 4SB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/10/2006 | Yes | No |
