Contact information
Type
Scientific
Contact name
Prof DT Baird
ORCID ID
Contact details
Department of Obstetrics and Gynaecology
Centre for Reproductive Biology
University of Edinburgh
49 Little France Crescent
Old Dalkeith Road
Edinburgh
EH16 4SB
United Kingdom
+44 (0)131 242 6200
dtbaird@ed.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
G9523250
Study information
Scientific title
Acronym
Study hypothesis
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
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
Overall study end date
01/05/1997
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
40 Years
Sex
Female
Target number of participants
40
Participant 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
Recruitment start date
01/03/1996
Recruitment end date
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
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/05/2004 | Yes | No |