Contact information
Type
Scientific
Primary contact
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 number
ClinicalTrials.gov number
Protocol/serial number
G9523250
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Other
Patient information sheet
Condition
Obstetrics and gynaecology: Menstrual bleeding
Intervention
10 mg, 25 mg, 200 mg mifepristone or placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Mifepristone
Primary outcome measure
The length of the menstrual cycle and the pattern of menstrual bleeding.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2001
Overall trial end date
30/09/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
400
Participant 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
Recruitment start date
01/12/2001
Recruitment end date
30/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Obstetrics and Gynaecology
Edinburgh
EH16 4SB
United Kingdom
Sponsor information
Organisation
University of Edinburgh (UK)
Sponsor details
Old College
South Bridge
Edinburgh
EH8 9YL
United Kingdom
+44 (0)131 650 1000
communications.office@ed.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17027354
Publication citations
-
Results
Narvekar N, Glasier A, Dada K, Van der Spuy Z, Ho PC, Cheng L, Baird DT, Toward developing a once-a-month pill: a double-blind, randomized, controlled trial of the effect of three single doses of mifepristone given at midcycle on the pattern of menstrual bleeding., Fertil. Steril., 2006, 86, 4, 819-824, doi: 10.1016/j.fertnstert.2006.02.115.