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
Secondary identifying numbers G9523250
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

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
Email dtbaird@ed.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeOther
Scientific title
Study objectivesTo 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) studiedObstetrics and gynaecology: Menstrual bleeding
Intervention10 mg, 25 mg, 200 mg mifepristone or placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Mifepristone
Primary outcome measureThe length of the menstrual cycle and the pattern of menstrual bleeding.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/12/2001
Completion date30/09/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
Lower age limit18 Years
Upper age limit40 Years
SexFemale
Target number of participants400
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2001
Date of final enrolment30/09/2003

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Department of Obstetrics and Gynaecology
Edinburgh
EH16 4SB
United Kingdom

Sponsor information

University of Edinburgh (UK)
University/education

Old College
South Bridge
Edinburgh
EH8 9YL
Scotland
United Kingdom

Phone +44 (0)131 650 1000
Email communications.office@ed.ac.uk
Website http://www.ed.ac.uk/
ROR logo "ROR" https://ror.org/01nrxwf90

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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