Condition category
Urological and Genital Diseases
Date applied
22/05/2003
Date assigned
22/05/2003
Last edited
07/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.ed.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17027354

Publication citations

  1. 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.

Additional files

Editorial Notes