Condition category
Pregnancy and Childbirth
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
12/09/2007
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 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

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

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

Phase

Not Specified

Drug names

mifepristone

Primary outcome measures

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 trial start date

01/03/1996

Overall trial end date

01/05/1997

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (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

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=15126582&query_hl=13&itool=pubmed_docsum

Publication citations

  1. Results

    Narvekar N, Cameron S, Critchley HO, Lin S, Cheng L, Baird DT, Low-dose mifepristone inhibits endometrial proliferation and up-regulates androgen receptor., J. Clin. Endocrinol. Metab., 2004, 89, 5, 2491-2497, doi: 10.1210/jc.2003-031945.

Additional files

Editorial Notes