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ISRCTN
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ISRCTN88271422
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DOI
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10.1186/ISRCTN88271422
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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The effect of daily low dose mifepristone on the endometrium - study over four consecutive cycles
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Scientific title
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Acronym
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N/A
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Serial number at source
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G9523250
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Obstetrics and gynaecology
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/03/1996
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Anticipated end date
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01/05/1997
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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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
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Contact name
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Prof
DT
Baird
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Address
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Department of Obstetrics and Gynaecology, Centre for Reproductive Biology
University of Edinburgh
49 Little France Crescent
Old Dalkeith Road
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City/town
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Edinburgh
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Zip/Postcode
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EH16 4SB
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Country
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United Kingdom
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Tel
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+44 (0)131 242 6200
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Fax
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+44 (0)131 242 2695
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Email
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dtbaird@ed.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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12/09/2007
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Date ISRCTN assigned
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25/10/2000
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