The effect of a single dose of mifepristone given midcycle on the pattern of menstrual bleeding

Completed

• Conditions: Obstetrics and gynaecology: Menstrual bleeding; Urological and Genital Diseases; Obstetrics and gynaecology

• Registration Number: ISRCTN23968812
• Lead Sponsor: niversity of Edinburgh (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 400

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The length of the menstrual cycle and the pattern of menstrual bleeding.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration