Status:
COMPLETED
Mifepristone for Treatment of Uterine Fibroids
Lead Sponsor:
Mediterranea Medica S. L.
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
PHASE3
Brief Summary
The objectives of this study are to estimate the efficacy and safety of the daily administration of mifepristone 5 mg versus 10 mg for three months for the treatment of uterine fibroids. The hypothes...
Detailed Description
Women, in fertile age or in premenopausal status, presenting symptomatic uterine fibroids were randomly assigned to receive 5 mg or 10 of mifepristone. The diminishing of prevalence of symptoms attri...
Eligibility Criteria
Inclusion
- Symptomatic uterine leiomyomata
- Reproductive age or premenopausal
- Accepting the use of non hormonal contraception
- Conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as all side effects of mifepristone
- Agreeing to have ultrasound examinations in every follow-up or evaluation visit
- Agreeing to two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination.
Exclusion
- Pregnancy or desire to become pregnant
- Breastfeeding
- Hormonal contraception or any hormonal therapy received in the last three months
- Signs or symptoms of pelvic inflammatory disease
- Adnexal masses
- Abnormal or unexplained vaginal bleeding
- Suspected or diagnosed malignant neoplastic disease
- Signs or symptoms of mental illness
- Adrenal disease
- Sickle cell anemia
- Hepatic disease
- Renal disease
- Coagulopathy
- Any other severe or important disease
- Any contraindication to receiving antiprogestins
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00712595
Start Date
January 1 2007
End Date
March 1 2009
Last Update
April 23 2009
Active Locations (1)
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1
Hospital Eusebio Hernández
Havana, Ciudad Habana, Cuba, 11400