Status:
COMPLETED
Mifepristone 10 or 5 mg for 6 Months to Treat 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 for 6 months of 5 mg versus 10 mg. A 6 month follow-up of subjects is carried out to estimate how the e...
Detailed Description
Women, in fertile age or premenopausal status, presenting symptomatic myomaswere randomly assigned to receive 5 or 10 mg of mifepristone for six months. The decreasing in the prevalence of symptoms a...
Eligibility Criteria
Inclusion
- Symptomatic uterine fibroids
- 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 the side effects of mifepristone
- Agreeing to have ultrasound examinations in every follow-up or evaluation visit
- Agreeing in 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 :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00886873
Start Date
May 1 2008
End Date
May 1 2009
Last Update
October 17 2014
Active Locations (1)
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1
Hospital Eusebio Hernandez
Ciudad Habana, La Habana, Cuba, 13300