Uterine Fibroids
Conditions
Keywords
leiomyoma, fibroid, mifepristone, antiprogestins
Brief summary
Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months follow-up period. The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.
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 attributable to uterine fibroids is the most important goal to achieve under both treatments. The possible side effects of mifepristone are slight and women's adherence to treatment is remarkable. Also the reduction of the volumes of the uterus and fibroids contribute to enhance the wellbeing of subjects.
Interventions
DRUGOral administration of mifepristone 2.5 mg daily for three months
Experimental: 1
DRUGOral administration of mifepristone 5 mg daily for three months
Experimental: 2
Sponsors
Mediterranea Medica S. L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment | 3 months | Evaluate efficacy were the percentage changes in fibroid volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of the uterus with 2,5 mg vs 5 md daily of mifepristone after 3 months of treatment. | 3 months | Evaluate efficacy were the percentage changes in uterus volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination |
Countries
Cuba
Outcome results
None listed