Uterine Fibroids
Conditions
Keywords
Uterine fibroids, Mifepristone, Antiprogestins
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 effects of mifepristone are kept in time. The hypothesis of this study is that both mifepristone doses reduce the volume of the myoma up to 50% in six months treatment.
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 attributable to myomas is an important goal to achieve under both treatments. Another goal is to maintain for more than 6 months the benefits of the treatment with mifepristone.
Interventions
DRUGMifepristone
Sponsors
Mediterranea Medica S. L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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 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 |
|---|---|
| Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone. | 6 months |
Countries
Cuba
Outcome results
None listed