Clinical trial · Interventional
Mifepristone to Treat Uterine Fibroids
Treatment of Uterine Myoma With 2.5 or 5 mg Mifepristone Daily During 3 Months With 9 Months Post-treatment Follow-up. Randomized Clinical Trial.
NCT01786226CI-TRIAL-00015547terminatedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral administration of mifepristone 2.5 mg daily for three months | Drug | — | UNRESOLVED |
| Oral administration of mifepristone 5 mg daily for three months | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mifepristone 2.5 mg daily for three months
- description
- Experimental: 1
- interventionNames
- Drug: Oral administration of mifepristone 2.5 mg daily for three months
- type
- EXPERIMENTAL
- label
- Mifepristone 5 mg daily for three months
- description
- Experimental: 2
- interventionNames
- Drug: Oral administration of mifepristone 5 mg daily for three months
Primary outcomes (1)
- measure
- Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTCarbonell JL, Acosta R, Perez Y, Garces R, Sanchez C, Tomasi G. Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial. ISRN Obstet Gynecol. 2013 Jul 29;2013:649030. doi: 10.1155/2013/649030. eCollection 2013. PMID 23984082