Clinical trial · Interventional
Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids
Mifepristone 5 mg Versus 10 mg During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
NCT00886873CI-TRIAL-00015859Mifemyo_2completedPhase 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)
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.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mifepristone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Oral administration of mifepristone 5 mg daily for six months.
- interventionNames
- Drug: Mifepristone
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Oral administration of mifepristone 10 mg daily for six months.
- interventionNames
- Drug: Mifepristone
Primary outcomes (1)
- measure
- Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.