Clinical trial · Interventional
Trial of Mifepristone for Fibroids
Randomized Control Trial Of Mifepristone for Fibroids
NCT00133705CI-TRIAL-00069899completedPhase 3Results postedClinicalTrials.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 purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.
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 |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inert Capsule | Drug | — | UNRESOLVED |
| Mifepristone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mifepristone
- description
- Mifepristone 5 MG capsule taken once daily by mouth
- interventionNames
- Drug: Mifepristone
- type
- PLACEBO_COMPARATOR
- label
- Inert capsule
- description
- Placebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth
- interventionNames
- Drug: Inert Capsule
Primary outcomes (1)
- measure
- Uterine Volume
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Gender: Female * Age: 18 - premenopausal * Have at least moderate symptoms of menorrhagia or pelvic pain/pressure * Have a total uterine volume greater than or equal to 160 cc by ultrasound measurement and at least one fibroid that is =\> 2.5cm in size * Have a score of equal to or greater than 39 on the Uterine Fibroid Symptom and Quality of Life scale * Declined standard treatment options for symptomatic fibroids * Agree to use a double-barrier method (condoms, diaphragms) or other effective non-hormonal methods of contraception (abstinence, sterilization) throughout participation in the study to prevent pregnancy and to report any exposure to pregnancy to the research staff immediately * Willing and able to give informed consent * Willing and able to comply with study requirements Exclusion Criteria: * Current or planned pregnancy during the study period * Menopausal, as indicated by follicle stimulating hormone (FSH) level of the reference laboratory * Currently breast-feeding * Untreated abnormal pap smear * Presence of conditions other than fibroids contributing to pain and/or bleeding * Hemoglobin \< 9.0 mg/dl * Presence of adnexal masses or tenderness indicating further evaluation or surgery * Grade III or IV hydronephrosis by ultrasound * Severe, active mental health disorder * Active substance abuse or dependence * Presence of any contraindication to mifepristone including: * Adrenal insufficiency by history * Sickle cell disease * Active liver disease (liver function tests greater than 1.5 times upper range of normal) * Severe, respiratory disease (P02 saturation\< 92%) * Renal disease (serum creatinine \> 1.5 mg/dl) * Blood clotting defect. (abnormal PT and PTT) * Thromboembolic disease (history of deep vein thrombosis or pulmonary embolus) * Current or recent (within the past 3 months) use of the following medications: * Oral or systemic corticosteroids * Hormones: estrogens, progestins, oral contraceptives * Danazol, anticoagulants * Herbal or botanical supplements with possible hormonal effects. * Use within the past six months of the gonadotropin releasing hormones (GnRH) analogs or Depo-Provera. * Current or planned use during the study of any of the following medications/or products: * ketoconazole, * itraconazole, * erythromycin, * grapefruit juice, * rifampin, * St John's Wort, * phenytoin, * phenobarbital, or * carbamazepine
References
Publications (3)
- BACKGROUNDEisinger SH, Bonfiglio T, Fiscella K, Meldrum S, Guzick DS. Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas. J Minim Invasive Gynecol. 2005 May-Jun;12(3):227-33. doi: 10.1016/j.jmig.2005.01.022. PMID 15922980
- BACKGROUNDEisinger SH, Meldrum S, Fiscella K, le Roux HD, Guzick DS. Low-dose mifepristone for uterine leiomyomata. Obstet Gynecol. 2003 Feb;101(2):243-50. doi: 10.1016/s0029-7844(02)02511-5. PMID 12576246
- DERIVEDFiscella K, Eisinger SH, Meldrum S, Feng C, Fisher SG, Guzick DS. Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: a randomized controlled trial. Obstet Gynecol. 2006 Dec;108(6):1381-7. doi: 10.1097/01.AOG.0000243776.23391.7b. PMID 17138770