Clinical trial · Interventional
Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
A Phase III, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
NCT00737282CI-TRIAL-00015435terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Repros stopped study for safety and FDA put study on hold.
Summary
Brief summary (as posted)
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
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 |
|---|---|---|---|
| Proellex 25 mg | Drug | — | UNRESOLVED |
| Proellex 50 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 25 mg Proellex
- description
- Proellex 25 mg once daily
- interventionNames
- Drug: Proellex 25 mg
- type
- ACTIVE_COMPARATOR
- label
- Proellex 50 mg
- description
- Proellex 50 mg once daily
- interventionNames
- Drug: Proellex 50 mg
Primary outcomes (1)
- measure
- To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 48 Years
Show eligibility criteria text
Inclusion Criteria: * Speak, read and understand English or Spanish; * Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study; * One uterine fibroid must be identifiable and measurable by transvaginal ultrasound; * Menstrual cycle lasting from 24 to 36 days; * History of excessive menstrual bleeding; * Negative urine pregnancy test at screening. Additional inclusion criteria may apply. Exclusion Criteria: * Six months or more (immediately prior to Screening Visit) without a menstrual period; * Prior hysterectomy; * Prior bilateral oophorectomy; * Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study; * Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease; * Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV); * Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system; * Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies. Additional exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.