Clinical trial · Interventional
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
NCT00882258CI-TRIAL-00015025completedPhase 2ClinicalTrials.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)
Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 12.5 mg Proellex | Drug | — | UNRESOLVED |
| 25 mg Proellex | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 12.5 mg Proellex
- description
- Proellex 12.5 mg daily
- interventionNames
- Drug: 12.5 mg Proellex
- type
- EXPERIMENTAL
- label
- 25 mg Proellex daily
- description
- Proellex 25 mg
- interventionNames
- Drug: 25 mg Proellex
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo daily
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound. * Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain Exclusion Criteria: * Post-menopausal women, as defined as one or more of the following: 1. six months or more (immediately prior to Screening visit) without a menstrual period, or 2. prior hysterectomy and/or oophorectomy * Subjects with documented endometriosis
References
Publications (0)
Data not yet available
No reference posted for this study.