Clinical trial · Interventional
Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
A Multi-center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response
NCT00683917CI-TRIAL-00015432terminatedPhase 2Results 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 the study for safety and FDA put the study on hold for safety.
Summary
Brief summary (as posted)
PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
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 |
|---|---|---|---|
| Lupron Depot | Drug | Leuprolide | ALIAS |
| Proellex 25 mg | Drug | — | UNRESOLVED |
| Proellex 50 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Proellex 25 mg
- description
- Proellex 25 mg
- interventionNames
- Drug: Proellex 25 mg
- type
- EXPERIMENTAL
- label
- Proellex 50 mg
- description
- Proellex 50 mg
- interventionNames
- Drug: Proellex 50 mg
- type
- ACTIVE_COMPARATOR
- label
- Lupron
- description
- Lupron Depot
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive * Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study * Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding * Regular or steady menstrual cycle lasting from 24 to 36 days * Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits * Subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug Exclusion Criteria: * Documented endometriosis or active pelvic inflammatory disease * History of alcohol and/or drug abuse * Any history or diagnosis of gynecological cancer or cervical dysplasia * Use of an IUD * Use of prohibited concomitant medications: * Use of Depo-Provera must cease 10 months prior to first dose of study drug * Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit * Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia
References
Publications (0)
Data not yet available
No reference posted for this study.