Clinical trial · Interventional
Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms
A Phase III, Open Label, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex to Assess Recurrence of Symptoms in the Treatment of Symptomatic Uterine Fibroids
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated for safety and the FDA put the study on hold for safety.
Summary
Brief summary (as posted)
Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proellex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 25 mg
- description
- 25 mg Proellex
- interventionNames
- Drug: Proellex
- type
- EXPERIMENTAL
- label
- 50 mg
- description
- 50 mg Proellex
- interventionNames
- Drug: Proellex
Primary outcomes (1)
- measure
- To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles
- timeFrame
- Four months each cycle
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU) * Subject must have uterine fibroid-associated symptoms during the-screening visit * Subject has menstrual cycle lasting from 20 to 40 days * Other inclusion criteria may apply Exclusion Criteria: * Post-menopausal women or women likely to become post-menopausal during the study * Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating * Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study. * Subject who has had an acute illness within five days of study medication administration * Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically * Subject with an abnormal screening endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN) * Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at screening
References
Publications (0)
Data not yet available