Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Repros Therapeutics Inc.

Criteria

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