Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

Repros Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Uterine Fibroids

Treatments: Drug: Proellex

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069120

ZPU-307

Details and patient eligibility

About

Safety and efficacy study of 25 and 50 mg doses of Proellex

Full description

The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.

Enrollment: 27 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
• Subject has a menstrual cycle lasting from 20 to 40 days.
• Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Exclusion criteria

• Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
• Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

50 mg Proellex®

Active Comparator group

Description:

2, 25 mg capsules

Treatment:

Drug: Proellex

Drug: Proellex

25 mg Proellex®

Active Comparator group

Description:

1, 25 mg capsule

Treatment:

Drug: Proellex

Drug: Proellex