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

Uterine Fibroids Clinical Trial

Official title:

A Phase III Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® in the Treatment of Women Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01069120
• Other study ID #: ZPU-307
• Status: Terminated
• Phase: Phase 3
• First received: February 10, 2010
• Last updated: August 5, 2014
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: August 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Proellex
2, 25 mg capsules once per day
• Proellex
1, 25 mg capsule once per day

Locations

Country	Name	City	State
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Advances in Health Inc	Houston	Texas
United States	The Women's Hospital of Texas, Clinical Research Center	Houston	Texas
United States	Insignia Clinical Research (Tampa Bay Women's Center)	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)		During two 4 month treatment periods	Yes