Trial Outcomes & Findings for Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids (NCT NCT00737282)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

175 participants

Primary outcome timeframe

12 months

Results posted on

2014-08-21

Participant milestones
Measure	Proellex Proellex 25 or 50 mg once daily One capsule Proellex 25 mg or 50 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
Overall Study STARTED	175
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	175

Reasons for withdrawal
Measure	Proellex Proellex 25 or 50 mg once daily One capsule Proellex 25 mg or 50 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
Overall Study Study prematurely terminated	175

Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids

Baseline data not reported

Timeframe: 12 months

Population: Study prematurely terminated

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Repros Therapeutics Inc.

Phone: 2817193402

Principal investigator is a sponsor employee Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights
Publication restrictions are in place

Restriction type: OTHER