Trial Outcomes & Findings for An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext (NCT NCT00958893)
NCT ID: NCT00958893
Last Updated: 2014-08-25
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
three 4 month cycles separated by off-drug intervals
Results posted on
2014-08-25
Participant Flow
Participant milestones
| Measure |
25 mg Proellex
25 mg Proellex: one 25 mg capsules
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
25 mg Proellex
25 mg Proellex: one 25 mg capsules
|
|---|---|
|
Overall Study
Study prematurely terminated
|
4
|
Baseline Characteristics
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: three 4 month cycles separated by off-drug intervalsOutcome measures
Outcome data not reported
Adverse Events
25 mg Proellex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- 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