Trial Outcomes & Findings for Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids (NCT NCT00785356)
NCT ID: NCT00785356
Last Updated: 2014-08-21
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
8 participants
Primary outcome timeframe
3 months
Results posted on
2014-08-21
Participant Flow
Participant milestones
| Measure |
All Groups
Proellex 25 mg, Proellex 50 mg, 1placebo
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
All Groups
Proellex 25 mg, Proellex 50 mg, 1placebo
|
|---|---|
|
Overall Study
Study prematurely terminated
|
8
|
Baseline Characteristics
Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 3 monthsOutcome measures
Outcome data not reported
Adverse Events
25 mg Proellex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Proellex 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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