Trial Outcomes & Findings for Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids (NCT NCT01069120)
NCT ID: NCT01069120
Last Updated: 2014-08-21
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
27 participants
Primary outcome timeframe
During two 4 month treatment periods
Results posted on
2014-08-21
Participant Flow
Participant milestones
| Measure |
Proellex®
25 or 50 mg capsules once per day
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Proellex®
25 or 50 mg capsules once per day
|
|---|---|
|
Overall Study
Study prematurely terminated
|
27
|
Baseline Characteristics
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: During two 4 month treatment periodsOutcome measures
Outcome data not reported
Adverse Events
50 mg Proellex®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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