Trial Outcomes & Findings for Study to Evaluate Menses Induction in Women Administered Proellex (NCT NCT00881608)
NCT ID: NCT00881608
Last Updated: 2014-08-25
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses
Results posted on
2014-08-25
Participant Flow
Participant milestones
| Measure |
All Subjects Enrolled
All subjects initiated treatment with placebo. Further information is not availasble due to premature termination of the study.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
All Subjects Enrolled
All subjects initiated treatment with placebo. Further information is not availasble due to premature termination of the study.
|
|---|---|
|
Overall Study
Study prematurely terminated
|
11
|
Baseline Characteristics
Study to Evaluate Menses Induction in Women Administered Proellex
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced mensesPopulation: Study prematurely terminated
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At least 2 daysPopulation: Study prematurely terminated
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 mg Proellex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
6 mg Proellex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
12 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