Trial Outcomes & Findings for Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females (NCT NCT00787618)
NCT ID: NCT00787618
Last Updated: 2014-08-25
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
48 hours
Results posted on
2014-08-25
Participant Flow
Participant milestones
| Measure |
50 mg Proellex Mild Impairment
50 mg Proellex single dose Female subjects with mild renal impairment function.
50 mg Proellex: Single dose
|
50 mg Proellex Moderate
50 mg Proellex, Female subjects with moderate renal impairment function.
50 mg Proellex: Single dose
|
50 mg Proellex, Normal
50 mg Proellex, Female subjects with normal renal function.
50 mg Proellex: Single dose
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
3
|
|
Overall Study
COMPLETED
|
3
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 48 hoursPopulation: Study prematurely terminated
Outcome measures
Outcome data not reported
Adverse Events
50 mg Proellex Mild Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
50 mg Proellex Moderate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
50 mg Proellex, Normal
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