Trial Outcomes & Findings for Effects of Flutamide on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome (NCT NCT00729560)
NCT ID: NCT00729560
Last Updated: 2014-09-08
Results Overview
zero participants analyzed, no assays performed
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
2 years
Results posted on
2014-09-08
Participant Flow
Participant milestones
| Measure |
Flutamide and Placebo Control Subjects
Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Flutamide and Placebo Control Subjects
Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Effects of Flutamide on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome
Baseline characteristics by cohort
| Measure |
Flutamide Treated and Placebo Control
n=8 Participants
Flutamide treated: 250 mg twice daily for 4 weeks or Placebo control: twice daily for 4 weeks. Study was terminated due to insufficient enrollment. Randomization is unknown as study was terminated prior to unblinding and no key can be found. Consequently, we are unable to differentiate between treated and control subjects.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearszero participants analyzed, no assays performed
Outcome measures
Outcome data not reported
Adverse Events
Flutamide Treated and Placebo Control Subjects
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
- Publication restrictions are in place