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Trial record 8 of 30 for:    nichd Polycystic Ovary Syndrome (PCOS)

Effects of Flutamide on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome (PCOS)

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ClinicalTrials.gov Identifier: NCT00729560
Recruitment Status : Terminated (Lack of recruitment)
First Posted : August 7, 2008
Results First Posted : September 8, 2014
Last Update Posted : September 8, 2014
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Health Services Research
Condition Polycystic Ovary Syndrome
Interventions Drug: Flutamide
Drug: Placebo
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Flutamide and Placebo Control Subjects
Hide Arm/Group Description Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
Period Title: Overall Study
Started 8 [1]
Completed 5
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
[1]
Arm assignment can not be determined as study was ended prior to unblinding and no key found.
Arm/Group Title Flutamide Treated and Placebo Control
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
8
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
8
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title DCI-IPG Measurements in Blood and Urine
Hide Description zero participants analyzed, no assays performed
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flutamide and Placebo Control Subjects
Hide Arm/Group Description:
Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flutamide Treated and Placebo Control Subjects
Hide Arm/Group Description Flutamide: 250 mg twice daily for 4 weeks or Placebo: twice daily for 4 weeks
All-Cause Mortality
Flutamide Treated and Placebo Control Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Flutamide Treated and Placebo Control Subjects
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Flutamide Treated and Placebo Control Subjects
Affected / at Risk (%)
Total   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. John Nestler
Organization: Virginia Commonwealth University
Phone: 804-828-3389
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00729560     History of Changes
Other Study ID Numbers: 04487VCUIRB
GCRC0826
First Submitted: August 5, 2008
First Posted: August 7, 2008
Results First Submitted: May 27, 2014
Results First Posted: September 8, 2014
Last Update Posted: September 8, 2014