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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Flutamide and Placebo Control Subjects Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.

Participant Flow:   Overall Study
    Flutamide and Placebo Control Subjects
STARTED   8 [1] 
COMPLETED   5 
NOT COMPLETED   3 
Withdrawal by Subject                3 
[1] Arm assignment can not be determined as study was ended prior to unblinding and no key found.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Flutamide Treated and Placebo Control 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.

Baseline Measures
   Flutamide Treated and Placebo Control 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   8 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   8 
Male   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   0 
More than one race   0 
Unknown or Not Reported   8 
Region of Enrollment 
[Units: Participants]
 
United States   8 


  Outcome Measures

1.  Primary:   DCI-IPG Measurements in Blood and Urine   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: jnestler@mcvh-vcu.edu



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