Aromatase Inhibitors in the Treatment of Male Infertility

This study has been terminated.
(Not able meet target enrollment.)
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00440180
First received: February 22, 2007
Last updated: March 8, 2016
Last verified: March 2016
Results First Received: February 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity
Oligospermia
Interventions: Drug: Anastrozole
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo once daily
Anastrozole 1 milligram daily

Participant Flow:   Overall Study
    Placebo     Anastrozole  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Placebo Placebo once daily
Anastrozole 1 milligram daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Anastrozole     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     10     10     20  



  Outcome Measures

1.  Primary:   Pregnancy Rate   [ Time Frame: 4 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Marie Gibson
Organization: University of Utah
phone: 801-213-2845
e-mail: marie.gibson@hsc.utah.edu



Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00440180     History of Changes
Other Study ID Numbers: IRB_00016246
Study First Received: February 22, 2007
Results First Received: February 5, 2016
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration