Aromatase Inhibitors in the Treatment of Male Infertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00440180
Recruitment Status : Terminated (Not able meet target enrollment.)
First Posted : February 26, 2007
Results First Posted : March 7, 2016
Last Update Posted : April 6, 2016
Information provided by (Responsible Party):
University of Utah

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity
Interventions: Drug: Anastrozole
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
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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
Placebo Placebo once daily
Anastrozole 1 milligram daily

Participant Flow:   Overall Study
    Placebo   Anastrozole
STARTED   10   10 
COMPLETED   10   10 

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

Baseline Measures
   Placebo   Anastrozole   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   10   10   20 
>=65 years   0   0   0 
[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

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

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

Responsible Party: University of Utah Identifier: NCT00440180     History of Changes
Other Study ID Numbers: IRB_00016246
First Submitted: February 22, 2007
First Posted: February 26, 2007
Results First Submitted: February 5, 2016
Results First Posted: March 7, 2016
Last Update Posted: April 6, 2016