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Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00850564
First Posted: February 25, 2009
Last Update Posted: April 19, 2011
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.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Massachusetts General Hospital
Results First Submitted: March 3, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Healthy Volunteers
Intervention: Drug: Growth Hormone Releasing Hormone (Tesamorelin)

  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
recruitment from March 2009 through March 2010

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
Growth Hormone Releasing Hormone (Tesamorelin) Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily

Participant Flow:   Overall Study
    Growth Hormone Releasing Hormone (Tesamorelin)
STARTED   15 
COMPLETED   13 
NOT COMPLETED   2 
Withdrawal by Subject                2 



  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.
No text entered.

Reporting Groups
  Description
Growth Hormone Releasing Hormone (Tesamorelin) Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily

Baseline Measures
   Growth Hormone Releasing Hormone (Tesamorelin) 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   15 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 44  (13) 
Gender 
[Units: Participants]
 
Female   0 
Male   15 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Overnight Growth Hormone   [ Time Frame: at 2 weeks (i.e., after 2 weeks of treatment) ]

2.  Secondary:   Insulin Stimulated Glucose Utilization   [ Time Frame: at 2 weeks (i.e., after 2 weeks of treatment) ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Steven Grinspoon, MD
Organization: Massachusetts General Hospital
phone: 617-724-9109
e-mail: sgrinspoon@partners.org


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00850564     History of Changes
Other Study ID Numbers: DK63639B
R01DK063639 ( U.S. NIH Grant/Contract )
First Submitted: February 23, 2009
First Posted: February 25, 2009
Results First Submitted: March 3, 2011
Results First Posted: March 30, 2011
Last Update Posted: April 19, 2011