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Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism

This study has been terminated.
(Recruitment was at a standstill. We are currently preparing our results for publication.)
Sponsor:
Information provided by (Responsible Party):
William Crowley, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00064987
First received: July 16, 2003
Last updated: July 5, 2017
Last verified: July 2017
Results First Received: April 3, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hypogonadism
Kallmann Syndrome
Interventions: Procedure: Testicular biopsy
Drug: gonadotropin releasing hormone (GnRH)
Drug: follicle stimulating hormone (FSH)

  Participant Flow
  Hide 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
Two subjects were deemed ineligible for the study. One subject was lost to follow up before being assigned to Group 1 or Group 2.

Reporting Groups
  Description
Group 1 (FSH) Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
Group 2 (GnRH) Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.

Participant Flow:   Overall Study
    Group 1 (FSH)   Group 2 (GnRH)
STARTED   10   6 
COMPLETED   7   6 
NOT COMPLETED   3   0 
Physician Decision                3                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.
No text entered.

Reporting Groups
  Description
Group 1 (FSH) Patients in Group 1 will receive subcutaneous FSH injections daily, titrated to achieve a FSH level of 4-8 IU/L, for 4 months. Patients will then receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion.
Group 2 (GnRH) Patients in Group 2 will receive GnRH therapy for 18 months. GnRH will be administered via a portable infusion pump at 2-hour intervals to stimulate endogenous LH secretion. Patients in Group 2 will not receive prior FSH administration.
Total Total of all reporting groups

Baseline Measures
   Group 1 (FSH)   Group 2 (GnRH)   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   6   16 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      6 100.0%      16 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      10 100.0%      6 100.0%      16 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      10 100.0%      6 100.0%      16 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  20.0%      0   0.0%      2  12.5% 
White      8  80.0%      6 100.0%      14  87.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   10   6   16 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   LH   [ Time Frame: month 4 of GnRH treatment ]

2.  Primary:   FSH   [ Time Frame: month 4 of GnRH treatment ]

3.  Primary:   Testosterone   [ Time Frame: month 4 of GnRH treatment ]

4.  Primary:   Inhibin B   [ Time Frame: month 4 of GnRH treatment ]

5.  Primary:   Testicular Size (Volume)   [ Time Frame: at baseline and month 4 of GnRH treatment ]

6.  Primary:   Sperm Count   [ Time Frame: month 4 of GnRH treatment ]

7.  Secondary:   Fertility   [ Time Frame: 24 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
No text entered.


  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: Dr. William Crowley
Organization: Massachusetts General Hospital
phone: 617-724-2470
e-mail: wcrowley@partners.org


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

Responsible Party: William Crowley, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00064987     History of Changes
Other Study ID Numbers: U54HD028138-457
U54HD028138 ( U.S. NIH Grant/Contract )
Study First Received: July 16, 2003
Results First Received: April 3, 2017
Last Updated: July 5, 2017