5-Alpha Reductase and Anabolic Effects of Testosterone

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Endo Pharmaceuticals
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00475501
First received: April 16, 2007
Last updated: June 27, 2014
Last verified: June 2014
Results First Received: November 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Male Hypogonadism
Muscle Atrophy
Benign Prostate Hypertrophy
Sarcopenia
Interventions: Drug: Testosterone Enanthate
Drug: Finasteride

  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
Subjects were recruited between 7/2/2007 and 10/13/2010. Subjects responded to letters mailed to male patients aged 60 years or more who were seen at VA clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were excluded if they failed brief cognitive testing (MiniCog), if serum testosterone > 300 ng/dL or less and bio-testosterone > 70 ng/dL, congestive heart failure, sleep apnea, hematocrit (HCT) > 49%, prostate specific antigen (PSA) > 2.6 ng/ml, were taking coumadin or had orthopedic limitations.

Reporting Groups
  Description
Arm 1

testosterone enanthate

Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks

Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.

Arm 2

finasteride

Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.

Finasteride : 5 mg, oral, once/day, for 52 weeks

Arm 3

testosterone enanthate + finasteride

Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks

Finasteride : 5 mg, oral, once/day, for 52 weeks

Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.

Arm 4

placebo

Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.


Participant Flow:   Overall Study
    Arm 1     Arm 2     Arm 3     Arm 4  
STARTED     14     13     17     16  
COMPLETED     7     8     13     12  
NOT COMPLETED     7     5     4     4  



  Baseline Characteristics
  Hide 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.
Men aged over 60 with serum testosterone 300 ng/dL or biotestosterone 70 ng/dL or less were recruited

Reporting Groups
  Description
Testosterone Vehicle 125 mg testosterone enanthate/week i.m. daily placebo pill
Vehicle Finasteride weekly vehicle injection 5 mg finasteride/day p.o.
Testosterone Finasteride 125 mg testosterone enanthate/week i.m. 5 mg finasteride/day p.o.
Vehicle Placebo weekly vehicle injection daily placebo pill
Total Total of all reporting groups

Baseline Measures
    Testosterone Vehicle     Vehicle Finasteride     Testosterone Finasteride     Vehicle Placebo     Total  
Number of Participants  
[units: participants]
  14     13     17     16     60  
Age  
[units: years]
Mean ± Standard Deviation
  69.2  ± 8.0     69.5  ± 9.2     64.2  ± 4.8     70.8  ± 9.7     68.25  ± 8.29  
Gender  
[units: participants]
         
Female     0     0     0     0     0  
Male     14     13     17     16     60  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   1 Repetition Maximum (1-RM) Strength Testing   [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]

2.  Secondary:   Grip Strength kg   [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]

3.  Secondary:   Lumbar Spine L2-L4 Bone Mineral Density   [ Time Frame: baseline, 12 months ]

4.  Secondary:   Geriatric Depression Scale   [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]

5.  Secondary:   30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test   [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]

6.  Secondary:   Trail-Making Test, Part A   [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]

7.  Secondary:   Benton Judgment of Line Orientation Test   [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]

8.  Secondary:   Hematocrit   [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]

9.  Secondary:   Dietary Protein Intake   [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]

10.  Secondary:   Transrectal Ultrasound Sizing of Prostate   [ Time Frame: baseline, 6 month, 12 months ]

11.  Secondary:   Life Satisfaction   [ Time Frame: baseline, 3 months, 6 months, 9 months, 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stephen Borst, Ph.D
Organization: Geriatric Research Education and Clinical Center
phone: 352-374-6114 ext 5033
e-mail: stephen.borst@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00475501     History of Changes
Other Study ID Numbers: ENDA-014-05F, VA Merit Award
Study First Received: April 16, 2007
Results First Received: November 20, 2013
Last Updated: June 27, 2014
Health Authority: United States: Federal Government