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Trial record 2 of 3 for:    8968017 [PUBMED-IDS]

Effect of Dihydrotestosterone (DHT) on Prostate Tissue [Short Title: DHT-3] (DHT-3)

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.
ClinicalTrials.gov Identifier: NCT00490022
Recruitment Status : Completed
First Posted : June 22, 2007
Results First Posted : June 9, 2011
Last Update Posted : June 27, 2011
Sponsor:
Collaborators:
National Institute on Aging (NIA)
ASCEND Therapeutics
Information provided by:
University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: Dihydrotestosterone (DHT) gel (0.7%)
Drug: Placebo gel
Enrollment 31
Recruitment Details Up to 55 normal, healthy men between the ages of 35-55 will be recruited for this study. All subject activities will occur at the University of Washington in Seattle Washington.
Pre-assignment Details Subjects must meet all study protocol inclusion criteria such as informed consent, normal lab values, normal physical examination and normal prostate ultrasound, and not have exclusion criteria such as a first degree relative with or personal history of prostate cancer, PSA >2.0 or a history of a bleeding disorder or need for anticoagulation.
Arm/Group Title Placebo DHT Gel DHT Gel
Hide Arm/Group Description Placebo gel for one month DHT gel (70 mg/day) for one month
Period Title: Overall Study
Started 16 15
Completed 15 12
Not Completed 1 3
Reason Not Completed
Adverse Event             0             2
Withdrawal by Subject             1             0
Subject failed to disclose concommitant             0             1
Arm/Group Title Placebo DHT Gel DHT Gel Total
Hide Arm/Group Description Placebo gel for one month DHT gel (70 mg/day) for one month Total of all reporting groups
Overall Number of Baseline Participants 16 15 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
15
 100.0%
31
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 31 participants
44.4  (6.7) 42.7  (1.6) 43.6  (4.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
16
 100.0%
15
 100.0%
31
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 15 participants 31 participants
16 15 31
1.Primary Outcome
Title Prostate Tissue DHT and Testosterone Levels After 28 Days of Treatment With Dihydrotestosterone [DHT] Gel Versus Placebo Gel.
Hide Description After 4 weeks of either daily dihydrotestosterone transdermal gel or placebo gel, subjects underwent a prostate biopsy. Intraprostatic hormone concentrations, specifically DHT and Testosterone, were measured. Unit of measure is ng/g.
Time Frame 28-days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo DHT Gel DHT Gel
Hide Arm/Group Description:
Placebo gel for one month
DHT gel (70 mg/day) for one month
Overall Number of Participants Analyzed 15 12
Mean (Standard Deviation)
Unit of Measure: ng/g
DHT concentrations 2.8  (0.2) 3.1  (0.5)
Testosterone Concentrations 0.6  (0.2) 0.4  (0.1)
2.Secondary Outcome
Title Prostate Epithelial Cell Proliferation
Hide Description Prostate epithelial cell proliferation in the prostate biopsy tissue was measured using Ki-67 immunohistochemical staining of prostate epithelium as a marker of cell proliferation (values are number of Ki-67 positive stained cells per 100 prostate epithelial cells). The placebo and treatment groups were compared.
Time Frame 28-days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo DHT Gel DHT Gel
Hide Arm/Group Description:
Placebo gel for one month
DHT gel (70 mg/day) for one month
Overall Number of Participants Analyzed 15 12
Mean (Standard Deviation)
Unit of Measure: #pos.Ki-67cells per100 prst. epth cells
1.3  (0.5) 0.7  (0.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo DHT Gel DHT Gel
Hide Arm/Group Description Placebo gel for one month DHT gel (70 mg/day) for one month
All-Cause Mortality
Placebo DHT Gel DHT Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo DHT Gel DHT Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      1/15 (6.67%)    
Gastrointestinal disorders     
Rectal Bleed  0/16 (0.00%)  0 1/15 (6.67%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo DHT Gel DHT Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      1/15 (6.67%)    
Renal and urinary disorders     
Urinary Frequency [1]  0/15 (0.00%)  0 1/15 (6.67%)  1
[1]
Subject experienced urinary frequency. It resolved after discontinuation of DHT gel.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Stephanie Page, PhD, MD
Organization: University of Washington
Phone: 206.616.0483
Publications:
Responsible Party: Stephanie T Page, MD, PhD, University of Washington
ClinicalTrials.gov Identifier: NCT00490022     History of Changes
Other Study ID Numbers: 31866-A
1K23AG027238-01A1 ( U.S. NIH Grant/Contract )
First Submitted: June 20, 2007
First Posted: June 22, 2007
Results First Submitted: January 10, 2011
Results First Posted: June 9, 2011
Last Update Posted: June 27, 2011