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PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue (PROS-1)

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ClinicalTrials.gov Identifier: NCT00490555
Recruitment Status : Completed
First Posted : June 22, 2007
Results First Posted : November 15, 2013
Last Update Posted : November 15, 2013
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Stephanie T. Page, 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: Testosterone gel
Drug: Dutasteride
Drug: Depo-Medroxyprogesterone (DMPA)
Other: Placebo Testosterone gel
Other: Placebo dutasteride
Other: Placebo DMPA
Enrollment 32
Recruitment Details Healthy male volunteers, 25-55 yr old, were recruited via advertisement: flyers on University campus and newspaper ads.
Pre-assignment Details  
Arm/Group Title 1) Placebo 2) Testosterone (T) Gel 3) T Gel+Dutasteride 4) T Gel+DMPA
Hide Arm/Group Description Placebo gel + Placebo pill + placebo DMPA Testosterone 1% transdermal gel 10g (Testim)+ placebo pill, daily + placebo DMPA Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA Testosterone 1% transdermal gel 10g, daily + placebo Dutasteride pill, daily + DMPA 300mg injection (IM)
Period Title: Overall Study
Started 8 8 9 7
Completed 8 8 7 7
Not Completed 0 0 2 0
Reason Not Completed
noncompliant with drug administration             0             0             2             0
Arm/Group Title 1) Placebo 2) Testosterone Gel 3) T Gel +Dutasteride 4) T Gel+ DMPA Total
Hide Arm/Group Description Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM) Total of all reporting groups
Overall Number of Baseline Participants 8 8 9 7 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 7 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
8
 100.0%
9
 100.0%
7
 100.0%
32
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 9 participants 7 participants 32 participants
41  (7.72) 37  (6.19) 37  (8.45) 39  (10.11) 39  (3.46)
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 7 participants 32 participants
Female 0 0 0 0 0
Male 8 8 9 7 32
[1]
Measure Description: Male population, per protocol
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 9 participants 7 participants 32 participants
8 8 9 7 32
Luteinizing Hormone (LH)  
Median (Inter-Quartile Range)
Unit of measure:  IU/liter
Number Analyzed 8 participants 8 participants 9 participants 7 participants 32 participants
4.0
(3.5 to 5.6)
3.9
(2.7 to 5.5)
5.3
(4.2 to 6.6)
3.2
(2.7 to 4.0)
4.1
(3.3 to 5.4)
Follical-stimulating hormone (FSH)  
Median (Inter-Quartile Range)
Unit of measure:  IU/liter
Number Analyzed 8 participants 8 participants 9 participants 7 participants 32 participants
3.6
(2.6 to 4.4)
3.3
(2.6 to 3.7)
4.0
(2.4 to 5.5)
2.8
(2.6 to 4.2)
3.4
(2.5 to 4.4)
SHBG  
Median (Inter-Quartile Range)
Unit of measure:  Nmol/liter
Number Analyzed 8 participants 8 participants 9 participants 7 participants 32 participants
33
(24 to 45)
36
(13 to 50)
38
(26 to 52)
33
(17 to 38)
35
(20 to 46)
Testosterone (T) concentration  
Median (Inter-Quartile Range)
Unit of measure:  ng/mL
Number Analyzed 8 participants 8 participants 9 participants 7 participants 32 participants
3.9
(3.8 to 5.0)
3.9
(2.9 to 5.9)
4.8
(3.8 to 6.3)
4.0
(3.0 to 5.8)
4.1
(3.4 to 5.7)
Dihydrotestosterone (DHT)  
Median (Inter-Quartile Range)
Unit of measure:  ng/mL
Number Analyzed 8 participants 8 participants 9 participants 7 participants 32 participants
0.5
(0.4 to 0.5)
0.6
(0.4 to 0.9)
0.7
(0.6 to 1.0)
0.6
(0.4 to 0.8)
0.6
(0.4 to 0.8)
Prostate-Specific Antigen (PSA)  
Median (Inter-Quartile Range)
Unit of measure:  ng/mL
Number Analyzed 8 participants 8 participants 9 participants 7 participants 32 participants
0.7
(0.6 to 1.0)
0.7
(0.4 to 1.1)
0.9
(0.7 to 1.1)
0.5
(0.4 to 0.6)
0.7
(0.5 to 0.9)
Prostate volume  
Median (Inter-Quartile Range)
Unit of measure:  Ml
Number Analyzed 8 participants 8 participants 9 participants 7 participants 32 participants
25
(16 to 29)
15
(14 to 19)
15
(13 to 21)
19
(14 to 21)
18
(14 to 22)
1.Primary Outcome
Title Prostate-specific Antigen (PSA)
Hide Description PSA level week 10 end of treatment
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1) Placebo 2) Testosterone Gel 3) T Gel +Dutasteride 4) T Gel+ DMPA
Hide Arm/Group Description:
Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
Overall Number of Participants Analyzed 8 7 7 7
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
0.8
(0.7 to 1.2)
0.9
(0.3 to 1.2)
0.7
(0.7 to 1.1)
0.4
(0.4 to 0.6)
2.Primary Outcome
Title Testosterone Concentration
Hide Description [Not Specified]
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1) Placebo 2) Testosterone Gel 3) T Gel +Dutasteride 4) T Gel+ DMPA
Hide Arm/Group Description:
Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
Overall Number of Participants Analyzed 8 7 7 7
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
4.0
(2.9 to 5.6)
4.4
(3.2 to 6.2)
7.0
(4.4 to 12.4)
1.8
(1.3 to 2.9)
3.Primary Outcome
Title Dihydrotestosterone (DHT) Concentration
Hide Description [Not Specified]
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1) Placebo 2) Testosterone Gel 3) T Gel +Dutasteride 4) T Gel+ DMPA
Hide Arm/Group Description:
Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
Overall Number of Participants Analyzed 8 7 7 7
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
0.5
(0.4 to 0.6)
1.8
(1.2 to 2.5)
0.5
(0.3 to 0.5)
0.6
(0.2 to 1.8)
4.Secondary Outcome
Title Androstenedione (AED)
Hide Description [Not Specified]
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1) Placebo 2) Testosterone Gel 3) T Gel +Dutasteride 4) T Gel+ DMPA
Hide Arm/Group Description:
Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
Overall Number of Participants Analyzed 8 7 7 7
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
0.9
(0.8 to 1.1)
0.9
(0.8 to 1.3)
1.8
(1.3 to 3.7)
0.7
(0.6 to 1.0)
5.Secondary Outcome
Title Dehydroepiandrosterone (DHEA)
Hide Description [Not Specified]
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1) Placebo 2) Testosterone Gel 3) T Gel +Dutasteride 4) T Gel+ DMPA
Hide Arm/Group Description:
Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
Overall Number of Participants Analyzed 8 7 7 7
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
4.3
(2.7 to 5.5)
3.5
(2.0 to 7.5)
3.8
(3.8 to 6.3)
3.2
(2.1 to 4.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1) Placebo 2) Testosterone Gel 3) T Gel +Dutasteride 4) T Gel+ DMPA
Hide Arm/Group Description Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
All-Cause Mortality
1) Placebo 2) Testosterone Gel 3) T Gel +Dutasteride 4) T Gel+ DMPA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1) Placebo 2) Testosterone Gel 3) T Gel +Dutasteride 4) T Gel+ DMPA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/7 (0.00%)      0/9 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1) Placebo 2) Testosterone Gel 3) T Gel +Dutasteride 4) T Gel+ DMPA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      2/7 (28.57%)      1/9 (11.11%)      1/7 (14.29%)    
General disorders         
Fatigue  1/8 (12.50%)  1 0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0
headache  0/8 (0.00%)  0 1/7 (14.29%)  1 0/9 (0.00%)  0 1/7 (14.29%)  1
Skin and subcutaneous tissue disorders         
rash  0/8 (0.00%)  0 1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0
abscess [1]  0/8 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0
[1]
leg abscess - unrelated trauma
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. Stephanie Page
Organization: University of Washington
Phone: 2066160483
Publications:
Wilson JD, George FW. The Physiology of Reproduction. Raven Press, 1994
Responsible Party: Stephanie T. Page, University of Washington
ClinicalTrials.gov Identifier: NCT00490555     History of Changes
Other Study ID Numbers: 31434-A
RFA-HD-06-014;
06-4795-A 01 ( Other Identifier: University of Washington IRB (old application number) )
First Submitted: June 20, 2007
First Posted: June 22, 2007
Results First Submitted: June 19, 2013
Results First Posted: November 15, 2013
Last Update Posted: November 15, 2013