Phase 3
N=62
PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01327495 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Prostate Tissue DHT Concentrations After Treatment — 4.05; 4.26; 2.99; 3.88 ng/g
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- placebo acyline (Other); placebo gel (Other); Testosterone 1% gel 1.25 g (Drug); Testosterone 1% gel 2.5 g (Drug); Testosterone 1% gel 5.0 g (Drug); testosterone 1% gel 10 g (Drug); testosterone 1% gel 15 g (Drug); Acyline (Drug)
- Age
- Adult · 25+ yrs
- Sex
- Male
- Sponsor
- University of Washington
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prostate Tissue DHT Concentrations After Treatment |
4.05; 4.26; 2.99; 3.88; 4.12; 5.11 | — |
| PRIMARY Serum Testosterone |
4.6; 1.9; 3.4; 3.5; 6.1; 7.7 | — |
| PRIMARY Dihydrotestosterone (DHT) |
0.3; 0.6; 0.9; 1.0; 1.5; 1.8 | — |
| PRIMARY Prostate Tissue Testosterone Concentrations After Treatment |
0.3; 0.13; 0.125; 0.18; 0.195; 0.3 | — |
| SECONDARY Prostate Specific Antigen |
0.82; 0.48; 0.61; 0.58; 0.52; 0.76 | — |
| SECONDARY Prostate Volume |
19; 18; 19; 15; 16; 20 | — |
| SECONDARY International Prostate Symptom Score (IPSS) |
1; 2; 2.5; 0; 2.5; 4 | — |
Summary
The investigators will conduct a three-month, randomized, placebo-controlled trial comparing the effects of increasing doses of androgen supplementation with Testosterone (T) gel on the prostate in healthy men who are treated with acyline to block gonadal androgen production.
Eligibility Criteria
Inclusion Criteria
In good health, without severe systemic illness (i.e., renal, liver, cardiac or lung disease, cancer, insulin dependent diabetes)
- Male between the ages of 25 and 55 years old
- Able to understand and comply with protocol instructions and requirements
- International Prostate Symptom Score (IPSS) 320 pounds or BMI > 40
- PSA Level > 2.1
Data sourced from ClinicalTrials.gov (NCT01327495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.