Overview

This trial is active, not recruiting.

Condition healthy
Treatment testosterone 1% gel (or placebo) + acyline (or placebo)
Phase phase 2/phase 3
Sponsor University of Washington
Collaborator National Institutes of Health (NIH)
Start date October 2011
End date June 2014
Trial size 72 participants
Trial identifier NCT01327495, 1R01AG037603-01, 39738-A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo acyline every 2 weeks + daily placebo gel x 12 weeks
testosterone 1% gel (or placebo) + acyline (or placebo)
Placebo acyline subcutaneous injection every 2 weeks + daily placebo gel applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 10 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 15 g daily applied transdermally x 12 weeks
(Active Comparator)
Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks
testosterone 1% gel (or placebo) + acyline (or placebo)
Placebo acyline subcutaneous injection every 2 weeks + daily placebo gel applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 10 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 15 g daily applied transdermally x 12 weeks
(Active Comparator)
Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks
testosterone 1% gel (or placebo) + acyline (or placebo)
Placebo acyline subcutaneous injection every 2 weeks + daily placebo gel applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 10 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 15 g daily applied transdermally x 12 weeks
(Active Comparator)
Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks
testosterone 1% gel (or placebo) + acyline (or placebo)
Placebo acyline subcutaneous injection every 2 weeks + daily placebo gel applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 10 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 15 g daily applied transdermally x 12 weeks
(Active Comparator)
Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks
testosterone 1% gel (or placebo) + acyline (or placebo)
Placebo acyline subcutaneous injection every 2 weeks + daily placebo gel applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 10 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 15 g daily applied transdermally x 12 weeks
(Active Comparator)
Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks
testosterone 1% gel (or placebo) + acyline (or placebo)
Placebo acyline subcutaneous injection every 2 weeks + daily placebo gel applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 10 g daily applied transdermally x 12 weeks Acyline subcutaneous injection (300µg/kg every two weeks) + testosterone 1% gel 15 g daily applied transdermally x 12 weeks

Primary Outcomes

Measure
Prostate tissue DHT concentrations after treatment
time frame: A prostate biopsy will be performed at week 12 to measure intraprostatic dihydrotestosterone [DHT] levels.

Eligibility Criteria

Male participants from 25 years up to 55 years old.

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) <11 - Agrees to not donate blood during the study - Normal serum total T, LH, FSH, urine analysis, COMP, CBC and sperm count Exclusion Criteria: - History of, or current breast cancer or prostate cancer - Clinically significant findings on digital rectal exam such as nodules, areas of induration or any other malignancy or abnormal prostate ultrasound - History of invasive therapy for BPH - Current or past treatment with a 5α-reductase inhibitor - History of drug or alcohol abuse within the past 12 months - History of a bleeding disorder or anticoagulation - Skin disease that might interfere with T-gel absorption - Participation in another drug study in the past 3 months - A first-degree relative (i.e. father, brother) with a history of prostate cancer - History of infertility or desire for fertility within 6 months, or current pregnant female partner - Weight >320 pounds or BMI > 40 - PSA Level > 2.1

Additional Information

Official title Dose Response Effects of Exogenous Testosterone on the Prostate and Comparison With Effects on Body Composition (Short Title: PROS-2)
Principal investigator Stephanie T Page, MD, PhD
Description The investigators overall goals are (i) to determine the relationship between serum and prostate tissue hormone concentrations in men in response to increasing doses of exogenous androgens; (ii) to determine the impact that alterations in serum and tissue testosterone concentrations have on prostate epithelial cell function and phenotype; and (iii) to determine the relationships between prostatic androgens and alterations in the tissue microenvironment. The investigators will perform a study in healthy, middle-aged men to address the following Specific Aims: Specific Aims: To compare the dose-response relationships between serum testosterone and intraprostatic androgens and androgen action, and serum testosterone and anabolic activity in healthy, middle-aged men. Hypothesis: The investigators hypothesize that very low levels of serum testosterone will lower concentrations of intraprostatic testosterone and dihydrotestosterone (DHT). However, when serum testosterone concentrations are within or even above the normal range there will be no significant increases in intraprostatic testosterone and dihydrotestosterone. In contrast, the investigators expect that anabolic activity will increase with increasing concentrations of circulating testosterone. Secondarily, the investigators hypothesize that increasing levels of serum testosterone beyond the low normal range will have little impact on androgen action within the prostate. Approach: The investigators will conduct a randomized, placebo-controlled trial in healthy men who are medically castrated and administered one of five different doses of testosterone gel (Androgel) for 12 weeks.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University of Washington.