PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate

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.

Conditions

• Healthy

Interventions

OTHER

placebo acyline

Placebo acyline subcutaneous injection every 2 weeks

OTHER

placebo gel

daily placebo testosterone gel applied transdermally x 12 weeks

DRUG

Testosterone 1% gel 1.25 g

testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks

DRUG

Testosterone 1% gel 2.5 g

Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks

DRUG

Testosterone 1% gel 5.0 g

Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks

DRUG

testosterone 1% gel 10 g

Testosterone 1% gel 10 g daily applied transdermally x 12 weeks

DRUG

testosterone 1% gel 15 g

Testosterone 1% gel 15 g daily applied transdermally x 12 weeks

DRUG

Acyline

300 ug/kg subcutaneous injection every 2 weeks

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute on Aging (NIA)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Stephanie T Page, MD, PhD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

55 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2014-06-30

Completion

2014-12-31

Countries

• United States

Study Locations