Clinical Trial: Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: An Open-Label, Nine-Month Randomized Controlled Study of Testosterone (Testopel) Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease

Brief Summary: Two recent studies have identified low levels of serum testosterone in association with Peyronie's Disease (PD), with a significant correlation noted between severity of testosterone deficiency and severity of curvature. The study hypothesis is to determine whether treatment with testosterone may help men with PD and penile curvature.

Detailed Summary:
Sponsor: Men's Health Boston

Current Primary Outcome: penile curvature [ Time Frame: 9 months ]

The primary outcome to be assessed will be the change in penile curvature from baseline.


Original Primary Outcome: Same as current

Current Secondary Outcome: sexual function [ Time Frame: 9 months ]

Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life).


Original Secondary Outcome: Same as current

Information By: Men's Health Boston

Dates:
Date Received: April 12, 2012
Date Started: April 2012
Date Completion: June 2017
Last Updated: April 8, 2015
Last Verified: April 2015