Clinical Trial: Peyronie's Disease Treatment Protocol

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Sequential, Randomized, Double-blind, Placebo-controlled, Prospective Study to Evaluate the Safety and Efficacy of the H-100 Treatment in Adult Male Volunteers With Peyronie's

Brief Summary: Treatment of Peyronie's disease remains difficult. The purpose of this study is to test the safety and efficacy of a new compound to treat this disease.

Detailed Summary:
Sponsor: Hybrid Medical

Current Primary Outcome: Safety measure [ Time Frame: Up to six months ]

Number of participants with adverse events. Continuous monitoring for adverse events. An adverse event is the development of an undesirable medical condition - e.g. symptoms or abnormal results of an investigation - or the deterioration of a pre-existing medical condition (not relevant in this study). Per the subject description, adverse events will be reported as: mild, moderate or severe.


Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy measure [ Time Frame: Up to three and six months (the Placebo group will change from Placebo to H-100 at the end of three months) ]

Measure for change in pain, curvature, length, plaque hardness and plaque size. At the end of three months the Placebo group will change from Placebo to H-100 for the remaining three months. The H-100 group will receive H-100 for six months.

Monitor for adverse events.



Original Secondary Outcome: Same as current

Information By: Hybrid Medical

Dates:
Date Received: July 9, 2013
Date Started: June 2013
Date Completion:
Last Updated: February 24, 2014
Last Verified: February 2014