Xiaflex® Plus Testosterone Treatment Pilot Study Protocol

PHASE4CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 14, 2019

Primary Completion Date

December 29, 2020

Study Completion Date

December 30, 2020

Conditions
Peyronie's Disease (PD)
Interventions
DRUG

Xiaflex®

medication indicated for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. Xiaflex belongs to a family of enzymes called collagenases. Collagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiological conditions, resulting in lysis of collagen deposits. The signs and symptoms of Peyronie's disease are caused by a collagen plaque. Injection of XIAFLEX into a Peyronie's plaque, which is comprised mostly of collagen, may result in enzymatic disruption of the plaque. Following this disruption of the plaque, penile curvature deformity and patient bother caused by Peyronie's disease are reduced

DRUG

Aveed

Aveed® is an FDA-approved medication for treatment of hypogonadism (low testosterone). It is not approved for the treatment of Peyronie's Disease. Aveed® 750 mg/3mL injection will be placed intramuscularly at the beginning of study, at four weeks, at 10 weeks thereafter.

Trial Locations (1)

02467

Men's Health Boston, Chestnut Hill

All Listed Sponsors
lead

Men's Health Boston

OTHER

NCT03815331 - Xiaflex® Plus Testosterone Treatment Pilot Study Protocol | Biotech Hunter | Biotech Hunter