Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease

PHASE4RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 11, 2024

Primary Completion Date

October 31, 2029

Study Completion Date

October 31, 2029

Conditions
Peyronie Disease
Interventions
DRUG

Collagenase Clostridium Histolyticum

"4 Series given to each participant, 6 weeks apart. Medication administered on back-to-back days. If failing to achieve an adequate response, men may receive up to 2 additional series 9-12 months after the 4th series.~Total of 0.9 mg administered with each series, diluted to 0.8 mL"

DEVICE

RestoreX

Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final CCH series.

DRUG

Sildenafil

Men will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.

Trial Locations (1)

84057

RECRUITING

Male Fertility and Peyronie's Clinic, Orem

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Endo Pharmaceuticals

INDUSTRY

lead

Charitable Union for the Research and Education of Peyronie's Disease

OTHER