NCT01578473

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Men's Health Boston · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Peyronie's Disease

Interventions

Type	Name	Description
DRUG	Vitamin D2	oral softgel 2000 IU once daily 9 months
DRUG	Vitamin E	oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily 1 softgel of 200 IU daily 9 months
DRUG	Testosterone Pellets	subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months

Timeline

• Start date: 2013-05-23
• Primary completion: 2013-07-07
• Completion: 2017-11-13
• First posted: 2012-04-17
• Last updated: 2018-03-29

Locations

1 site across 1 country: United States