MedTrace Logo

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

NCT01578473 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-03-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Men's Health Boston

    lead OTHER

Principal Investigators

  • Abraham Morgentaler, MD · Men's Health Boston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-23
Primary Completion
2013-07-07
Completion
2017-11-13

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01578473 on ClinicalTrials.gov