Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease (PD+)
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|ClinicalTrials.gov Identifier: NCT01578473|
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peyronie's Disease||Drug: Vitamin D2 Drug: Vitamin E Drug: Testosterone Pellets||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 23, 2013|
|Actual Primary Completion Date :||July 7, 2013|
|Actual Study Completion Date :||November 13, 2017|
Active Comparator: Vitamin D and E
Oral Vitamin D and E alone in men with penile curvature due to PD.
Drug: Vitamin D2
oral softgel 2000 IU once daily 9 months
Other Name: 21st Century Dietary Supplement
Drug: Vitamin E
oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily
1 softgel of 200 IU daily 9 months
Other Name: GERI-CARE
Active Comparator: Testosterone Pellets and Vitamin D and E
Testosterone in combination with oral Vitamin D an E supplementation in men with penile curvature due to PD.
Drug: Testosterone Pellets
subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months
Other Name: Testopel 75 mg testosterone pellets
- penile curvature [ Time Frame: 9 months ]The primary outcome to be assessed will be the change in penile curvature from baseline.
- sexual function [ Time Frame: 9 months ]Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578473
|United States, Massachusetts|
|Men's Health Boston|
|Chestnut Hill, Massachusetts, United States, 02467|
|Principal Investigator:||Abraham Morgentaler, MD||Men's Health Boston|