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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
oral softgel 2000 IU once daily 9 months
oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily 1 softgel of 200 IU daily 9 months
subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months
Men's Health Boston
Chestnut Hill, Massachusetts, United States
penile curvature
The primary outcome to be assessed will be the change in penile curvature from baseline.
Time frame: 9 months
sexual function
Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life).
Time frame: 9 months
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