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 (H-28941)
Peyronie's disease is an inflammatory condition of the penis that can cause curvature with erection, painful erections, and nodules that can be felt through the skin. The curvature may be so severe that it interferes with sexual activity. Peryronie's disease usually occurs in the middle years, but can occur in some young men.
New evidence indicates that Peyronie's disease may be linked with testosterone deficiency. Testosterone is a hormone made in the testicles that plays a key role in the development of male reproductive tissues and sex characteristics such as bone, muscle, and body hair growth.
A recent study demonstrated that 74 percent of men presenting with Peyronie's disease had evidence of low testosterone on lab tests. Moreover, those with lower testosterone had more severe Peyronie's disease.
This study will investigate if testosterone therapy is beneficial in combination with Vitamin D and E compared to Vitamin D and E alone in the treatment of Peyronie's disease in men 18 to 70 years of age.