Enrollment of the 24 patients will commence at two sites in the New York City area shortly. All subjects will have been previously diagnosed with secondary hypogonadism and treated with topical testosterone for at least six months but not more than two years.
Patients will be instructed to discontinue their topical testosterone use and return to the clinic within seven to 21 days. If their morning testosterone is less than 300ng/dl, they will be randomized to either Androxal or Testim. Patients will be treated for six months with results assessed at both the three and six month time points.
The primary endpoints for the study will be the change in semen volume, sperm count and motility from baseline comparing the Androxal and Testim groups. Secondary endpoints will consist of changes in pituitary hormones as well as testosterone.
Joseph Podolski, president and CEO of Repros, said: “We believe that Androxal can provide an effective option for men with low testosterone who wish to preserve their fertility. Our goal is to request an end of Phase II meeting with the FDA once this study is completed before moving into Phase III studies.”