Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men

Exclusion Criteria

• •Primary hypogonadism
• •Hypogonadism as a result of surgery, trauma, tumors or radiation of the hypothalamus or pituitary
• •History or current diagnosis of breast cancer, prostate cancer and/or PSA level above ≥3.5 ng/mL
• •Poorly controlled blood pressure, type 2 diabetes, thyroid disease; sleep apnea
• •Elevated prolactin level
• •Hemoglobin \>17 g/dL or Hematocrit \>50%
• •Use of transdermal or oral testosterone within 4 weeks, intramuscular testosterone therapy within 6 weeks, and testosterone pellets within 6 months prior to Screening and at any time throughout the study
• •Use of another SERM or past participation in a trial with Fispemifene
• •Use of medications known to alter the HPG axis
• •Clinically significant findings on physical exam, screening labs, or other findings which would prevent safe participation in the study
• •Participation in another clinical study in the last 30 days