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

This phase 2 study is a double-blind, placebo controlled, parallel arm study with a 4 week
run-in and an 8-week treatment period. It will assess the safety and tolerability of
fispemifene, and the effects of treatment on the sexual side effects seen in this patient
population using PRO endpoints.

Inclusion Criteria:

- A confirmed diagnosis of secondary hypogonadism

- Mild to moderate erectile dysfunction

- Ability to read, understand and complete diaries and questionnaires

- Ability to safely make sexual attempts during the course of the study

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