• Change in the IIEF erectile function domain score from baseline to Week 8/Early Termination;
• Change in total testosterone levels from baseline to Week 8/Early Termination

• Change in the IIEF erectile function domain score from baseline to Week 8/Early Termination
• ;Change in total testosterone levels from baseline to Week 8/Early Termination

• Change in total testosterone levels from baseline to Week 4 and Week 10
• ;Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 4, 8/Early Termination and 10
• ;Change in SHBG, E2, LH, FSH, and testosterone/E2 ratio from baseline to Weeks 4, 8/Early Termination and 10
• ;Change in the IIEF erectile function domain score from baseline to Week 4
• ;Change in other IIEF domain scores from baseline to Weeks 4 and 8/Early Termination
• ;Change in IIEF individual question scores and total score from baseline to Weeks 4 and 8/Early Termination
• ;Proportion of “responders” defined as response of 4 or 5 to questions 3 and 4 of the IIEF at Weeks 4 and 8/Early Termination
• ;Proportion of “improvers” defined as an increase of at least 1 category over baseline for either question 3 or 4 at Weeks 4 and 8/Early Termination
• ;Percentage of subjects with a “YES” responses to the GAQ, when asked at Week 8/Early Termination
• ;Change in serum lipid levels from screening to Week 8/Early Termination

The objective of the study is to assess and compare the preliminary efficacy, safety and tolerability of fispemifene 300 mg and placebo given once daily for 8 weeks in the treatment of hypogonadal men with erectile dysfunction (ED) unresponsive to PDE5 inhibitors.

• Hypogonadism
• Erectile Dysfunction

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Inclusion Criteria:

• Hypogonadal (morning total testosterone levels ≤400 ng/dl) men age ≥20 with ED who are unresponsive to PDE5 inhibitors, as demonstrated by International Index of Erectile Function (IIEF) results for 28-day lead in period.