Efficacy and Safety Evaluating Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: QuatRx Pharmaceuticals Company
• Collaborator: Hormos Medical
• Treatments: Phosphodiesterase 5 Inhibitors; Tamoxifen

Criteria

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.