Efficacy and Safety Evaluating Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors
- Conditions
- HypogonadismErectile Dysfunction
- Registration Number
- NCT00415571
- Lead Sponsor
- QuatRx Pharmaceuticals Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 72
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Office of Stephen Miller
🇺🇸Las Vegas, Nevada, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
HealthStar Research
🇺🇸Hot Springs, Arkansas, United States
Genesis Research International
🇺🇸Longwood, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Hamilton Urology
🇺🇸Hamilton, New Jersey, United States
Center for Urologic Research of WNY, LLC
🇺🇸Williamsville, New York, United States
Urology Associates, P.C.
🇺🇸Nashville, Tennessee, United States
Metrolina Urology Clinic
🇺🇸Charlotte, North Carolina, United States
NorthEast Urology research
🇺🇸Concord, North Carolina, United States
Regional Urology
🇺🇸Shreveport, Louisiana, United States
Radiant Research
🇺🇸San Antonio, Texas, United States