Efficacy and Safety Evaluating Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors
Completed · Phase 2
Conditions studied: Hypogonadism, Erectile Dysfunction
In brief
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.
Key facts
- Study ID
- NCT00415571
- Run by
- QuatRx Pharmaceuticals Company
- People needed
- 72
- Starts
- 2006-12-01
- Expected to finish
- 2008-08-01
- Last updated by the study team
- 2010-02-03
Who can join
Age: 20 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- Radiant Research — Birmingham, Alabama, 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
- Radiant Research — West Palm Beach, Florida, United States
- Regional Urology — Shreveport, Louisiana, United States
- Office of Stephen Miller — Las Vegas, Nevada, United States
- Hamilton Urology — Hamilton, New Jersey, United States
- Center for Urologic Research of WNY, LLC — Williamsville, New York, United States
- Metrolina Urology Clinic — Charlotte, North Carolina, United States
- NorthEast Urology research — Concord, North Carolina, United States
- Urology Associates, P.C. — Nashville, Tennessee, United States
- Radiant Research — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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