Status:
COMPLETED
Efficacy and Safety Evaluating Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors
Lead Sponsor:
QuatRx Pharmaceuticals Company
Collaborating Sponsors:
Hormos Medical
Conditions:
Hypogonadism
Erectile Dysfunction
Eligibility:
MALE
20+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00415571
Start Date
December 1 2006
End Date
August 1 2008
Last Update
February 3 2010
Active Locations (14)
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1
Radiant Research
Birmingham, Alabama, United States, 35209
2
Genova Clinical Research
Tucson, Arizona, United States, 85741
3
HealthStar Research
Hot Springs, Arkansas, United States, 71913
4
Genesis Research International
Longwood, Florida, United States, 32779