Status:
TERMINATED
Efficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction
Lead Sponsor:
Warner Chilcott
Conditions:
Erectile Dysfunction
Eligibility:
MALE
40+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety \& efficacy of a single dose of alprostadil cream with 2 concentrations of WC3036 compared to vehicle alone in men with erectile dysfunction.
Eligibility Criteria
Inclusion
- Male subject aged 40 or older of any race
- History of ED (erectile dysfunction) of at least 3 months duration defined as inability to attain \& maintain an erection of the penis sufficient to permit satisfactory sexual intercourse
- Completed and signed informed consent prior to any study related procedures
Exclusion
- History/presence any significant disease that Investigator feels will interfere with course of the study
- Anatomic deformity of penis
- History/presence alcoholism or drug abuse/dependence within past 2 years (discretion of Investigator)
- Participation in investigational study drug trial within 30 days prior to randomization
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01810575
Start Date
February 1 2013
End Date
April 1 2013
Last Update
August 12 2014
Active Locations (1)
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1
Warner Chilcott Investigational Study Site
Purchase, New York, United States, 10755