Efficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction
NCT ID: NCT01810575
Last Updated: 2014-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2013-02-28
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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WC3036-11F/Alprostadil in Vehicle 2.5%
Treatment A
WC3036-11F/Alprostadil in Vehicle 2.5%
330 mcg alprostadil in 2.5% vehicle
WC3036-12F/Alprostadil in Vehicle 0.5%
Treatment B
WC3036-12F/Alprostadil in Vehicle 0.5%
330 mcg alprostadil in 0.5% vehicle
WC3036-13P/Vehicle Only 0.5%
Treatment C
WC3036-13P/Vehicle Only 0.5%
100 mg cream vehicle 0.5%.
Interventions
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WC3036-11F/Alprostadil in Vehicle 2.5%
330 mcg alprostadil in 2.5% vehicle
WC3036-12F/Alprostadil in Vehicle 0.5%
330 mcg alprostadil in 0.5% vehicle
WC3036-13P/Vehicle Only 0.5%
100 mg cream vehicle 0.5%.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
40 Years
MALE
No
Sponsors
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Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Vilma Sniukiene, MD
Role: STUDY_DIRECTOR
Warner Chilcott
Locations
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Warner Chilcott Investigational Study Site
Purchase, New York, United States
Countries
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Other Identifiers
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PR-13311
Identifier Type: -
Identifier Source: org_study_id
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