Efficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction
Information source: Warner Chilcott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: WC3036-11F/Alprostadil in Vehicle 2.5% (Drug); WC3036-12F/Alprostadil in Vehicle 0.5% (Drug); WC3036-13P/Vehicle Only 0.5% (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Warner Chilcott Official(s) and/or principal investigator(s): Vilma Sniukiene, MD, Study Director, Affiliation: Warner Chilcott
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.
Clinical Details
Official title: A Study to Assess the Relative Efficacy and Safety of a Single Dose of Alprostadil Cream Combined With 2 Concentrations of WC3036 Compared to Vehicle in Subjects With Erectile Dysfunction
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Penile rigidityPenile rigidity Penile rigidity
Secondary outcome: Quality of erectionQuality of erection Quality of erection
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Warner Chilcott Investigational Study Site, Purchase, New York 10755, United States
Additional Information
Starting date: February 2013
Last updated: August 8, 2014
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