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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 rigidity

Penile rigidity

Penile rigidity

Secondary outcome:

Quality of erection

Quality 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

Page last updated: August 23, 2015

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