Efficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction

Phase 2

Terminated

• Conditions: Erectile Dysfunction
• Interventions: Drug: WC3036-11F/Alprostadil in Vehicle 2.5%; Drug: WC3036-12F/Alprostadil in Vehicle 0.5%; Drug: WC3036-13P/Vehicle Only 0.5%

• Registration Number: NCT01810575
• Lead Sponsor: Warner Chilcott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Disposition First Submitted: 2014-06-16
• Disposition First Submitted QC: 2014-07-14
• Disposition First Posted: 2014-07-16
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-08
• Last Update Posted: 2014-08-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
WC3036-11F/Alprostadil in Vehicle 2.5%	WC3036-11F/Alprostadil in Vehicle 2.5%	Treatment A
WC3036-12F/Alprostadil in Vehicle 0.5%	WC3036-12F/Alprostadil in Vehicle 0.5%	Treatment B
WC3036-13P/Vehicle Only 0.5%	WC3036-13P/Vehicle Only 0.5%	Treatment C

Primary Outcome Measures

Name	Time	Method
Penile rigidity	Visit 3 / Up to 14 Days	≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.

Secondary Outcome Measures

Name	Time	Method
Quality of erection	Visit 3 / Up to 14 days	Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.

Trial Locations

Locations (1)

Warner Chilcott Investigational Study Site; 🇺🇸 Purchase, New York, United States