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

Warner Chilcott

Status and phase: Terminated; Phase 2

Conditions: Erectile Dysfunction

Treatments: Drug: WC3036-12F/Alprostadil in Vehicle 0.5%; Drug: WC3036-13P/Vehicle Only 0.5%; Drug: WC3036-11F/Alprostadil in Vehicle 2.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01810575

PR-13311

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 3 patient groups, including a placebo group

WC3036-11F/Alprostadil in Vehicle 2.5%

Active Comparator group

Description:

Treatment A

Treatment:

Drug: WC3036-11F/Alprostadil in Vehicle 2.5%

WC3036-12F/Alprostadil in Vehicle 0.5%

Experimental group

Description:

Treatment B

Treatment:

Drug: WC3036-12F/Alprostadil in Vehicle 0.5%

WC3036-13P/Vehicle Only 0.5%

Placebo Comparator group

Description:

Treatment C

Treatment:

Drug: WC3036-13P/Vehicle Only 0.5%