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

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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WC3036-11F/Alprostadil in Vehicle 2.5%

Treatment A

Group Type ACTIVE_COMPARATOR

WC3036-11F/Alprostadil in Vehicle 2.5%

Intervention Type DRUG

330 mcg alprostadil in 2.5% vehicle

WC3036-12F/Alprostadil in Vehicle 0.5%

Treatment B

Group Type EXPERIMENTAL

WC3036-12F/Alprostadil in Vehicle 0.5%

Intervention Type DRUG

330 mcg alprostadil in 0.5% vehicle

WC3036-13P/Vehicle Only 0.5%

Treatment C

Group Type PLACEBO_COMPARATOR

WC3036-13P/Vehicle Only 0.5%

Intervention Type DRUG

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

Intervention Type DRUG

WC3036-12F/Alprostadil in Vehicle 0.5%

330 mcg alprostadil in 0.5% vehicle

Intervention Type DRUG

WC3036-13P/Vehicle Only 0.5%

100 mg cream vehicle 0.5%.

Intervention Type DRUG

Other Intervention Names

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11F 12F Vehicle

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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PR-13311

Identifier Type: -

Identifier Source: org_study_id

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