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

NCT01810575 | Terminated Phase 2

• 1 other identifier: PR-13311
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (3)

• Penile rigidity

  ≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.

  Visit 1 / Up to 5 days ± 3 days

• Penile rigidity

  ≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.

  Visit 2 / Up to 9 days ± 3 days

• Penile rigidity

  ≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.

  Visit 3 / Up to 14 Days

Secondary Outcomes (3)

• Quality of erection

  Visit 1 / Up to 5 days ± 3 days

• Quality of erection

  Visit 2 / Up to 9 days ± 3 days

• Quality of erection

  Visit 3 / Up to 14 days

Study Arms (3)

WC3036-11F/Alprostadil in Vehicle 2.5%

ACTIVE COMPARATOR

Treatment A

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

WC3036-12F/Alprostadil in Vehicle 0.5%

EXPERIMENTAL

Treatment B

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

WC3036-13P/Vehicle Only 0.5%

PLACEBO COMPARATOR

Treatment C

Drug: WC3036-13P/Vehicle Only 0.5%

Interventions

WC3036-11F/Alprostadil in Vehicle 2.5% DRUG

330 mcg alprostadil in 2.5% vehicle

Also known as: 11F

WC3036-11F/Alprostadil in Vehicle 2.5%

WC3036-12F/Alprostadil in Vehicle 0.5% DRUG

330 mcg alprostadil in 0.5% vehicle

Also known as: 12F

WC3036-12F/Alprostadil in Vehicle 0.5%

WC3036-13P/Vehicle Only 0.5% DRUG

100 mg cream vehicle 0.5%.

Also known as: Vehicle

WC3036-13P/Vehicle Only 0.5%

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Warner Chilcott: lead

Study Sites (1)

Warner Chilcott Investigational Study Site

Purchase, New York, 10755, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Vilma Sniukiene, MD

  Warner Chilcott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 13, 2013
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 12, 2014

Record last verified: 2014-08

Locations

US (1)