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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01810575
• Other study ID #: PR-13311
• Status: Terminated
• Phase: Phase 2
• First received: February 27, 2013
• Last updated: August 8, 2014
• Start date: February 2013
• Est. completion date: April 2013

Study information

• Verified date: August 2014
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• WC3036-11F/Alprostadil in Vehicle 2.5%
330 mcg alprostadil in 2.5% vehicle
• WC3036-12F/Alprostadil in Vehicle 0.5%
330 mcg alprostadil in 0.5% vehicle
• WC3036-13P/Vehicle Only 0.5%
100 mg cream vehicle 0.5%.

Locations

Country	Name	City	State
United States	Warner Chilcott Investigational Study Site	Purchase	New York

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Quality of erection	Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.	Visit 1 / Up to 5 days ± 3 days	No
Secondary	Quality of erection	Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.	Visit 2 / Up to 9 days ± 3 days	No
Secondary	Quality of erection	Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.	Visit 3 / Up to 14 days	No