Overview

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

Status:
Terminated
Trial end date:
2013-04-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Warner Chilcott
Treatments:
Alprostadil
Criteria
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