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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01810575

Enrollment

Registered

2013-03-13

Start date

2013-02-28

Completion date

2013-04-30

Last updated

2014-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

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.

Interventions

DRUGWC3036-11F/Alprostadil in Vehicle 2.5%

330 mcg alprostadil in 2.5% vehicle

DRUGWC3036-12F/Alprostadil in Vehicle 0.5%

330 mcg alprostadil in 0.5% vehicle

DRUGWC3036-13P/Vehicle Only 0.5%

100 mg cream vehicle 0.5%.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Penile rigidity	Visit 1 / Up to 5 days ± 3 days	≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.

Secondary

Measure	Time frame	Description
Quality of erection	Visit 1 / Up to 5 days ± 3 days	Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026