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

This study has been terminated.
(Re-assessment of study)
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01810575
First received: February 27, 2013
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Drug: WC3036-11F/Alprostadil in Vehicle 2.5%
Drug: WC3036-12F/Alprostadil in Vehicle 0.5%
Drug: WC3036-13P/Vehicle Only 0.5%
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Penile rigidity [ Time Frame: Visit 1 / Up to 5 days ± 3 days ] [ Designated as safety issue: No ]
    ≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.

  • Penile rigidity [ Time Frame: Visit 2 / Up to 9 days ± 3 days ] [ Designated as safety issue: No ]
    ≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.

  • Penile rigidity [ Time Frame: Visit 3 / Up to 14 Days ] [ Designated as safety issue: No ]
    ≥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 Outcome Measures:
  • Quality of erection [ Time Frame: Visit 1 / Up to 5 days ± 3 days ] [ Designated as safety issue: No ]
    Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.

  • Quality of erection [ Time Frame: Visit 2 / Up to 9 days ± 3 days ] [ Designated as safety issue: No ]
    Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.

  • Quality of erection [ Time Frame: Visit 3 / Up to 14 days ] [ Designated as safety issue: No ]
    Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.


Enrollment: 16
Study Start Date: February 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: WC3036-11F/Alprostadil in Vehicle 2.5%
Treatment A
Drug: WC3036-11F/Alprostadil in Vehicle 2.5%
330 mcg alprostadil in 2.5% vehicle
Other Name: 11F
Experimental: WC3036-12F/Alprostadil in Vehicle 0.5%
Treatment B
Drug: WC3036-12F/Alprostadil in Vehicle 0.5%
330 mcg alprostadil in 0.5% vehicle
Other Name: 12F
Placebo Comparator: WC3036-13P/Vehicle Only 0.5%
Treatment C
Drug: WC3036-13P/Vehicle Only 0.5%
100 mg cream vehicle 0.5%.
Other Name: Vehicle

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810575

Locations
United States, New York
Warner Chilcott Investigational Study Site
Purchase, New York, United States, 10755
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Vilma Sniukiene, MD Warner Chilcott
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01810575     History of Changes
Other Study ID Numbers: PR-13311
Study First Received: February 27, 2013
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual and Gender Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Alprostadil
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 29, 2014