Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction

A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men With Erectile Dysfunction

The objectives of this study are to examine the therapeutic effects of two doses of avanafil after dosing in men with erectile dysfunction

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Placebo; Drug: Avanafil 100 mg; Drug: Avanafil 200 mg

• Study Type: Interventional
• Enrollment (Actual): 440
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jupiter, Florida, United States
  • North Carolina
    • Raleigh, North Carolina, United States
    • Wilmington, North Carolina, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Males ≥ 18 years of age;
• Minimum 6 months of erectile dysfunction;
• In a monogamous, heterosexual relationship for at least 3 months;
• Agree to make at least 4 attempts at intercourse per month;
• Provide written informed consent;
• Agree not to use any other ED treatments for erectile dysfunction;
• Willing and able to comply with all study requirements.

Exclusion Criteria:

• Allergy or hypersensitivity to PDE5 inhibitors;
• History of dose-limiting AEs with a PDE5 inhibitor or discontinued use of a PDE5 inhibitor;

• Concomitant use of one or more of the following medications:

  • Other prescription or OTC drugs known to interfere with metabolism by the CYP 3A4 enzyme;
  • Dose of an alpha blocker that has not been stable for at least 14 days;
  • Any nitrate;
• ED as a consequence of advanced neurologic disease, spinal cord injury,or radical prostatectomy;
• Myocardial infarction, stroke, life-threatening arrhythmia or coronary revascularization within the past 6 months;
• Unstable angina, angina with sexual intercourse, or congestive heart failure > NYHA Class II;
• Poorly controlled type 1 or type 2 diabetes;
• Evidence of prostate cancer or previous radical prostatectomy;
• Untreated hypogonadism or total testosterone levels outside normal reference range;
• Abnormal laboratory value(s) judged to be clinically significant by the investigator;
• Positive urine drug screen;
• History of retinitis pigmentosa, nonarteritic anterior ischemic optic neuropathy or glaucoma;
• Previous participation in any other study with avanafil;
• Use of any other investigational medication or device for any indication within 30 days prior to enrollment or at any time during this study;
• Evidence of any clinically significant medical, psychiatric, social or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity or confound the interpretation of study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; One dose 15 minutes before attempting intercourse
Experimental: Avanafil 100 mg	Drug: Avanafil 100 mg; One dose 15 minutes before attempting intercourse
Experimental: Avanafil 200 mg	Drug: Avanafil 200 mg; One dose 15 minutes before attempting intercourse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing	Week 0 (Baseline) up to Week 8 (End of Study)

Collaborators and Investigators

• Sponsor: VIVUS LLC
• Investigators: Study Director: Chuck Bowden, M.D., VIVUS LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: September 25, 2012
• First Submitted That Met QC Criteria: September 28, 2012
• First Posted (Estimate): October 3, 2012

Study Record Updates

• Last Update Posted (Estimate): October 27, 2014
• Last Update Submitted That Met QC Criteria: October 21, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: ED
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: TA-501