Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698684
• Other study ID #: TA-501
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2012
• Last updated: October 21, 2014
• Start date: September 2012
• Est. completion date: April 2013

Study information

• Verified date: October 2014
• Source: VIVUS, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Placebo
One dose 15 minutes before attempting intercourse
• Avanafil 100 mg
One dose 15 minutes before attempting intercourse
• Avanafil 200 mg
One dose 15 minutes before attempting intercourse

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VIVUS, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No