Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction

Phase 4

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Placebo; Drug: Avanafil 100 mg; Drug: Avanafil 200 mg

• Registration Number: NCT01698684
• Lead Sponsor: VIVUS LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Disposition First Submitted: 2014-01-13
• Disposition First Submitted QC: 2014-01-13
• Disposition First Posted: 2014-02-10
• Status Verified: 2014-10
• Results First Submitted: 2014-10-15
• Results First Submitted QC: 2014-10-21
• Last Update Submitted: 2014-10-21
• Results First Posted: 2014-10-27
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 440

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Avanafil 100 mg	Avanafil 100 mg	-
Avanafil 200 mg	Avanafil 200 mg	-

Primary Outcome Measures

Name	Time	Method
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)