Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT01698684
First received: September 25, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Erectile Dysfunction
Drug: Placebo
Drug: Avanafil 100 mg
Drug: Avanafil 200 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men With Erectile Dysfunction

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • Change in percentage of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse [ Time Frame: Week 0 (Baseline), Week 8 (End of Study) ] [ Designated as safety issue: No ]

Enrollment: 440
Study Start Date: September 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698684

Locations
United States, Florida
Jupiter, Florida, United States
United States, North Carolina
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Sponsors and Collaborators
VIVUS, Inc.
Investigators
Study Director: Chuck Bowden, M.D. VIVUS, Inc.
  More Information

No publications provided

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT01698684     History of Changes
Other Study ID Numbers: TA-501
Study First Received: September 25, 2012
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
ED

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014