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Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT01698684
Recruitment Status : Completed
First Posted : October 3, 2012
Results First Posted : October 27, 2014
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.

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

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Placebo Drug: Avanafil 100 mg Drug: Avanafil 200 mg Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men With Erectile Dysfunction
Study Start Date : September 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Avanafil
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing [ Time Frame: Week 0 (Baseline) up to Week 8 (End of Study) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT01698684     History of Changes
Other Study ID Numbers: TA-501
First Posted: October 3, 2012    Key Record Dates
Results First Posted: October 27, 2014
Last Update Posted: October 27, 2014
Last Verified: October 2014

Keywords provided by VIVUS, Inc.:
ED

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders