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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.

September 25, 2012
October 3, 2012
October 15, 2014
October 27, 2014
October 27, 2014
September 2012
April 2013   (Final data collection date for primary outcome measure)
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) ]
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) ]
Complete list of historical versions of study NCT01698684 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Erectile Dysfunction
  • Drug: Placebo
    One dose 15 minutes before attempting intercourse
  • Drug: Avanafil 100 mg
    One dose 15 minutes before attempting intercourse
  • Drug: Avanafil 200 mg
    One dose 15 minutes before attempting intercourse
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Avanafil 100 mg
    Intervention: Drug: Avanafil 100 mg
  • Experimental: Avanafil 200 mg
    Intervention: Drug: Avanafil 200 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
440
300
April 2013
April 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01698684
TA-501
No
Not Provided
Not Provided
VIVUS, Inc.
VIVUS, Inc.
Not Provided
Study Director: Chuck Bowden, M.D. VIVUS, Inc.
VIVUS, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP