Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED (REVIVE)

June 27, 2012 updated by: VIVUS LLC

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil (TA-1790) in Subjects With Generalized Erectile Dysfunction

This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to placebo in men with mild to severe erectile dysfunction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

646

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Research Site
      • Homewood, Alabama, United States, 35209
        • Research Site
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Research Site
    • California
      • Sacramento, California, United States, 95821
        • Research Site
      • San Diego, California, United States, 92120
        • Research Site
      • San Diego, California, United States, 92123
        • Research Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Research Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Research Site
      • Clearwater, Florida, United States, 33761
        • Research Site
      • Coral Gables, Florida, United States, 33134
        • Research Site
      • Hialeah, Florida, United States, 33012
        • Research Site
      • Jacksonville, Florida, United States, 32205
        • Research Site
      • Jacksonville, Florida, United States, 32259
        • Research Site
      • Jupiter, Florida, United States, 33458
        • Research Site
      • Ocala, Florida, United States, 34471
        • Research Site
      • Pembroke Pines, Florida, United States, 33024
        • Research Site
      • Tampa, Florida, United States, 33624
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Research Site
      • Atlanta, Georgia, United States, 30308
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Research Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Research Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Research Site
    • New York
      • Albany, New York, United States, 12206
        • Research Site
      • New York, New York, United States, 10016
        • Research Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Research Site
      • Charlotte, North Carolina, United States, 28207
        • Research Site
      • Charlotte, North Carolina, United States, 28209
        • Research Site
      • Harrisburg, North Carolina, United States, 28075
        • Research Site
      • Hickory, North Carolina, United States, 28601
        • Research Site
      • Raleigh, North Carolina, United States, 27609
        • Research Site
      • Salisbury, North Carolina, United States, 28144
        • Research Site
      • Wilmington, North Carolina, United States, 28401
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Research Site
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Research Site
      • Lancaster, Pennsylvania, United States, 17601
        • Research Site
    • Texas
      • El Paso, Texas, United States, 79925
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • Spring, Texas, United States, 77386
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male subjects, age ≥ 18 years;
  • Minimum 6 month history of mild to severe erectile dysfunction;
  • Subject is in a monogamous, heterosexual relationship for at least 3 months;
  • Subject agrees to make at least 4 attempts at intercourse per month;
  • Subject is willing and able to provide informed consent.

Exclusion Criteria:

  • Allergy or hypersensitivity to PDE5 inhibitors;
  • History of dose-limiting AEs during therapy with a PDE5 inhibitor or hx of consistent treatment failure with other PDE5 inhibitors for therapy of ED;
  • Current or expected use of organic nitrates at any time during the study;
  • Previous or current antiandrogen therapy;
  • Use of prescription or over-the-counter drugs known to inhibit the activity of CYP3A4 at any time during the study;
  • Androgen replacement therapy that has not been stable for at least 3 month;
  • Initiation or change in dose of any alpha-blocker within 14 days prior to randomization;
  • ED as a result of spinal cord injury or radical prostatectomy;
  • Untreated hypogonadism or low serum total testosterone
  • History of or predisposition to priapism;
  • Any penile implant;
  • Elevated PSA, other evidence of prostate cancer, or previous radical prostatectomy;
  • History of any malignancy (except basal cell carcinoma or squamous cell carcinoma of the skin successfully treated by curative excision);
  • History of type 1 or type 2 diabetes;
  • Uncontrolled hypertension;
  • Hypotension;
  • Orthostatic hypotension;
  • Significant cardiovascular disease;
  • Abnormal ECG;
  • Hepatic or renal impairment;
  • Positive STD screen;
  • Clinically evident penile lesions, abrasions, or anatomical deformities;
  • Urinary tract or bladder infection;
  • Use of any treatment for erectile dysfunction other than study drug at any time during the study;
  • Participation in another investigational study within 30 days of screening or at any time during this study;
  • Previous participation in any other investigational study of avanafil;
  • History or current drug, alcohol, or substance abuse;
  • Any history of bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity or antidepressant use that has not been stable for at least 3 months;
  • Partners who are < 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems or major medical conditions that would limit participation in sexual intercourse;
  • Evidence of any other condition by history, physical examination, or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity, or confound the interpretation of study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
30 minutes orally prior to initiation of sexual activity
Experimental: avanafil 100 mg
Drug: avanafil
30 minutes orally prior to initiation of sexual activity
Other Names:
  • TA-1790
  • Stendra
Experimental: avanafil 200 mg
Drug: avanafil
30 minutes orally prior to initiation of sexual activity
Other Names:
  • TA-1790
  • Stendra
Experimental: avanafil 50 mg
Drug: avanafil
30 minutes orally prior to initiation of sexual activity
Other Names:
  • TA-1790
  • Stendra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score
Time Frame: Baseline, End of Treatment (up to 12 weeks)
Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function.
Baseline, End of Treatment (up to 12 weeks)
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse
Time Frame: Baseline, 12 weeks
Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?"
Baseline, 12 weeks
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina
Time Frame: Baseline, 12 weeks
Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 "Were you able to insert your penis into your partner's vagina?"
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIVUS LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Estimate)

July 11, 2012

Last Update Submitted That Met QC Criteria

June 27, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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