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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00790751
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : June 28, 2012
Last Update Posted : July 11, 2012
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: placebo Drug: avanafil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 646 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil (TA-1790) in Subjects With Generalized Erectile Dysfunction
Study Start Date : November 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Avanafil

Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo
30 minutes orally prior to initiation of sexual activity

Experimental: avanafil 50 mg Drug: avanafil
30 minutes orally prior to initiation of sexual activity
Other Names:
  • TA-1790
  • Stendra

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




Primary Outcome Measures :
  1. 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?"

  2. 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?"

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT00790751


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35209
Research Site
Homewood, Alabama, United States, 35209
United States, Arizona
Research Site
Tucson, Arizona, United States, 85712
United States, California
Research Site
Sacramento, California, United States, 95821
Research Site
San Diego, California, United States, 92120
Research Site
San Diego, California, United States, 92123
United States, Connecticut
Research Site
Waterbury, Connecticut, United States, 06708
United States, Florida
Research Site
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
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30308
Research Site
Atlanta, Georgia, United States, 30328
United States, Kansas
Research Site
Wichita, Kansas, United States, 67205
United States, Kentucky
Research Site
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Research Site
Shreveport, Louisiana, United States, 71106
United States, Missouri
Research Site
Kansas City, Missouri, United States, 64114
United States, New Jersey
Research Site
Lawrenceville, New Jersey, United States, 08648
United States, New York
Research Site
Albany, New York, United States, 12206
Research Site
New York, New York, United States, 10016
United States, North Carolina
Research Site
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
United States, Ohio
Research Site
Beachwood, Ohio, United States, 44122
United States, Pennsylvania
Research Site
Bala Cynwyd, Pennsylvania, United States, 19004
Research Site
Lancaster, Pennsylvania, United States, 17601
United States, Texas
Research Site
El Paso, Texas, United States, 79925
Research Site
Houston, Texas, United States, 77074
Research Site
Spring, Texas, United States, 77386
Sponsors and Collaborators
VIVUS, Inc.
Investigators
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Principal Investigator: Irwin Goldstein, MD San Diego Sexual Medicine
Publications of Results:
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Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00790751    
Other Study ID Numbers: TA-301
First Posted: November 13, 2008    Key Record Dates
Results First Posted: June 28, 2012
Last Update Posted: July 11, 2012
Last Verified: June 2012
Keywords provided by VIVUS, Inc.:
ED
Erectile Dysfunction
Dysfunction
Erectile
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders