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

This study has been completed.
Information provided by (Responsible Party):
VIVUS, Inc. Identifier:
First received: December 15, 2008
Last updated: August 10, 2012
Last verified: August 2012
This study is being conducted to compare the safety and efficacy of 2 doses of avanafil to placebo in diabetic men with mild to severe erectile dysfunction.

Condition Intervention Phase
Erectile Dysfunction
Drug: placebo
Drug: avanafil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil (TA-1790) in the Treatment of Erectile Dysfunction in Diabetic Men

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 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?"

  • 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?"

  • 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.

Enrollment: 390
Study Start Date: December 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

Inclusion Criteria:

  • Male subjects, age ≥ 18 years;
  • Minimum 6 month history of mild to severe erectile dysfunction;
  • Have documented diabetes (type 1 or type 2);
  • 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);
  • Uncontrolled 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00809471

  Show 39 Study Locations
Sponsors and Collaborators
Principal Investigator: Irwin Goldstein, MD San Diego Sexual Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: VIVUS, Inc. Identifier: NCT00809471     History of Changes
Other Study ID Numbers: TA-302
Study First Received: December 15, 2008
Results First Received: May 25, 2012
Last Updated: August 10, 2012

Keywords provided by VIVUS, Inc.:
Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders processed this record on May 25, 2017