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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00790751
First received: November 10, 2008
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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: 646
Study Start Date: November 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (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 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790751

  Show 41 Study Locations
Sponsors and Collaborators
VIVUS, Inc.
Investigators
Principal Investigator: Irwin Goldstein, MD San Diego Sexual Medicine
  More Information

Publications:
Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00790751     History of Changes
Other Study ID Numbers: TA-301
Study First Received: November 10, 2008
Results First Received: May 25, 2012
Last Updated: June 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
ED
Erectile Dysfunction
Dysfunction
Erectile

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

ClinicalTrials.gov processed this record on November 23, 2014