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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00809471
First received: December 15, 2008
Last updated: August 10, 2012
Last verified: August 2012

December 15, 2008
August 10, 2012
December 2008
February 2010   (final data collection date for primary outcome measure)
  • 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.
  • The change in percent of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse. [ Time Frame: Between the run-in period and the 12-week treatment period ] [ Designated as safety issue: No ]
  • The change in percent of sexual attempts in which subjects are able to insert the penis into the partner's vagina between the run-in period. [ Time Frame: Between the run-in period and the 12-week treatment period ] [ Designated as safety issue: No ]
  • The change in score on the erectile function (EF) domain of the IIEF questionnaire from baseline. [ Time Frame: From baseline (visit 2) to end of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00809471 on ClinicalTrials.gov Archive Site
Not Provided
  • The change in response to individual questions and for other domains (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction) from the IIEF between screening. [ Time Frame: Between screening and weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Responses to secondary subject diary questions; [ Time Frame: Between the run-in period and week 12 ] [ Designated as safety issue: No ]
  • The response to the Global Assessment Question on treatment effect and the Future Use Question. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Erectile Dysfunction
  • Drug: placebo
    30 minutes orally prior to initiation of sexual activity
  • Drug: avanafil
    30 minutes orally prior to initiation of sexual activity
    Other Names:
    • TA-1790
    • Stendra
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: avanafil 100 mg
    Intervention: Drug: avanafil
  • Experimental: avanafil 200 mg
    Intervention: Drug: avanafil
Goldstein I, Jones LA, Belkoff LH, Karlin GS, Bowden CH, Peterson CA, Trask BA, Day WW. Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes mellitus. Mayo Clin Proc. 2012 Sep;87(9):843-52. doi: 10.1016/j.mayocp.2012.06.016. Epub 2012 Aug 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
390
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00809471
TA-302
No
VIVUS, Inc.
VIVUS, Inc.
Not Provided
Principal Investigator: Irwin Goldstein, MD San Diego Sexual Medicine
VIVUS, Inc.
August 2012

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