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

Erectile Dysfunction Clinical Trial

— REVIVE-D  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809471
• Other study ID #: TA-302
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2008
• Last updated: August 10, 2012
• Start date: December 2008
• Est. completion date: February 2010

Study information

• Verified date: August 2012
• Source: VIVUS, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• placebo
30 minutes orally prior to initiation of sexual activity
• avanafil
30 minutes orally prior to initiation of sexual activity
• avanafil
30 minutes orally prior to initiation of sexual activity

Locations

Country	Name	City	State
United States	Research Site	Albany	New York
United States	Research Site	Atlanta	Georgia
United States	Research Site	Bala Cynwyd	Pennsylvania
United States	Research Site	Beachwood	Ohio
United States	Research Site	Birmingham	Alabama
United States	Research Site	Cary	North Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Clearwater	Florida
United States	Research Site	Clearwater	Florida
United States	Research Site	Coral Gables	Florida
United States	Research Site	El Paso	Texas
United States	Research Site	Harrisburg	North Carolina
United States	Research Site	Hialeah	Florida
United States	Research Site	Homewood	Alabama
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jupiter	Florida
United States	Research Site	Kansas City	Missouri
United States	Research Site	Lancaster	Pennsylvania
United States	Research Site	Lawrenceville	New Jersey
United States	Research Site	Madisonville	Kentucky
United States	Research Site	Ocala	Florida
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Sacramento	California
United States	Research Site	Salisbury	North Carolina
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	San Diego	California
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Spring	Texas
United States	Research Site	Tampa	Florida
United States	Research Site	Tucson	Arizona
United States	Research Site	Waterbury	Connecticut
United States	Research Site	Wichita	Kansas
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VIVUS, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse	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	No
Primary	Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina	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	No
Primary	Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score	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)	No