Research Evaluating an Investigational Medication for Erectile Dysfunction - Diabetic ED (REVIVE-D)
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
1 other identifier
interventional
390
1 country
39
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2008
Shorter than P25 for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 15, 2008
CompletedFirst Posted
Study publicly available on registry
December 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
June 28, 2012
CompletedAugust 17, 2012
August 1, 2012
1.2 years
December 15, 2008
May 25, 2012
August 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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)
Study Arms (3)
placebo
PLACEBO COMPARATORavanafil 100 mg
EXPERIMENTALavanafil 200 mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VIVUS LLClead
Study Sites (39)
Research Site
Birmingham, Alabama, 35209, United States
Research Site
Homewood, Alabama, 35209, United States
Research Site
Tucson, Arizona, 85712, United States
Research Site
Sacramento, California, 95821, United States
Research Site
San Diego, California, 92120, United States
Research Site
San Diego, California, 92123, United States
Research Site
Waterbury, Connecticut, 06708, United States
Research Site
Clearwater, Florida, 33756, United States
Research Site
Clearwater, Florida, 33761, United States
Research Site
Coral Gables, Florida, 33134, United States
Research Site
Hialeah, Florida, 33012, United States
Research Site
Jacksonville, Florida, 32205, United States
Research Site
Jacksonville, Florida, 32259, United States
Research Site
Jupiter, Florida, 33458, United States
Research Site
Ocala, Florida, 34471, United States
Research Site
Pembroke Pines, Florida, 33024, United States
Research Site
Tampa, Florida, 33624, United States
Research Site
Atlanta, Georgia, 30328, United States
Research Site
Wichita, Kansas, 67205, United States
Research Site
Madisonville, Kentucky, 42431, United States
Research Site
Shreveport, Louisiana, 71106, United States
Research Site
Kansas City, Missouri, 64114, United States
Research Site
Lawrenceville, New Jersey, 08648, United States
Research Site
Albany, New York, 12206, United States
Research Site
Cary, North Carolina, 27518, United States
Research Site
Charlotte, North Carolina, 28207, United States
Research Site
Charlotte, North Carolina, 2829, United States
Research Site
Harrisburg, North Carolina, 28075, United States
Research Site
Raleigh, North Carolina, 27609, United States
Research Site
Salisbury, North Carolina, 28144, United States
Research Site
Wilmington, North Carolina, 28401, United States
Research Site
Winston-Salem, North Carolina, 27103, United States
Research Site
Beachwood, Ohio, 44122, United States
Research Site
Bala-Cynwyd, Pennsylvania, 19004, United States
Research Site
Lancaster, Pennsylvania, 17601, United States
Research Site
El Paso, Texas, 79935, United States
Research Site
Houston, Texas, 77074, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Spring, Texas, 77386, United States
Related Publications (1)
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.
PMID: 22857780DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wesley W Day PhD
- Organization
- Vivus, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Irwin Goldstein, MD
San Diego Sexual Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2008
First Posted
December 17, 2008
Study Start
December 1, 2008
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
August 17, 2012
Results First Posted
June 28, 2012
Record last verified: 2012-08