Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy
1 other identifier
interventional
298
1 country
51
Brief Summary
The objectives of this study are to evaluate the safety and efficacy of two doses of avanafil in the treatment of adult males for erectile dysfunction following bilateral nerve-sparing radical prostatectomy.
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 Apr 2009
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 5, 2009
CompletedFirst Posted
Study publicly available on registry
May 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
June 28, 2012
CompletedOctober 1, 2012
September 1, 2012
2 years
May 5, 2009
May 25, 2012
September 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Percentage of Sexual Attempts in Which Subjects Are 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, Week 12
The Change in Percentage of Sexual Attempts in Which Subjects Are 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, Week 12
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 scores from questions 1-5 \& 15 range 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:
- Adult males ≥ 18 years and ≤ 70 years;
- Have a history of erectile dysfunction of at least 6 months duration following bilateral nerve-sparing retropubic radical prostatectomy;
- Have a PSA level consistent with the absence of prostate cancer;
- Have a history of sexual potency prior to radical prostatectomy without requiring medical therapy;
- Be in a monogamous, heterosexual relationship with their current partner for at least 3 months;
- Provide written informed consent;
- Agree to make at least 4 attempts at intercourse per month;
- Agree not to use any other treatments for erectile dysfunction;
- Be willing and able to comply with all study requirements (including scheduled study visits, treatment plans, laboratory tests and other study procedures).
You may not qualify if:
- Allergy or hypersensitivity to PDE5 inhibitors or any of the components of these drug products;
- History of dose-limiting AEs during prior treatment with a PDE5 inhibitor or discontinued use of a PDE5 inhibitor due to lack of efficacy at the highest tolerated dose;
- Concomitant use of one or more of the following medications:
- Any nitrate, trazodone, itraconazole, ketoconazole, erythromycin, or cimetidine;
- Other prescription or OTC drugs that are known to interfere with metabolism by the CYP 3A4 enzyme;
- If receiving hormone replacement therapy (including thyroid supplementation), dose that has not been stable for at least 3 months;
- If treated with an alpha blocker, dose that has not been stable for at least 14 days;
- Erectile dysfunction as a consequence of advanced neurologic disease, spinal cord injury, or diabetes;
- History of severe erectile dysfunction requiring medical therapy prior to bilateral nerve-sparing radical prostatectomy;
- History of previous pelvic surgery, brachytherapy, or cryotherapy of the prostate;
- Sexual partner who is under 18 years of age, pregnant, intends to become pregnant during the course of the study, is breastfeeding, has dyspareunia or other gynecologic conditions or other major medical conditions that would interfere with sexual activity or would have difficulty complying with study requirements;
- Uncontrolled hypertension;
- Hypotension;
- Orthostatic hypotension;
- Myocardial infarction, stroke, life-threatening arrhythmia or coronary revascularization within the past 6 months;
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VIVUS LLClead
Study Sites (51)
Research Site
Phoenix, Arizona, 85050, United States
Research Site
Laguna Hills, California, 92653, United States
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Los Angeles, California, 90073, United States
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Los Angeles, California, 90095, United States
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Sacramento, California, 95817, United States
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Aurora, Colorado, 80045, United States
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Englewood, Colorado, 80113, United States
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Parker, Colorado, 80134, United States
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Washington D.C., District of Columbia, 20006, United States
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Jacksonville, Florida, 32224, United States
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Miami, Florida, 33136, United States
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Trinity, Florida, 34655, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60637, United States
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Springfield, Illinois, 62703, United States
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Indianapolis, Indiana, 46202, United States
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New Orleans, Louisiana, 70112, United States
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Shreveport, Louisiana, 71106, United States
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Baltimore, Maryland, 21287, United States
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Towson, Maryland, 21204, United States
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Brighton, Massachusetts, 02135, United States
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Burlington, Massachusetts, 01805, United States
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Jamaica Plain, Massachusetts, 02130, United States
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Ann Arbor, Michigan, 48109, United States
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Hackensack, New Jersey, 07601, United States
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Lawrenceville, New Jersey, 08648, United States
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Brooklyn, New York, 11215, United States
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Brooklyn, New York, 11235, United States
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Garden City, New York, 11530, United States
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Great Neck, New York, 11021, United States
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New York, New York, 10016, United States
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New York, New York, 10029, United States
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New York, New York, 10065, United States
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Poughkeepsie, New York, 12601, United States
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Durham, North Carolina, 27710, United States
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Greensboro, North Carolina, 27403, United States
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Cincinnati, Ohio, 45212, United States
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Cleveland, Ohio, 44195, United States
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Bala-Cynwyd, Pennsylvania, 19004, United States
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Philadelphia, Pennsylvania, 19107, United States
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Philadelphia, Pennsylvania, 19111, United States
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Myrtle Beach, South Carolina, 29572, United States
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Rock Hill, South Carolina, 29732, United States
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Nashville, Tennessee, 37232, United States
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Arlington, Texas, 76017, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78229, United States
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Temple, Texas, 76508, United States
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Charlottesville, Virginia, 22908, United States
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Fairfax, Virginia, 22030, United States
Research Site
Richmond, Virginia, 23235, United States
Related Publications (1)
Mulhall JP, Burnett AL, Wang R, McVary KT, Moul JW, Bowden CH, DiDonato K, Shih W, Day WW. A phase 3, placebo controlled study of the safety and efficacy of avanafil for the treatment of erectile dysfunction after nerve sparing radical prostatectomy. J Urol. 2013 Jun;189(6):2229-36. doi: 10.1016/j.juro.2012.11.177. Epub 2012 Dec 3.
PMID: 23219537DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wesley W Day, PhD
- Organization
- Vivus, Inc.
Study Officials
- STUDY DIRECTOR
John Mulhall, MD
Memorial Sloan Kettering Cancer Center
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
May 5, 2009
First Posted
May 7, 2009
Study Start
April 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
October 1, 2012
Results First Posted
June 28, 2012
Record last verified: 2012-09