Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00895011
First received: May 5, 2009
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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.


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, Parallel Group, Multicenter Study of the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy

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 Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse [ Time Frame: Baseline, Week 12 ] [ 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?"

  • The Change in Percentage of Sexual Attempts in Which Subjects Are Able to Insert the Penis Into the Partner's Vagina [ Time Frame: Baseline, Week 12 ] [ 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 scores from questions 1-5 & 15 range from 1 to 30. A higher score indicates better erectile function.


Enrollment: 298
Study Start Date: April 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
One dose 30 minutes prior to initiation of sexual activity
Experimental: Avanafil 100 mg Drug: Avanafil
One dose 30 minutes prior to initiation of sexual activity
Other Names:
  • TA-1790
  • Stendra
Experimental: Avanafil 200 mg Drug: Avanafil
One dose 30 minutes prior to initiation of sexual activity
Other Names:
  • TA-1790
  • Stendra

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria

  • 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;
  • Unstable angina, angina with sexual intercourse, or congestive heart failure > NYHA Class II;
  • History or ECG evidence of any high-risk arrhythmia or clinically significant ECG;
  • Hypertrophic, obstructive, or other clinically significant cardiomyopathy, moderate or severe cardiac valvular disease;
  • Type 1 or type 2 diabetes, history of use of any antidiabetic medication;
  • Clinically evident penile lesions, abrasions, anatomical deformities such as penile fibrosis, Peyronie's disease, penile implants, urinary tract or bladder infection, or sexually transmissible disease that the investigator deems to be clinically significant;
  • Condition(s) predisposing to priapism, such as sickle cell disease , multiple myeloma, or leukemia;
  • Any malignancy other than carcinoma of the prostate (except basal cell carcinoma or squamous cell carcinoma of the skin);
  • Prior use of, or likely to require radiotherapy, chemotherapy, androgen deprivation therapy, cryotherapy, non-nerve-sparing surgery, and/or bladder or penile surgery during the study;
  • Evidence of significant hepatic impairment;
  • On dialysis, or history of renal transplantation;
  • Untreated hypogonadism or low serum total testosterone;
  • Abnormal laboratory value(s) judged to be clinically significant by the investigator;
  • Positive STD screen (syphilis, gonorrhea, or chlamydia);
  • Positive for HIV, HCV Ab, or HBsAg at screening;
  • History or current drug, alcohol, or substance abuse;
  • Positive urine drug screen;
  • Positive breath alcohol test;
  • Retinitis pigmentosa or nonarteritic anterior ischemic optic neuropathy;
  • Use of any treatment or device for treatment of erectile dysfunction;
  • Use of any other investigational medication or device for any indication within 30 days prior to enrollment or at any time during this study;
  • Previous participation in any other investigational study of avanafil;
  • 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;
  • Involvement in the planning and conduct of the study on the part of subject or partner;
  • Evidence of any clinically significant medical, psychiatric, social or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, 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: NCT00895011

  Hide Study Locations
Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85050
United States, California
Research Site
Laguna Hills, California, United States, 92653
Research Site
Los Angeles, California, United States, 90095
Research Site
Los Angeles, California, United States, 90073
Research Site
Sacramento, California, United States, 95817
United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
Research Site
Englewood, Colorado, United States, 80113
Research Site
Parker, Colorado, United States, 80134
United States, District of Columbia
Research Site
Washington, District of Columbia, United States, 20006
United States, Florida
Research Site
Jacksonville, Florida, United States, 32224
Research Site
Miami, Florida, United States, 33136
Research Site
Trinity, Florida, United States, 34655
United States, Illinois
Research Site
Chicago, Illinois, United States, 60611
Research Site
Chicago, Illinois, United States, 60637
Research Site
Springfield, Illinois, United States, 62703
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Research Site
New Orleans, Louisiana, United States, 70112
Research Site
Shreveport, Louisiana, United States, 71106
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21287
Research Site
Towson, Maryland, United States, 21204
United States, Massachusetts
Research Site
Brighton, Massachusetts, United States, 02135
Research Site
Burlington, Massachusetts, United States, 01805
Research Site
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Research Site
Hackensack, New Jersey, United States, 07601
Research Site
Lawrenceville, New Jersey, United States, 08648
United States, New York
Research Site
Brooklyn, New York, United States, 11235
Research Site
Brooklyn, New York, United States, 11215
Research Site
Garden City, New York, United States, 11530
Research Site
Great Neck, New York, United States, 11021
Research Site
New York, New York, United States, 10029
Research Site
New York, New York, United States, 10065
Research Site
New York, New York, United States, 10016
Research Site
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27710
Research Site
Greensboro, North Carolina, United States, 27403
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45212
Research Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Research Site
Bala Cynwyd, Pennsylvania, United States, 19004
Research Site
Philadelphia, Pennsylvania, United States, 19111
Research Site
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Research Site
Myrtle Beach, South Carolina, United States, 29572
Research Site
Rock Hill, South Carolina, United States, 29732
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37232
United States, Texas
Research Site
Arlington, Texas, United States, 76017
Research Site
Houston, Texas, United States, 77030
Research Site
San Antonio, Texas, United States, 78229
Research Site
Temple, Texas, United States, 76508
United States, Virginia
Research Site
Charlottesville,, Virginia, United States, 22908
Research Site
Fairfax, Virginia, United States, 22030
Research Site
Richmond, Virginia, United States, 23235
Sponsors and Collaborators
VIVUS, Inc.
Investigators
Study Director: John Mulhall, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided by VIVUS, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00895011     History of Changes
Obsolete Identifiers: NCT01171001
Other Study ID Numbers: TA-303
Study First Received: May 5, 2009
Results First Received: May 25, 2012
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
Erectile Dysfunction
E.D.

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

ClinicalTrials.gov processed this record on July 26, 2014