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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00895011
Recruitment Status : Completed
First Posted : May 7, 2009
Results First Posted : June 28, 2012
Last Update Posted : October 1, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Placebo Drug: Avanafil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Avanafil

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    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?"

  2. 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 ]
    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?"

  3. Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score [ Time Frame: Baseline, End of Treatment (up to 12 weeks) ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00895011

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Sponsors and Collaborators
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Study Director: John Mulhall, MD Memorial Sloan Kettering Cancer Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: VIVUS, Inc. Identifier: NCT00895011    
Obsolete Identifiers: NCT01171001
Other Study ID Numbers: TA-303
First Posted: May 7, 2009    Key Record Dates
Results First Posted: June 28, 2012
Last Update Posted: October 1, 2012
Last Verified: September 2012
Keywords provided by VIVUS, Inc.:
Erectile Dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders