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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

Phase 3
18 Years
70 Years
Not Enrolling
Erectile Dysfunction

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Trial Information

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

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

- 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

- 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

- 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

- 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse

Outcome Description:

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?"

Outcome Time Frame:

Baseline, Week 12

Safety Issue:


Principal Investigator

John Mulhall, MD

Investigator Role:

Study Director

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

April 2011

Related Keywords:

  • Erectile Dysfunction
  • Erectile Dysfunction
  • E.D.
  • Erectile Dysfunction



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