Clinical trial NCT00895011: Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
E.D.
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 298
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse
timeFrame: Baseline, Week 12
measure: The Change in Percentage of Sexual Attempts in Which Subjects Are Able to Insert the Penis Into the Partner's Vagina
timeFrame: Baseline, Week 12
measure: Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score
timeFrame: Baseline, End of Treatment (up to 12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Laguna Hills
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Englewood
country: United States
facility: Research Site
state: Colorado
city: Parker
country: United States
facility: Research Site
state: Colorado
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Trinity
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Springfield
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Towson
country: United States
facility: Research Site
state: Maryland
city: Brighton
country: United States
facility: Research Site
state: Massachusetts
city: Burlington
country: United States
facility: Research Site
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Hackensack
country: United States
facility: Research Site
state: New Jersey
city: Lawrenceville
country: United States
facility: Research Site
state: New Jersey
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Garden City
country: United States
facility: Research Site
state: New York
city: Great Neck
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Poughkeepsie
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Bala Cynwyd
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Research Site
state: South Carolina
city: Rock Hill
country: United States
facility: Research Site
state: South Carolina
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Arlington
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Temple
country: United States
facility: Research Site
state: Texas
city: Charlottesville,
country: United States
facility: Research Site
state: Virginia
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: John Mulhall, MD
role: STUDY_DIRECTOR
References:
citation: 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.