Clinical trial NCT00790751: Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED
Official title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil (TA-1790) in Subjects With Generalized Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: ED
Erectile Dysfunction
Dysfunction
Erectile
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 646
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to placebo in men with mild to severe erectile dysfunction.


Eligibility criteria: Inclusion Criteria:

* Male subjects, age ≥ 18 years;
* Minimum 6 month history of mild to severe erectile dysfunction;
* Subject is in a monogamous, heterosexual relationship for at least 3 months;
* Subject agrees to make at least 4 attempts at intercourse per month;
* Subject is willing and able to provide informed consent.

Exclusion Criteria:

* Allergy or hypersensitivity to PDE5 inhibitors;
* History of dose-limiting AEs during therapy with a PDE5 inhibitor or hx of consistent treatment failure with other PDE5 inhibitors for therapy of ED;
* Current or expected use of organic nitrates at any time during the study;
* Previous or current antiandrogen therapy;
* Use of prescription or over-the-counter drugs known to inhibit the activity of CYP3A4 at any time during the study;
* Androgen replacement therapy that has not been stable for at least 3 month;
* Initiation or change in dose of any alpha-blocker within 14 days prior to randomization;
* ED as a result of spinal cord injury or radical prostatectomy;
* Untreated hypogonadism or low serum total testosterone
* History of or predisposition to priapism;
* Any penile implant;
* Elevated PSA, other evidence of prostate cancer, or previous radical prostatectomy;
* History of any malignancy (except basal cell carcinoma or squamous cell carcinoma of the skin successfully treated by curative excision);
* History of type 1 or type 2 diabetes;
* Uncontrolled hypertension;
* Hypotension;
* Orthostatic hypotension;
* Significant cardiovascular disease;
* Abnormal ECG;
* Hepatic or renal impairment;
* Positive STD screen;
* Clinically evident penile lesions, abrasions, or anatomical deformities;
* Urinary tract or bladder infection;
* Use of any treatment for erectile dysfunction other than study drug at any time during the study;
* Participation in another investigational study within 30 days of screening or at any time during this study;
* Previous participation in any other investigational study of avanafil;
* History or current drug, alcohol, or substance abuse;
* 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;
* Partners who are \< 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems or major medical conditions that would limit participation in sexual intercourse;
* Evidence of any other condition by history, physical examination, or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medication, 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 Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse
timeFrame: Baseline, 12 weeks
measure: Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina
timeFrame: Baseline, 12 weeks
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: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Homewood
country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Coral Gables
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Jupiter
country: United States
facility: Research Site
state: Florida
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Madisonville
country: United States
facility: Research Site
state: Kentucky
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Lawrenceville
country: United States
facility: Research Site
state: New Jersey
city: Albany
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Cary
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Harrisburg
country: United States
facility: Research Site
state: North Carolina
city: Hickory
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Salisbury
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Beachwood
country: United States
facility: Research Site
state: Ohio
city: Bala Cynwyd
country: United States
facility: Research Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Research Site
state: Pennsylvania
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Spring
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: San Diego Sexual Medicine
name: Irwin Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldstein I, McCullough AR, Jones LA, Hellstrom WJ, Bowden CH, Didonato K, Trask B, Day WW. A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction. J Sex Med. 2012 Apr;9(4):1122-33. doi: 10.1111/j.1743-6109.2011.02629.x. Epub 2012 Jan 16.