Clinical trial NCT00379756: A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy, Safety, and Duration of Erection of Flexible-dose Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction, impotence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-22
Enrollment: 395
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study consisting of four periods (screening, run-in, treatment, follow-up). A four-week treatment-free, run-in period where the subject will make at least four attempts at intercourse on four separate days with at least 50% of the attempts must be unsuccessful. During run-in the subjects will be using a stopwatch to measure the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina. Next there are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to visit the clinic on 5 occasions over a period of 4 months.


Eligibility criteria: Inclusion criteria:

* Males with ED for more than six months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
* Stable heterosexual relationship for more than 6 months.
* The subject must make at least four attempts at sexual intercourse (according to the question in the subject diary: Was sexual activity initiated with the intention of intercourse?) on four separate days during the untreated baseline period. At least 50% of attempts during this period must be unsuccessful, according to the following questions from the subject diary \[at least one question should be answered "No"\]: Were you able to achieve at least some erection (some enlargement of the penis)? Were you able to insert your penis into your partner's vagina? Did your erection last long enough for you to have successful intercourse?
* Diagnosis of dyslipidemia treated with a stable dose of a statin for 6 months at Visit 1.
* IIEF-EF domain score of 25 denoting mild to severe ED at Visit 2.
* Documented, dated, written Informed Consent.

Exclusion criteria:

* Premature ejaculator \<2 minutes
* Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities, or substance abuse disorder that MD feels subject will not be able to complete the study.
* Low sexual desire.
* Prior prostatectomy surgery
* Severe chronic or acute liver disease, history of moderate or severe liver impairment
* Clinically significant chronic hematological disease
* Bleeding disorder or significant active peptic ulceration.
* Cardiovascular conditions that prevent sexual activity.
* History of heart attack, stroke, or life-threatening arrhythmia within the prior 6 months.
* hypotension or hypertension at rest.
* cancer within the past 5 years. Use of these medications: nitrates or nitric oxide donors, anti-androgens, oral or injectable androgens, received any investigational drug (including placebo) within 30 days of screening (Visit 1).
* Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories.
* Subjects who are taking the following potent inhibitors of cytochrome P-450 3A4.
* Abnormal Laboratory Values:

  1. serum total testosterone level \>25% below the lower limit of normal
  2. serum creatinine \>3.0 mg/dl.
  3. AST and/or ALT \>3x the upper limit of normal.

Primary outcomes:
measure: Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)
timeFrame: Up to Week 12
measure: Mean success rate of insertion based on attempts
timeFrame: Up to Week 12
measure: Mean success rates of maintenance based on attempts
timeFrame: Up to Week 12
Secondary outcomes:
measure: Mean duration of erection leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 [SEP-3]
timeFrame: Up to Week 12
measure: Change from Baseline in scores for questions on the IIEF questionnaire and scores of the other non-EF domains of the IIEF
timeFrame: Up to Week 12
measure: Number of participants with normal erectile function having EF domain scores of 26 and above
timeFrame: Up to Week 12
measure: Change from Baseline in participant's diary results
timeFrame: Up to Week 12
measure: Mean duration of erection regardless of SEP-3 Response
timeFrame: Up to Week 12
measure: Change from Baseline in duration of erection leading to completion of successful intercourse.
timeFrame: Up to Week 12
measure: Number of participants with response 'Yes' for Global Assessment Question
timeFrame: Up to Week 12
measure: Mean score for Keep It Simple (KIS) scale
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: GSK Investigational Site
state: Alabama
city: Homewood
country: United States
facility: GSK Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Concord
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Park
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Modesto
country: United States
facility: GSK Investigational Site
state: California
city: Newport Beach
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facility: GSK Investigational Site
state: California
city: Orangevale
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facility: GSK Investigational Site
state: California
city: Santa Ana
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facility: GSK Investigational Site
state: California
city: Walnut Creek
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facility: GSK Investigational Site
state: California
city: Denver
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facility: GSK Investigational Site
state: Colorado
city: Wheat Ridge
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facility: GSK Investigational Site
state: Colorado
city: New Britain
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facility: GSK Investigational Site
state: Connecticut
city: Aventura
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facility: GSK Investigational Site
state: Florida
city: Clearwater
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facility: GSK Investigational Site
state: Florida
city: Coral Gables
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Myers
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facility: GSK Investigational Site
state: Florida
city: North Miami
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facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Pinecrest
country: United States
facility: GSK Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: GSK Investigational Site
state: Florida
city: Sarasota
country: United States
facility: GSK Investigational Site
state: Florida
city: South Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Columbus
country: United States
facility: GSK Investigational Site
state: Georgia
city: Dawsonville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Roswell
country: United States
facility: GSK Investigational Site
state: Georgia
city: Woodstock
country: United States
facility: GSK Investigational Site
state: Georgia
city: Avon
country: United States
facility: GSK Investigational Site
state: Indiana
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Fort Wayne
country: United States
facility: GSK Investigational Site
state: Indiana
city: Jeffersonville
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facility: GSK Investigational Site
state: Indiana
city: Wichita
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facility: GSK Investigational Site
state: Kansas
city: Lexington
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facility: GSK Investigational Site
state: Kentucky
city: Madisonville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Shreveport
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Swansea
country: United States
facility: GSK Investigational Site
state: Maine
city: Taunton
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: GSK Investigational Site
state: Michigan
city: Saint Louis Park
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Lawrenceville
country: United States
facility: GSK Investigational Site
state: New Jersey
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: West Seneca
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Shippensburg
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Amarillo
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Menomonee Falls
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: