A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia

NCT00379756 | Completed Phase 4

• 1 other identifier: 106718
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 65

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.

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction, impotence

Outcome Measures

Primary Outcomes (3)

• Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)

  The IIEF questionnaire is a validated 15-item instrument that assesses the participant's erectile function over the previous 4 weeks. The IIEF includes 5 domains affecting male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Responses to the IIEF were re-coded using a standard coding method, where more positive responses received a higher score. The EF domain score was calculated as the sum of the re-coded scores from questions 1-5 and 15, using last observation carried forward (LOCF). Scores range from 1 (lowest) to 30 (highest). If two or more items in the EF domain were missing, the EF domain score was considered to be missing.

  Up to Week 12

• Mean success rate of insertion based on attempts

  Success rate of insertion was derived from the Sexual Encounter Profile (SEP) Question 2 (SEP-2) of the participant's diary that asked 'Were you able to insert your penis into your partner's vagina?'. Responses were either Yes or No. Patients were instructed to complete diary questions as soon as possible after each sexual attempt, but no later than 24 hours after the attempt. The per-participant overall success rate for insertion was calculated by dividing the number of successful attempts (SEP-2=yes) over 12 weeks by the total number of valid attempts recorded over 12 weeks. If the participant was not able to make any valid attempts in 12 weeks, the participant was non-evaluable. Per-participant success rates were then averaged at the group level to obtain the mean success rate from Weeks 0-12.

  Up to Week 12

• Mean success rates of maintenance based on attempts

  Success rate of maintenance was derived from the SEP Question 3 (SEP-3) of the participant's diary that asked 'Did your erection last long enough for you to have successful intercourse?'. Responses were either Yes or No. Participants were instructed to complete diary questions as soon as possible after each sexual attempt, but no later than 24 hours after the attempt. The per-participant overall success rate for maintenance was calculated by dividing the number of successful attempts (SEP-3=yes) over 12 weeks by the total number of valid attempts recorded over 12 weeks. If the participant was not able to make any valid attempts in 12 weeks, the participant was non-evaluable. Per-participant success rates were then averaged at the group level to obtain the mean success rate from Weeks 0-12.

  Up to Week 12

Secondary Outcomes (8)

• Mean duration of erection leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 [SEP-3]

  Up to Week 12

• Change from Baseline in scores for questions on the IIEF questionnaire and scores of the other non-EF domains of the IIEF

  Up to Week 12

• Number of participants with normal erectile function having EF domain scores of 26 and above

  Up to Week 12

• Change from Baseline in participant's diary results

  Up to Week 12

• Mean duration of erection regardless of SEP-3 Response

  Up to Week 12

Study Arms (2)

Levitra

ACTIVE COMPARATOR

10mg x 4 weeks, with option to increase to 20mg aat that time if desired

Drug: LEVITRA (vardenafil)

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

LEVITRA (vardenafil) DRUG

active comparator

Levitra

placebo DRUG

placebo comparator

placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• serum total testosterone level \>25% below the lower limit of normal

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (65)

GSK Investigational Site

Fairhope, Alabama, 36532, United States

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GSK Investigational Site

Homewood, Alabama, 35209, United States

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GSK Investigational Site

Huntsville, Alabama, 35801, United States

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GSK Investigational Site

Phoenix, Arizona, 85016, United States

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GSK Investigational Site

Phoenix, Arizona, 85023, United States

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GSK Investigational Site

Concord, California, 94520, United States

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GSK Investigational Site

Huntington Park, California, 90255, United States

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GSK Investigational Site

Long Beach, California, 90806, United States

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GSK Investigational Site

Modesto, California, 95350, United States

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Newport Beach, California, 92660, United States

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Orangevale, California, 95662, United States

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Santa Ana, California, 92705, United States

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GSK Investigational Site

Walnut Creek, California, 94598, United States

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Denver, Colorado, 80210, United States

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Wheat Ridge, Colorado, 80033, United States

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New Britain, Connecticut, 06052, United States

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Aventura, Florida, 33180, United States

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Clearwater, Florida, 33761, United States

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Coral Gables, Florida, 33134, United States

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Fort Myers, Florida, 33916, United States

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North Miami, Florida, 33161, United States

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Orlando, Florida, 32803, United States

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Pembroke Pines, Florida, 33024, United States

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Pinecrest, Florida, 33156, United States

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Sarasota, Florida, 34237, United States

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GSK Investigational Site

South Miami, Florida, 33143, United States

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St. Petersburg, Florida, 33710, United States

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Tampa, Florida, 33607, United States

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West Palm Beach, Florida, 33401, United States

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Atlanta, Georgia, 30342, United States

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Columbus, Georgia, 31904, United States

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Dawsonville, Georgia, 30534, United States

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Roswell, Georgia, 30076, United States

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GSK Investigational Site

Woodstock, Georgia, 30189, United States

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Avon, Indiana, 46123, United States

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Evansville, Indiana, 47714, United States

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Fort Wayne, Indiana, 46825, United States

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Jeffersonville, Indiana, 47130, United States

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Wichita, Kansas, 67207, United States

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Lexington, Kentucky, 40509, United States

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Madisonville, Kentucky, 42431, United States

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Shreveport, Louisiana, 71106, United States

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Swansea, Maine, 02777, United States

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Taunton, Massachusetts, 02780, United States

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Kalamazoo, Michigan, 49009, United States

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Saint Louis Park, Minnesota, 55416, United States

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St Louis, Missouri, 63117, United States

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Omaha, Nebraska, 68134, United States

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GSK Investigational Site

Las Vegas, Nevada, 89119, United States

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GSK Investigational Site

Lawrenceville, New Jersey, 08648, United States

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New York, New York, 10016, United States

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GSK Investigational Site

Rochester, New York, 14609, United States

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GSK Investigational Site

West Seneca, New York, 14224, United States

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GSK Investigational Site

Charlotte, North Carolina, 28262, United States

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GSK Investigational Site

Fayetteville, North Carolina, 28304, United States

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GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

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GSK Investigational Site

Shippensburg, Pennsylvania, 17257, United States

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GSK Investigational Site

Nashville, Tennessee, 37203, United States

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GSK Investigational Site

Amarillo, Texas, 79106, United States

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GSK Investigational Site

Salt Lake City, Utah, 84107, United States

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GSK Investigational Site

Norfolk, Virginia, 23502, United States

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GSK Investigational Site

Richmond, Virginia, 23294, United States

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GSK Investigational Site

Seattle, Washington, 98166, United States

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GSK Investigational Site

Menomonee Falls, Wisconsin, 53051, United States

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GSK Investigational Site

Milwaukee, Wisconsin, 53209, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2006
• First Posted: September 22, 2006
• Study Start: May 22, 2006
• Primary Completion: May 17, 2007
• Study Completion: May 17, 2007
• Last Updated: August 16, 2017

Record last verified: 2017-08

Locations

US (65)