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Erectile DysfunctionPhase 4NCT00379756

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

A Phase 4 study testing LEVITRA (vardenafil) in people with Erectile Dysfunction, run by GlaxoSmithKline at 65 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
LEVITRA (vardenafil)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
395 participants
Where
65 sitesUnited States
Study dates
22 May 2006to 17 May 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • serum creatinine >3.0 mg/dl.
  • AST and/or ALT >3x the upper limit of normal.

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • GSK Investigational Site

    Amarillo, Texas, 79106

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Avon, Indiana, 46123

  • GSK Investigational Site

    Charlotte, North Carolina, 28262

  • GSK Investigational Site

    Clearwater, Florida, 33761

  • GSK Investigational Site

    Columbus, Georgia, 31904

  • GSK Investigational Site

    Concord, California, 94520

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Dawsonville, Georgia, 30534

  • GSK Investigational Site

    Denver, Colorado, 80210

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Fairhope, Alabama, 36532

  • GSK Investigational Site

    Fayetteville, North Carolina, 28304

  • GSK Investigational Site

    Fort Myers, Florida, 33916

  • GSK Investigational Site

    Fort Wayne, Indiana, 46825

  • GSK Investigational Site

    Homewood, Alabama, 35209

  • GSK Investigational Site

    Huntington Park, California, 90255

  • GSK Investigational Site

    Huntsville, Alabama, 35801

  • GSK Investigational Site

    Jeffersonville, Indiana, 47130

  • GSK Investigational Site

    Kalamazoo, Michigan, 49009

  • GSK Investigational Site

    Las Vegas, Nevada, 89119

  • GSK Investigational Site

    Lawrenceville, New Jersey, 08648

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    Long Beach, California, 90806

  • GSK Investigational Site

    Madisonville, Kentucky, 42431

  • GSK Investigational Site

    Menomonee Falls, Wisconsin, 53051

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53209

  • GSK Investigational Site

    Modesto, California, 95350

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New Britain, Connecticut, 06052

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Newport Beach, California, 92660

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    North Miami, Florida, 33161

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Orangevale, California, 95662

  • GSK Investigational Site

    Orlando, Florida, 32803

  • GSK Investigational Site

    Pembroke Pines, Florida, 33024

  • GSK Investigational Site

    Phoenix, Arizona, 85016

  • GSK Investigational Site

    Phoenix, Arizona, 85023

  • GSK Investigational Site

    Pinecrest, Florida, 33156

  • GSK Investigational Site

    Richmond, Virginia, 23294

  • GSK Investigational Site

    Rochester, New York, 14609

  • GSK Investigational Site

    Roswell, Georgia, 30076

  • GSK Investigational Site

    Saint Louis Park, Minnesota, 55416

  • GSK Investigational Site

    Salt Lake City, Utah, 84107

  • GSK Investigational Site

    Santa Ana, California, 92705

  • GSK Investigational Site

    Sarasota, Florida, 34237

  • GSK Investigational Site

    Seattle, Washington, 98166

  • GSK Investigational Site

    Shippensburg, Pennsylvania, 17257

  • GSK Investigational Site

    Shreveport, Louisiana, 71106

  • GSK Investigational Site

    South Miami, Florida, 33143

  • GSK Investigational Site

    St Louis, Missouri, 63117

  • GSK Investigational Site

    St. Petersburg, Florida, 33710

  • GSK Investigational Site

    Swansea, Maine, 02777

  • GSK Investigational Site

    Tampa, Florida, 33607

  • GSK Investigational Site

    Taunton, Massachusetts, 02780

  • GSK Investigational Site

    Walnut Creek, California, 94598

  • GSK Investigational Site

    West Palm Beach, Florida, 33401

  • GSK Investigational Site

    West Seneca, New York, 14224

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80033

  • GSK Investigational Site

    Wichita, Kansas, 67207

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Woodstock, Georgia, 30189

Other trials in United States

About this study

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

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.

Being tested
LEVITRA (vardenafil), placebo
Keywords
Erectile dysfunction, impotence
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LEVITRA (vardenafil)Drug

    active comparator

  • placeboDrug

    placebo comparator

Study groups in NCT00379756
Study groupRoleWhat they receive
LevitraActive comparator10mg x 4 weeks, with option to increase to 20mg aat that time if desired
Receives: Drug: LEVITRA (vardenafil)
placeboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Week 12

  2. 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.

    Measured: Up to Week 12

  3. 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.

    Measured: Up to Week 12

Secondary outcomes (8)

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

    Duration of erection leading to completion of successful intercourse was derived from data recorded in the participant's diary. For each diary entry, the time from erection perceived hard enough for penetration until withdrawal from partner's vagina was measured by stopwatch and recorded in the participant's diary. For diary entries where SEP-3=yes, this recorded duration was used in calculations of a per-participant median duration. For diary entries where SEP-3=no, a duration of 0 was used to calculate the per-participant median. The per-participant median values averaged at the group level to obtain the mean duration of erection leading to completion of successful intercourse as measured by SEP-3.

    Measured: Up to Week 12

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

    Non-EF domains of the IIEF (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, Overall Satisfaction) and IIEF questions (Erection during sexual activity?, Hard enough for penetration?, Able to penetrate partner?, Maintain your erection?, Maintain to completion?, Times attempted intercourse, Satisfactory for you?, Enjoyed sexual intercourse?, How often did you ejaculate?, How often feeling of orgasm?, How often felt sexual desire?, Rate level of sexual desire?, How satisfied with sex life?, Satisfied with sexual relationship? and Confidence to get, keep erection?) scores were assessed at Week 4, Week 8 and Week 12. The Baseline was the value at Week 0. Change from Baseline was the post-Baseline value minus Baseline value.

    Measured: Up to Week 12

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

    The EF domain score was calculated by summing recoded responses to Questions 1-5 and 15, for each participant. It ranged from 1 to 30. EF domain scores were dichotomized as either normal (26 and above) or below normal (below 26) using LOCF, to calculate number of participants returning to normal erectile function. For the EF domain score the total was considered to be missing if 2 or more answers in the domain were missing.

    Measured: Up to Week 12

  4. Change from Baseline in participant's diary results

    Electronic diaries were provided to participants. Participants were supposed to complete the diary questions as soon as possible after each sexual attempt but no later than 24 hours after the attempts. The diary questions (Ability to achieve at least some erection, Ability to insert penis into partner's vagina, Long enough erection having successful intercourse, Satisfied with the hardness of erection, Satisfied with this sexual experience, Ability to ejaculate) response rates were presented for Weeks 0-12. The Baseline was the value at Week 0. Change from Baseline was the post-Baseline value minus Baseline value.

    Measured: Up to Week 12

  5. Mean duration of erection regardless of SEP-3 Response

    Duration of erection was time from erection perceived hard enough for penetration (start stopwatch) until withdrawal from the partner's vagina (stop stopwatch) regardless of completion of successful intercourse. The data was presented for overall period from Week 0 to Week 12.

    Measured: Up to Week 12

  6. Change from Baseline in duration of erection leading to completion of successful intercourse.

    Duration of erection was time from erection perceived hard enough for penetration (start stopwatch) until withdrawal from the partner's vagina (stop stopwatch) leading to completion of successful intercourse. The data was presented for overall period from Week 0 to Week 12. The Baseline was the value at Week 0. Change from Baseline was the post-Baseline value minus Baseline value.

    Measured: Up to Week 12

  7. Number of participants with response 'Yes' for Global Assessment Question

    The participants were asked to complete the self-administered Global Assessment Question. The question asked was 'has the treatment you have been taking over the past 4 weeks improved your erections'. The response was either Yes or No depending on comparison to participant's erections before their participation in this study. For the scale missing values remained missing.

    Measured: Up to Week 12

  8. Mean score for Keep It Simple (KIS) scale

    The KIS scale was a self-reported visual analog scale (VAS) from 0 to 10 designed to assess erections as 'how do you grade your erections over the last 4 weeks?'. For the scale missing values remained as missing.

    Measured: Up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2006 (estimated)
  2. Study start22 May 2006
  3. Primary completion17 May 2007
  4. Study completion17 May 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
395 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00379756
Sponsor's protocol ID
106718
Status last verified
Aug 2017
First submitted
21 Sep 2006
Last updated
16 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing LEVITRA (vardenafil) in people with Erectile Dysfunction, run by GlaxoSmithKline at 65 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Erectile function (EF) domain score of the International Index of Erectile Function (IIEF) (time frame: Up to Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00379756.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2017.

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