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Erectile DysfunctionPhase 3NCT00657033

Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction

A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction, run by Bayer at 26 sites in 2 countries.

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

Study to investigate the efficacy and safety of vardenafil flexible dose versus placebo in males with erectile dysfunction, and their female partners' sexual quality of life. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Levitra (Vardenafil, BAY38-9456)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
229 participants
Where
26 sitesin 2 countries
Study dates
Oct 2003to Aug 2004
Phase
Phase 3
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males who have had ED for at least six months according to the National Institutes of Health (NIH) Consensus Conference December 7-9, 1992 (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
  • Stable, heterosexual relationship for more than 6 months.
  • Males 18 years, and older.
  • Written informed consent obtained.
  • The subject and his female partner must make at least four attempts at sexual intercourse on four separate days during the untreated baseline period (according to the answer to the following question in the Patient Diary: "Was sexual activity initiated with the intention of intercourse?").
  • At least 50% of attempts at sexual intercourse during the untreated baseline 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 in your partner's vagina?"; "Did your erection last long enough for you to have successful intercourse?".

Who cannot join

  • Previous or current medical conditions:
  • Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
  • Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease) which, in the Investigator's opinion, would significantly impair erectile function.
  • Primary hypoactive sexual desire.
  • Spinal cord injury.
  • History of surgical prostatectomy (excluding TURP).
Show all 44Show fewer
  • Retinitis pigmentosa.
  • Unstable angina pectoris.
  • History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
  • Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate \≥ 100 bpm).
  • Severe chronic or acute liver disease, history of moderate or severe hepatic impairment.
  • Clinically significant chronic haematological disease which may lead to priapism such as sickle cell anemia and leukemia.
  • Bleeding disorder.
  • Significant active peptic ulcer disease.
  • Resting hypotension (a resting systolic blood pressure of < 90 mm Hg) or hypertension (a resting systolic blood pressure > 170 mm Hg or a resting diastolic blood pressure > 110 mm Hg).
  • History of malignancy within the past 5 years (other than squamous or basal cell skin cancer).
  • NYHA Class III and IV heart failure.
  • History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C.
  • Symptomatic postural hypotension within 6 months of visit 1.
  • Concomitant medication:
  • Subjects who are taking nitrates or nitric oxide donors.
  • Subjects who take anticoagulants, except for antiplatelet agents.
  • Subjects who are taking androgens.
  • Subjects who are taking anti-androgens.
  • Subjects who are taking the following inhibitors of cytochrome P450 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin.
  • Subjects who have received any investigational drug (including placebo) within 30 days of Visit 1.
  • Use of any treatment for ED within 7 days of visit 1 or during the study, including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories.
  • Subjects who are taking alpha blockers
  • Abnormal laboratory values:
  • Subjects who have a serum total testosterone level more than 25% below the age-adjusted lower limit of normal according to the range of the testing laboratory.
  • Subjects with a serum creatinine > 3.0 mg/dl.
  • Elevation of AST and/or ALT > 3 times the upper limit of normal.
  • Diabetic subjects with an HbA1c>12%.
  • Other Exclusion Criteria:
  • Subjects age 65 or older who in the judgment of the investigator can not be started on a 10 mg dose
  • Subjects with a history of unresponsiveness to any PDE 5 Inhibitor treatment due to lack of efficacy or significant side effects leading to discontinuation of the PDE 5 Inhibitor treatment.
  • Subjects unwilling to cease use of vacuum devices, intracavernosal injections, Viagra® or other therapy for ED during the study.
  • Unwillingness of the subject or his partner to make 4 attempts at sexual intercourse on four separate days during the untreated baseline period.
  • Subjects with known hypersensitivity to Vardenafil, Bay 38-9456 (also known as SB-782528) or any component of the investigational medication.
  • Subjects who are illiterate or unable to understand the questionnaires or the Patient Diary.
  • Partners who are illiterate or unable to understand the questionnaires.
  • Subjects who are unwilling or unable to complete the Patient Diary.
  • Subjects or partners who, in the opinion of the investigator, would be non-compliant with the visit schedule of study procedures.
  • Subjects unwilling to refrain from consuming grapefruit juice or products containing grapefruit juice with study medication (Canada only).

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States18 sites

  • Study site

    Beverly Hills, California, 90212

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Greenbelt, Maryland, 20770

  • Study site

    Irvine, California, 92618-3603

  • Study site

    Jacksonville, Florida, 32257

  • Study site

    Lawrenceville, New Jersey, 08648

  • Study site

    Lutherville, Maryland, 21093

  • Study site

    New Brunswick, New Jersey, 08901

  • Study site

    New York, New York, 10016

  • Study site

    Newport Beach, California, 92660

  • Study site

    Phoenix, Arizona, 85023

  • Study site

    Riverdale, Georgia, 30274

  • Study site

    San Bernardino, California, 92404

  • Study site

    San Diego, California, 92101

  • Study site

    San Diego, California, 92128

  • Study site

    Statesville, North Carolina, 28677

  • Study site

    Trumbull, Connecticut, 06611

  • Study site

    Wilmington, North Carolina, 28412

Other trials in United States

Canada8 sites

  • Study site

    Barrie, Ontario, L4M 4S5

  • Study site

    Burlington, Ontario, L7N 3V2

  • Study site

    Calgary, Alberta, T2V 4R6

  • Study site

    Kitchener, Ontario, N2M 5N4

  • Study site

    London, Ontario, N6A 4V2

  • Study site

    Oakville, Ontario, L6H 3P1

  • Study site

    Saskatoon, Saskatchewan, S7M 0Z9

  • Study site

    Victoria, V8T 5G1

Other trials in Canada

About this study

Official title: A Randomized, Double Blind, Parallel Group, Multi-center Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction, and Their Female Partners' Sexual Quality of Life.

Study to investigate the efficacy and safety of vardenafil flexible dose versus placebo in males with erectile dysfunction, and their female partners' sexual quality of life.

Being tested
Levitra (Vardenafil, BAY38-9456), Placebo
Keywords
Erectile Dysfunction
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, BAY38-9456)Drug

    BAY 38-9456 (Vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.

  • PlaceboDrug

    Identical placebo tablets will be matched for each vardenafil dosage and will be indistinguishable from active treatment

Study groups in NCT00657033
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Levitra (Vardenafil, BAY38-9456)
Arm 2ExperimentalNot described
Receives: Drug: Placebo

What is being measured

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

  1. The primary measures of efficacy in this study will be improved success of erection maintenance in men with ED and improvement in female partner's sexual quality of life.

    Measured: Weeks 0 -12

Secondary outcomes (8)

  1. SEP3 at weeks 4 and 12 of treatment compared to placebo.

    Measured: Weeks 4 and 12

  2. Additional Patient Diary questions at 4 weeks, 8 weeks, 12 weeks, LOCF, and over entire treatment period compared to placebo. Per-subject success rates will be calculated as the number of successes divided by the number of sexual attempts with a resp

    Measured: Weeks 4, 8 and 12

  3. Global assessment question (GAQ) at weeks 4 and 12 of treatment compared to placebo

    Measured: Weeks 4 and 12

  4. Global confidence question (GCQ) at 12 weeks of treatment compared to placebo.

    Measured: Week 12

  5. The score for the IIEF questionnaire EF domain (IIEF-EF) at weeks 4, 12, and LOCF of treatment compared to placebo

    Measured: Weeks 4 and 12

  6. Scores from the Treatment Satisfaction Scale (TSS) -- Subject Active Medication module at week 12 and LOCF of treatment compared to placebo. The TSS is a self-report measure of subject and partner's satisfaction with various aspects of erectile function

    Measured: Week 12

  7. Scores from the mSLQQ-QOL at week 12 and LOCF of treatment compared to placebo

    Measured: Week 12

  8. Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25) at week 12 of treatment compared to placebo.

    Measured: 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 posted14 Apr 2008 (estimated)
  2. Study startOct 2003
  3. Study completionAug 2004

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00657033
Sponsor's protocol ID
100519
Status last verified
Oct 2013
First submitted
9 Apr 2008
Last updated
14 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction, run by Bayer at 26 sites in 2 countries.

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 44 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 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Canada. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The primary measures of efficacy in this study will be improved success of erection maintenance in men with ED and improvement in female partner's sexual quality of life. (time frame: Weeks 0 -12). 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 NCT00657033.

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 14 Oct 2013.

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