Erectile DysfunctionPhase 3NCT00657644
Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction
A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction, run by Bayer at 8 sites in Russia.
Trial summary
To find out more information on how effective and safe vardenafil is at treating impotence in men living in Russia. 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)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 8 sitesRussia
- Study dates
- Aug 2003to Mar 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 with ED according to the NIH definition (the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance) for at least 3 months.
- Heterosexual relationship
- Age range: 18 years and older
- Documented written Informed Consent
- 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 partial erection (some enlargement of the penis)?", "Were you able to insert your penis in your partner's vagina?" and "Did your erection last long enough for you to have successful intercourse?".
Who cannot join
- 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) that in the opinion of the Investigator would significantly impair erectile function
- Primary hypoactive sexual desire
- Spinal cord injury
- History of surgical prostatectomy (excluding TURP).
- Retinitis pigmentosa
Show all 31Show fewer
- History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C.
- History of positive test for HIV.9. Severe chronic or acute liver disease, history of moderate or severe hepatic impairment.
- Clinically significant chronic hematological disease, which may lead to priapism such as sickle cell anemia and leukemia.
- Bleeding disorder.
- Significant active peptic ulceration.
- 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).
- 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)
- NYHA Class III and IV heart failure
- Symptomatic postural hypotension within 6 months of visit 1.
- History of malignancy within the past 5 years (other than squamous or basal cell skin cancer).
- Concomitant Medication:
- Subjects who are taking nitrates or nitric oxide donors.
- Subjects who are taking anti-androgens
- Subjects who are taking androgens.
- Subjects who take anticoagulants, except for antiplatelet agents.
- Subjects who have received any investigational drug (including placebo) within 30 days of visit 1.6. Use of any treatment for ED within the 7 days of visit 1 or during the study, including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories.
- Subjects who are taking the following potent inhibitors of cytochrome P- 450 3A4: HIV protease inhibitors such as ritonavir or indinavir, the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin.
- Subjects who are taking alpha-blockers.
- Abnormal Laboratory Values:
- Subjects who have a serum total testosterone level greater than 25% below the 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 >3X the ULN.
- Diabetic subjects with an HbA1c >12%.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Russia8 sites
Study site
Moscow, 105425
Study site
Moscow, 117198
Study site
Moscow, 117837
Study site
Moscow, 117997
Study site
Moscow, 123367
Study site
Moscow, 125101
Study site
Moscow, 127206
Study site
Saint Petersburg, 198013
About this study
Official title: Open-label Multi-centre Non Randomised Study of Efficacy and Safety of Vardenafil (BAY 38-9456; SB-782528) Administered in Flexible-dose Regimen in Males With Erectile Dysfunction of Broad Aetiology.
To find out more information on how effective and safe vardenafil is at treating impotence in men living in Russia.
- Conditions
- Erectile Dysfunction
- Being tested
- Levitra (Vardenafil, BAY38-9456)
- 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
4 weeks treatment with 10 mg vardenafil followed by a flexible titration phase for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Levitra (Vardenafil, BAY38-9456) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile Function (EF) domain score
Measured: Week 12
Secondary outcomes (8)
Erectile Function (EF) domain score
Measured: Week 4, 8 and 12 Last Observation Carried Forward (LOCF)
Change from baseline of Erectile Function domain score
Measured: Week 4, 8 and 12 Last Observation Carried Forward (LOCF)
IIEF domain scores
Measured: Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
Patient Diary Questions
Measured: Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
Global Assessment Question (GAQ)
Measured: Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
Premature termination, adverse events, laboratory abnormalities and concomitant medication usage
Measured: Week 4, 8 and 12
Measurements and changes from baseline in vital signs, ECG cardiac cycle measurements and ECG heart rate
Measured: Week 12
Haematology, Clinical Chemistry, Urinalysis
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startAug 2003
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657644
- Sponsor's protocol ID
- 11182
- Status last verified
- Dec 2014
- First submitted
- 8 Apr 2008
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Multi-centre Non Randomised Study of Efficacy and Safety of Vardenafil (BAY 38-9456; SB-782528) Administered in Flexible-dose Regimen in Males With Erectile Dysfunction of Broad Aetiology.
- ClinicalTrials.gov ID
- NCT00657644
- Acronym / sponsor ID
- 11182
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- Aug 2003
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find out more information on how effective and safe vardenafil is at treating impotence in men living in Russia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Levitra (Vardenafil, BAY38-9456) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males with ED according to the NIH definition (the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance) for at least 3 months.
- Heterosexual relationship
- Age range: 18 years and older
- Documented written Informed Consent
- 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 partial erection (some enlargement of the penis)?", "Were you able to insert your penis in your partner's vagina?" and "Did your erection last long enough for you to have successful intercourse?".
Key exclusion criteria (31 listed)
- 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) that in the opinion of the Investigator would significantly impair erectile function
- Primary hypoactive sexual desire
- Spinal cord injury
- History of surgical prostatectomy (excluding TURP).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levitra (Vardenafil, BAY38-9456)4 weeks treatment with 10 mg vardenafil followed by a flexible titration phase for 8 weeks | Drug | Arm 1 |
Primary outcome
Erectile Function (EF) domain score
Time frame: Week 12
8 secondary outcomes
Erectile Function (EF) domain score
Time frame: Week 4, 8 and 12 Last Observation Carried Forward (LOCF)
Change from baseline of Erectile Function domain score
Time frame: Week 4, 8 and 12 Last Observation Carried Forward (LOCF)
IIEF domain scores
Time frame: Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
Patient Diary Questions
Time frame: Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
Global Assessment Question (GAQ)
Time frame: Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
Premature termination, adverse events, laboratory abnormalities and concomitant medication usage
Time frame: Week 4, 8 and 12
Measurements and changes from baseline in vital signs, ECG cardiac cycle measurements and ECG heart rate
Time frame: Week 12
Haematology, Clinical Chemistry, Urinalysis
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
8 sites in 1 country: see every site and its status.
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 8 sites in Russia.
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 5 inclusion and 31 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 25 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Russia. 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?
Erectile Function (EF) domain score (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Dec 2014.