Erectile DysfunctionPhase 3NCT00661115
To Investigate the 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 6 sites in India.
Trial summary
To investigate the efficacy and safety of vardenafil in men with erectile dysfunction. Read more about this study
- Who is it for?
- Ages 21 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?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 6 sitesIndia
- Study dates
- May 2003to Feb 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months
- having at least a 50% failure rate of sexual intercourse attempts during the run-in phase
Who cannot join
- Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded.
- Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded.
- Subjects could not be on androgens/anti-androgens or alpha blockers.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Study site
Bangalore, Karnataka, 560010
Study site
Bangalore, Karnataka, 560054
Study site
Belagum, Karnataka, 590010
Study site
Madurai, Tamil Nadu, 625107
Study site
Mumbai, Maharashtra, 400007
Study site
Mumbai, Maharashtra, 400022
About this study
Official title: A Randomised, Double Blind, Placebo Controlled, Multi-center, Fixed Dose, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil (BAY 38-9456) in Men With Erectile Dysfunction .
To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.
- Conditions
- Erectile Dysfunction
- Being tested
- Levitra (Vardenafil, BAY38-9456), Placebo
- Keywords
- Erectile dysfunction, Sexual Dysfunction
- Medical subject headings
- Erectile Dysfunction, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levitra (Vardenafil, BAY38-9456)Drug
Vardenafil 10 mg. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks
PlaceboDrug
Placebo. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15
Measured: At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts.
Secondary outcomes (5)
Success in penetration and maintenance as recorded in subject diaries
Measured: At Weeks 4, 8 and 12 (as observed and at LOCF)
Scores for questions 3 and 4 of the IIEF
Measured: At Weeks 4, 8 and 12 (as observed and at LOCF)
Other IIEF domain scores
Measured: At Week 12 (observed and at LOCF)
Global Assessment Question (GAQ) responses
Measured: At Weeks 4, 8 and 12 (as observed and at LOCF)
Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use.
Measured: At Weeks 4, 8 and 12 (as observed and at LOCF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startMay 2003
- Primary completionFeb 2004
- Study completionFeb 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661115
- Sponsor's protocol ID
- 10695
- Status last verified
- Dec 2014
- First submitted
- 15 Apr 2008
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo Controlled, Multi-center, Fixed Dose, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil (BAY 38-9456) in Men With Erectile Dysfunction .
- ClinicalTrials.gov ID
- NCT00661115
- Acronym / sponsor ID
- 10695
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, Sexual Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 18 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 investigate the efficacy and safety of vardenafil in men with erectile dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months
- having at least a 50% failure rate of sexual intercourse attempts during the run-in phase
Key exclusion criteria (3 listed)
- Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded.
- Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded.
- Subjects could not be on androgens/anti-androgens or alpha blockers.
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)Vardenafil 10 mg. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks | Drug | Arm 1 |
| PlaceboPlacebo. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks | Drug | Arm 2 |
Primary outcome
Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15
Time frame: At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts.
5 secondary outcomes
Success in penetration and maintenance as recorded in subject diaries
Time frame: At Weeks 4, 8 and 12 (as observed and at LOCF)
Scores for questions 3 and 4 of the IIEF
Time frame: At Weeks 4, 8 and 12 (as observed and at LOCF)
Other IIEF domain scores
Time frame: At Week 12 (observed and at LOCF)
Global Assessment Question (GAQ) responses
Time frame: At Weeks 4, 8 and 12 (as observed and at LOCF)
Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use.
Time frame: At Weeks 4, 8 and 12 (as observed and at LOCF)
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 16 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
6 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 6 sites in India.
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 2 inclusion and 3 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 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 6 sites in India. 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 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 of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15 (time frame: At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts.). 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 16 Dec 2014.