Erectile DysfunctionPhase 3NCT00668057
BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction, run by Bayer at 7 sites in China.
Trial summary
This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks. Read more about this study
- Who is it for?
- Ages 22 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
- 624 participants
- Where
- 7 sitesChina
- Study dates
- Dec 2002to Sep 2003
- 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 22 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
- Stable heterosexual relationship
Who cannot join
- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
- Nitrate use
- Other exclusion criteria apply
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Study site
Beijing, 100034
Study site
Beijing, 100044
Study site
Beijing, 100083
Study site
Beijing, 100853
Study site
Hangzhou, Zhejiang, 310003
Study site
Shanghai, 200040
Study site
Shanghai, 200127
About this study
Official title: Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction
This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.
- Conditions
- Erectile Dysfunction
- Being tested
- Levitra (Vardenafil, BAY38-9456), Placebo
- Keywords
- Male 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
5 mg Vardenafil orally 1 hour prior to sexual intercourse
Levitra (Vardenafil, BAY38-9456)Drug
10 mg Vardenafil orally 1 hour prior to sexual intercourse
Levitra (Vardenafil, BAY38-9456)Drug
20 mg Vardenafil orally 1 hour prior to sexual intercourse
PlaceboDrug
5 mg matching placebo
PlaceboDrug
10 mg matching placebo
PlaceboDrug
20 mg matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 2 | Experimental | Not described Receives: Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 3 | Experimental | Not described Receives: Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 4 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 5 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 6 | 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 domain score of the International Index of Erectile Function, questions 1-5 and 15
Measured: 12 weeks
Secondary outcomes (3)
Global Assessment Questionnaire
Measured: 12 weeks
Erectile Function domain score of the International Index of Erectile Function
Measured: 12 weeks
Safety and tolerability
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startDec 2002
- Primary completionSep 2003
- Study completionSep 2003
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
- 624 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
- NCT00668057
- Sponsor's protocol ID
- 10690
- Status last verified
- Mar 2015
- First submitted
- 24 Apr 2008
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT00668057
- Acronym / sponsor ID
- 10690
- Conditions
- Erectile Dysfunction
- Keywords
- Male Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 28 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.
This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 2 | Experimental | Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 3 | Experimental | Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 4 | Placebo comparator | Drug: Placebo |
| Arm 5 | Placebo comparator | Drug: Placebo |
| Arm 6 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 22 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
- Stable heterosexual relationship
Key exclusion criteria (3 listed)
- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
- Nitrate use
- Other exclusion criteria apply
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)5 mg Vardenafil orally 1 hour prior to sexual intercourse | Drug | Arm 1 |
| Levitra (Vardenafil, BAY38-9456)10 mg Vardenafil orally 1 hour prior to sexual intercourse | Drug | Arm 2 |
| Levitra (Vardenafil, BAY38-9456)20 mg Vardenafil orally 1 hour prior to sexual intercourse | Drug | Arm 3 |
| Placebo5 mg matching placebo | Drug | Arm 4 |
| Placebo10 mg matching placebo | Drug | Arm 5 |
| Placebo20 mg matching placebo | Drug | Arm 6 |
Primary outcome
Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15
Time frame: 12 weeks
3 secondary outcomes
Global Assessment Questionnaire
Time frame: 12 weeks
Erectile Function domain score of the International Index of Erectile Function
Time frame: 12 weeks
Safety and tolerability
Time frame: 12 weeks
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 6 Mar 2015.
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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
7 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 7 sites in China.
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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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 domain score of the International Index of Erectile Function, questions 1-5 and 15 (time frame: 12 weeks). 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 6 Mar 2015.