Erectile DysfunctionPhase 3NCT00652262
BAY38-9456 - Supportive Trial for Spinal Injury
A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction and Sexual Dysfunction, run by Bayer at 3 sites in Japan.
Trial summary
BAY 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be improved by uptitration to BAY 38-9456 20 mg when the treatment with 10 mg is not sufficiently effective Read more about this study
- Who is it for?
- Ages 20 to 64 years, men only
- Conditions the study is for
- Erectile Dysfunction, Sexual Dysfunction, Spinal Cord Injury
- What is being tested?
- Levitra (Vardenafil, BAY38-9456)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesJapan
- Study dates
- Mar 2004to Nov 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 20 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male with erectile dysfunction according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance), solely as a result of a traumatic injury to the spinal cord (suffering more than 6 months ago)
- Patients answering "yes" to the question regarding the presence of residual erectile function over the past 6 months [At home over the past 6 months, have you experienced at least some enlargement of your penis in response to: (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?]
Who cannot join
- History of diabetes mellitus
- Patients who are taking nitrates or nitric oxide donors
- Patients who have experienced no enlargement of penis with PDE5 inhibitor and/or who have withdrew the use of PDE5 inhibitor due to ADRs
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Study site
Beppu, Oita Prefecture, 874-0937
Study site
Iizuka, Fukuoka, 820-0053
Study site
Nagoya, Aichi-ken, 455-8530
About this study
Official title: An Open, Multi-centre, Flexible Dose Uptitration Study to Investigate the Efficacy and Safety of Vardenafil 10 mg and 20 mg in Males With Spinal Cord Injury Suffering From Erectile Dysfunction
BAY 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be improved by uptitration to BAY 38-9456 20 mg when the treatment with 10 mg is not sufficiently effective
- Conditions
- Erectile Dysfunction, Sexual Dysfunction, Spinal Cord Injury
- Being tested
- Levitra (Vardenafil, BAY38-9456)
- Keywords
- Vardenafil, PDE5 inhibitor, Erectile dysfunction, Spinal cord injury
- Medical subject headings
- Erectile Dysfunction, Sexual Dysfunction, Physiological, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levitra (Vardenafil, BAY38-9456)Drug
Patients received BAY 38-9456 10 mg for the first 4 weeks of the treatment period, and then went on to receive 10 mg or 20 mg for the following 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.
The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15
Measured: At 12 weeks after start of study drug administration using data at LOCF to account for dropouts
Secondary outcomes (6)
The Global Assessment Question
Measured: At 4, 8, 12 weeks after start of study drug administration and LOCF
The IIEF EF domain score
Measured: At 4, 8, 12 weeks after start of study drug administration
IIEF domain scores other than the EF domain score[intercourse satisfaction (Q6 to Q8), overall satisfaction (Q13, Q14), orgasmic function (Q9, Q10), sexual desire (Q11, Q12)]
Measured: At 4, 8, 12 weeks after start of study drug administration and LOCF
Scores of Questions 1 to 15 on the IIEF Questionnaire
Measured: At 4, 8, 12 weeks after start of study drug administration and LOCF
Patient's diary response concerning hardness of erection, maintenance of erection, satisfaction with overall hardness of erection, ability of insertion, overall satisfaction with sexual experience and ejaculation
Measured: At 4, 8, 12 weeks after start of study drug administration and LOCF
Safety data
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMar 2004
- Study completionNov 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
- 32 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
- NCT00652262
- Sponsor's protocol ID
- 100608
- Status last verified
- Dec 2014
- First submitted
- 1 Apr 2008
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multi-centre, Flexible Dose Uptitration Study to Investigate the Efficacy and Safety of Vardenafil 10 mg and 20 mg in Males With Spinal Cord Injury Suffering From Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT00652262
- Acronym / sponsor ID
- 100608
- Conditions
- Erectile Dysfunction, Sexual Dysfunction, Spinal Cord Injury
- Keywords
- Vardenafil, PDE5 inhibitor, Erectile dysfunction, Spinal cord injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Nov 2004 (actual)
- First posted
- 3 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.
BAY 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be improved by uptitration to BAY 38-9456 20 mg when the treatment with 10 mg is not sufficiently effective
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
- 20 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male with erectile dysfunction according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance), solely as a result of a traumatic injury to the spinal cord (suffering more than 6 months ago)
- Patients answering "yes" to the question regarding the presence of residual erectile function over the past 6 months [At home over the past 6 months, have you experienced at least some enlargement of your penis in response to: (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?]
Key exclusion criteria (3 listed)
- History of diabetes mellitus
- Patients who are taking nitrates or nitric oxide donors
- Patients who have experienced no enlargement of penis with PDE5 inhibitor and/or who have withdrew the use of PDE5 inhibitor due to ADRs
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)Patients received BAY 38-9456 10 mg for the first 4 weeks of the treatment period, and then went on to receive 10 mg or 20 mg for the following 8 weeks. | Drug | Arm 1 |
Primary outcome
The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15
Time frame: At 12 weeks after start of study drug administration using data at LOCF to account for dropouts
6 secondary outcomes
The Global Assessment Question
Time frame: At 4, 8, 12 weeks after start of study drug administration and LOCF
The IIEF EF domain score
Time frame: At 4, 8, 12 weeks after start of study drug administration
IIEF domain scores other than the EF domain score[intercourse satisfaction (Q6 to Q8), overall satisfaction (Q13, Q14), orgasmic function (Q9, Q10), sexual desire (Q11, Q12)]
Time frame: At 4, 8, 12 weeks after start of study drug administration and LOCF
Scores of Questions 1 to 15 on the IIEF Questionnaire
Time frame: At 4, 8, 12 weeks after start of study drug administration and LOCF
Patient's diary response concerning hardness of erection, maintenance of erection, satisfaction with overall hardness of erection, ability of insertion, overall satisfaction with sexual experience and ejaculation
Time frame: At 4, 8, 12 weeks after start of study drug administration and LOCF
Safety data
Time frame: Throughout the study
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 23 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
3 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 and Sexual Dysfunction, run by Bayer at 3 sites in Japan.
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 23 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 3 sites in Japan. 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 Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15 (time frame: At 12 weeks after start of study drug administration using data at LOCF 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 23 Dec 2014.