Erectile DysfunctionPhase 1NCT01110590
Multiple Dose Escalation Study (14 Days) to Investigate Safety, Tolerability, PK and PD of Vardenafil and BAY60-4552
A Phase 1 study testing BAY60-4552 + Vardenafil in people with Erectile Dysfunction, run by Bayer at 1 site in Germany.
Trial summary
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552 and vardenafil will be given with patients with erectile dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- BAY60-4552 + Vardenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to May 2010
- Phase
- Phase 1
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The informed consent must be signed before any study specific tests or procedures are done
- Male patients with a history of erectile dysfunction (ED) for at least 6 months, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse" by the NIH consensus report 1993. The diagnosis of 'Erectile dysfunction' has to be confirmed by a physician
- Age: 18 to 70 years (inclusive) at the first screening examination
- Ethnicity: White
- Body mass index (BMI): equal to or above 18 and below 32 kg / m²
- Confirmation of the patient's health insurance coverage prior to the first screening examination / visit
- Ability to understand and follow study-related instructions
Who cannot join
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity according to the NIH consensus report 1993
- History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to screening
- Bleeding disorder
Show all 10Show fewer
- History of prostatectomy because of prostate cancer, including nerve-sparing techniques. Clarification: Any surgical procedures for the treatment of Benign Prostate Hypertrophy (BPH) are permitted, with the exception of cryosurgery, cryotherapy or cryoablation
- Hereditary degenerative retinal disorders such as retinitis pigmentosa
- History of loss of vision because of NAION (Bayer Study 12912), temporary or permanent loss of vision, including unilateral loss of vision
- History of uni- or bilateral hearing loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Group-comparison, Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administration of Different Doses of Vardenafil (2 Dose Strengths) and BAY60-4552 (4 Dose Strengths) Given Once-daily (od) Over 14 Days in Patients With Erectile Dysfunction (ED).
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552 and vardenafil will be given with patients with erectile dysfunction.
- Conditions
- Erectile Dysfunction
- Being tested
- BAY60-4552 + Vardenafil, 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.
BAY60-4552 + VardenafilDrug
Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil
BAY60-4552 + VardenafilDrug
Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil
BAY60-4552 + VardenafilDrug
Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY60-4552 + Vardenafil |
| Arm 2 | Experimental | Not described Receives: Drug: BAY60-4552 + Vardenafil |
| Arm 3 | Experimental | Not described Receives: Drug: BAY60-4552 + Vardenafil |
| Arm 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event reporting
Measured: up to 6 weeks
Secondary outcomes (2)
Plasma concentration of study drugs; Pharmacokinetic parameters: AUC, Cmax, AUC/D, Cmax;norm, Cmax/D, t1/2, tmax
Measured: Day 0, 6, 13
Plasma concentration of cyclic guanosine monophosphate (cGMP)
Measured: Day 0, 6, 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionMay 2010
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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110590
- Sponsor's protocol ID
- 14612
- Other IDs
- 2009-015894-11, 2009
- Status last verified
- Feb 2013
- First submitted
- 14 Apr 2010
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Group-comparison, Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administration of Different Doses of Vardenafil (2 Dose Strengths) and BAY60-4552 (4 Dose Strengths) Given Once-daily (od) Over 14 Days in Patients With Erectile Dysfunction (ED).
- ClinicalTrials.gov ID
- NCT01110590
- Acronym / sponsor ID
- 14612
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 26 Apr 2010 (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.
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552 and vardenafil will be given with patients with erectile dysfunction.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BAY60-4552 + Vardenafil |
| Arm 2 | Experimental | Drug: BAY60-4552 + Vardenafil |
| Arm 3 | Experimental | Drug: BAY60-4552 + Vardenafil |
| Arm 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The informed consent must be signed before any study specific tests or procedures are done
- Male patients with a history of erectile dysfunction (ED) for at least 6 months, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse" by the NIH consensus report 1993. The diagnosis of 'Erectile dysfunction' has to be confirmed by a physician
- Age: 18 to 70 years (inclusive) at the first screening examination
- Ethnicity: White
- Body mass index (BMI): equal to or above 18 and below 32 kg / m²
Key exclusion criteria (10 listed)
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity according to the NIH consensus report 1993
- History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to screening
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 |
|---|---|---|
| BAY60-4552 + VardenafilTotal dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil | Drug | Arm 1 |
| BAY60-4552 + VardenafilTotal dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil | Drug | Arm 2 |
| BAY60-4552 + VardenafilTotal dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil | Drug | Arm 3 |
| PlaceboPlacebo | Drug | Arm 4 |
Primary outcome
Adverse Event reporting
Time frame: up to 6 weeks
2 secondary outcomes
Plasma concentration of study drugs; Pharmacokinetic parameters: AUC, Cmax, AUC/D, Cmax;norm, Cmax/D, t1/2, tmax
Time frame: Day 0, 6, 13
Plasma concentration of cyclic guanosine monophosphate (cGMP)
Time frame: Day 0, 6, 13
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 22 Feb 2013.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY60-4552 + Vardenafil in people with Erectile Dysfunction, run by Bayer at 1 site in Germany.
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 7 inclusion and 10 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 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse Event reporting (time frame: up to 6 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 22 Feb 2013.