Erectile DysfunctionNCT00874679
REPEAT - Real-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra Therapy
An observational study of Erectile Dysfunction, run by Bayer at 15 sites in 15 countries.
Trial summary
The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. Furthermore, the data collection particularly focuses on the experience of the patient and his satisfaction with the treatment. 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)
- How many people
- 7,293 participants
- Where
- 15 sitesin 15 countries
- Study dates
- Mar 2007to Apr 2010
- Phase
- Observational
- 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
Study population: Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment
Who may be able to join
- Outpatients with diagnosis of erectile dysfunction, decision taken by the investigator to prescribe Vardenafil.
Who cannot join
- Exclusion criteria must be read in conjunction with the local product information. All contraindications listed in the local product information are applicable.
Trial locations and contacts
15 sites in 15 countries.
15 sites in 15 countries
About this study
Official title: REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy
The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. Furthermore, the data collection particularly focuses on the experience of the patient and his satisfaction with the treatment. Treatment naive patients as well as pre-treated patients will be included in the study.The maximum observation period per patient is 12 months.Besides the physician's documentation, the patient should fill out a questionnaire at every visit. The questionnaires will be handed out and collected by the physician. Furthermore, an additional questionnaire for the patient's partner can be distributed at each visit in case the partner is willing to participate.
- Conditions
- Erectile Dysfunction
- Being tested
- Levitra (Vardenafil, BAY38-9456)
- 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
Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 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.
Physician's assessment of safety (incidence of adverse events)
Measured: During observation period
Secondary outcomes (3)
Severity of ED symptoms
Measured: End of study
General quality of partnership as assessed by patient
Measured: Initial visit and after 3, 6, 9 and 12 months
General quality of partnership as assessed by partner
Measured: Initial visit and after 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startMar 2007
- Primary completionApr 2010
- Study completionApr 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,293 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
- NCT00874679
- Sponsor's protocol ID
- 12805
- Other IDs
- REPEAT, LV0602, 12942 - LV0602KR, 12975 - LV0602HR, 12976 - LV0602CN, 12977 - LV0602SG, 13047 - LV0602SE, 13048 - LV0602ZA
- Status last verified
- Nov 2011
- First submitted
- 1 Apr 2009
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy
- ClinicalTrials.gov ID
- NCT00874679
- Acronym / sponsor ID
- 12805
- Conditions
- Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,293 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 2 Apr 2009 (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.
The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. Furthermore, the data collection particularly focuses on the experience of the patient and his satisfaction with the treatment. Treatment naive patients as well as pre-treated patients will be included in the study.The maximum observation period per patient is 12 months.Besides the physician's documentation, the patient should fill out a questionnaire at every visit. The questionnaires will be handed out and collected by the physician. Furthermore, an additional questionnaire for the patient's partner can be distributed at each visit in case the partner is willing to participate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | 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
- Study population
- Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment
Key inclusion criteria (1 listed)
- Outpatients with diagnosis of erectile dysfunction, decision taken by the investigator to prescribe Vardenafil.
Key exclusion criteria (1 listed)
- Exclusion criteria must be read in conjunction with the local product information. All contraindications listed in the local product information are applicable.
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 with diagnosis of erectile dysfunction who get vardenafil in routine treatment | Drug | Group 1 |
Primary outcome
Physician's assessment of safety (incidence of adverse events)
Time frame: During observation period
3 secondary outcomes
Severity of ED symptoms
Time frame: End of study
General quality of partnership as assessed by patient
Time frame: Initial visit and after 3, 6, 9 and 12 months
General quality of partnership as assessed by partner
Time frame: Initial visit and after 3, 6, 9 and 12 months
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 11 Nov 2011.
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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
15 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Bayer at 15 sites in 15 countries.
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 1 inclusion and 1 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 11 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China, Croatia, France, Germany, Hungary and 10 more countries. 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.
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?
Physician's assessment of safety (incidence of adverse events) (time frame: During observation period). 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 11 Nov 2011.