Erectile DysfunctionPhase 3DRIVERNCT00661219
Depression Related Improvement With Vardenafil for Erectile Response
A Phase 3 study testing Levitra (Vardenafil, BAY38-9456) in people with Erectile Dysfunction and Depression, run by Bayer at 52 sites in 5 countries.
Trial summary
The study will last three months. During the first month of treatment the subject will receive either 10 mg vardenafil or placebo. After 1 month of treatment the doctor, can choose to increase the dosage from 10 mg to 20 mg or decrease the dosage to 5 mg. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Depression
- 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
- 280 participants
- Where
- 52 sitesin 5 countries
- Study dates
- Dec 2002to Nov 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Erectile dysfunction for more than 6 months according to the NIH Consensus statement (the inability to attain and maintain erection of the penis sufficient to permit satisfactory sexual intercourse).
- Stable, heterosexual relationship for more than 6 months.
- Diagnosis of mild Major Depressive Disorder using a structured interview (SCID-1 or MINI), according to DSM-IV criteria. Before randomization, a psychiatrist must interview the subject at Visit 2 to validate both the diagnosis of MDD and the subject's continuation in the study without the need for anti-depressant medication or psychotherapy).
- Patients must score greater than 13 on the CES-D at Visit 1.
- Patients must score between 11 and 17 on the 17-item HAM-D at Visit 1 and Visit 2.
- The patient must make at least four attempts at sexual intercourse on four separate days during the untreated baseline period
- At least 50% of the attempts of sexual intercourse during the untreated baseline period have to be unsuccessful
Who cannot join
- Previous or Current Medical Conditions
- Any unstable medical condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study.
- Patients who score > 0 on item #3 on the HAM-D17 or men who, in the investigator's judgement, pose a current serious suicidal or homicidal risk or have made a suicide attempt within the past 12 months.
- Men with a current (or within 6 months prior to screening) Axis 1 disorder other than MDD (major depressive disorder). Patients with a history, or who currently meet the DSM-IV criteria, of Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Delusional (Paranoid) Disorder, Panic Disorder, Post-Traumatic Stress Disorder. Patients with a Personality Disorder are excluded if, in the investigator's opinion, it will interfere with the conduct of the trial.
- Retinitis pigmentosa.
- Unstable angina pectoris.
Show all 22Show fewer
- History of radical prostatectomy.
- History of myocardial infarction, stroke, electrocardiographic ischemia (except stable angina), or life-threatening arrhythmia within the prior 6 months.
- Abnormal Laboratory Values
- AST or ALT > 3 times the upper limit of normal Concomitant Medications
- Patients who are taking nitrates or nitric oxide donors (e.g., molsidomine, minoxidil). Topical minoxidil is permitted.
- Patients who are taking androgens (e.g., testosterone) or anti-androgens.
- Patients taking trazodone, or any other anti-depressant including monoamine oxidase inhibitors, St. John's Wort, SSRIs or tricyclic anti-depressants are excluded, or use of these medications in the last 2 weeks before Visit 1. Fluoxetine is excluded in the last 4 weeks before Visit 1.
- Patients who are taking the following potent inhibitors of cytochrome P 450 3A4: the HIV protease inhibitors ritonavir and indinavir, erythromycin or the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed).
- Subjects who are taking alpha-blockers.
- Use of any therapy for erectile dysfunction within seven days of Visit 1 and during the trial.
- Patients who require, or are likely to require, treatment with psychotherapy or psychotropic drugs during the course of the study. Men receiving formal individual psychotherapy for depression currently or in the 12 weeks prior to screening visit.
- Abnormal Laboratory Values
- Patients who have a serum total testosterone level >10% below the lower limit of normal (according to the range specified by the responsible laboratory).
- Other Exclusions
- Patients whose urine screen for substances of abuse is positive.
- Patients unwilling to refrain from consuming grapefruit juice or products containing grapefruit juice with study medication.
Trial locations and contacts
52 sites in 5 countries.
52 sites in 5 countries
United States15 sites
Study site
Albuquerque, New Mexico, 87131
Study site
Anchorage, Alaska, 99508
Study site
Atlanta, Georgia, 30308
Study site
Atlanta, Georgia, 30339
Study site
Aventura, Florida, 33180
Study site
Beverly Hills, California, 90212
Study site
Boston, Massachusetts, 02118
Study site
Charlottesville, Virginia, 22908
Study site
Durham, North Carolina, 27710
Study site
Huntsville, Alabama, 35801
Study site
Irvine, California, 92618-3603
Study site
La Mesa, California, 91942-3058
Study site
New Brunswick, New Jersey, 08901
Study site
New York, New York, 10032
Study site
San Diego, California, 92101
Canada12 sites
Study site
Calgary, Alberta, T2S 0J2
Study site
Edmonton, Alberta, T5K 2K5
Study site
Hamilton, Ontario, L8M 1K7
Study site
Hull, Quebec, J9A 1K7
Study site
Markham, Ontario, L6B 1A1
Study site
Montreal, Quebec, H2X 1N8
Study site
Montreal, Quebec, H3G 1A4
Study site
Ottawa, Ontario, K1G 4G3
Study site
Pointe-Claire, Quebec, H9R 4S3
Study site
Sherbrooke, Quebec, JIH 4J6
Study site
Toronto, Ontario, M9W 4L6
Study site
Vancouver, British Columbia, V5Z 1M9
France10 sites
Study site
Lille, 59000
Study site
Lyon, 69000
Study site
Lyon, 69007
Study site
Lyon, 69437
Study site
Marseille, 13006
Study site
Marseille, 13008
Study site
Marseille, 13275
Study site
Nantes, 44000
Study site
Nice, 06200
Study site
Paris, 75009
Italy10 sites
Study site
Bari, 70124
Study site
Florence, 50139
Study site
Milan, 20122
Study site
Milan, 20123
Study site
Milan, 20132
Study site
Modena, 41100
Study site
Naples, 80131
Study site
Padova, 35128
Study site
Pisa, 56126
Study site
Roma, 00155
Spain5 sites
Study site
Barcelona, Barcelona, 08036
Study site
Galdakao, Bizkaia, 48960
Study site
Madrid, Madrid, 28007
Study site
Seville, Sevilla, 41013
Study site
Zaragoza, Zaragoza, 50009
About this study
Official title: A Randomized Double-blind Multi-center Parallel Group Three Month Study to Compare the Tolerability and Efficacy of Flexible Dose Vardenafil Versus Placebo in Men With Depression and Erectile Dysfunction.
The study will last three months. During the first month of treatment the subject will receive either 10 mg vardenafil or placebo. After 1 month of treatment the doctor, can choose to increase the dosage from 10 mg to 20 mg or decrease the dosage to 5 mg. The doctor will again evaluate, after 2 months of treatment if the subject wants to increase the dosage from 10 mg to 20 mg or, if already done, to continue with the dosage of 20 mg or decrease to 10 mg or 5 mg. It will not be possible after this point to increase or decrease the dosage for the rest of the study. The subject will be asked to attend the clinic on four separate occasions over a period of 3 months. Every visit will last about 1 hour. At the first visit the doctor will ask the subject about their medical history, and the subject will be given a medical examination (including your heart rate, blood pressure and weight). The medical examination will also include an ECG. The subject will be asked to provide a blood and urine sample, which will be analysed and screened for drugs of potential abuse (e.g.cocaine, narcotics, sedatives, hypnotics). The subject will then be asked to fill in a questionnaire about their mood and feelings. The subject qualifies, they will have an interview with a trained mental health care provider who will assess their level of depression. At the end of the visit, the doctor will provide the subject with a diary in which they must record details about their attempts at sexual activity during the next 4 weeks. The subject will be asked to make at least 4 attempts at sexual intercourse on 4 separate days and to record the attempts in the diaries. After 4 weeks the subject will return to the clinic. They will be asked to fill in different questionnaires about their sexuality, mood and feelings, general quality of life, self-esteem and sexual activity in the last 4 weeks. Two additional blood and urine samples will be collected. An interview with the trained mental health care provider who will re-assess their level of depression. At this visit all information collected so far will be assessed and the doctor will check to see if the requirements to enter the treatment period are fulfilled. The subject may be excluded from further participation in the study, for example due to results of the blood analysis or if your level of depression did not meet the criteria for the study. If the subject is able to participate to the study they will be given the study drug. At each visit, adverse events will be discussed and whether there is any change in medicine. Vital signs and ECG will be obtained at visit one, two, five and/or Premature Termination. At every visit the subject will receive a diary in which they must record details about their attempts at sexual activity during the period between each visit and the number of tablets taken. Subjects will also be asked to fill in different questionnaires about their sexuality, mood and feelings, self-esteem and sexual activity. Subjects will also be contacted by telephone, at 2, 6 and 10 weeks after starting the study medication, 24 hours after the last dose of study medication. The doctor will give the study drug on 3 occasions. Should the subject or doctor prematurely stop trial participation the subject will be required to return to the clinic for a physical examination, vital signs and have blood samples and ECG obtained. They will also be asked to fill in different questionnaires.
- Conditions
- Erectile Dysfunction, Depression
- Being tested
- Levitra (Vardenafil, BAY38-9456), Placebo
- Medical subject headings
- Erectile Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levitra (Vardenafil, BAY38-9456)Drug
BAY 38-9456 (vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.
PlaceboDrug
Identical placebo will be matched for each vardenafil dosage form and will be indistinguishable from active treatment.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | 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.
The primary efficacy variables are the change from baseline in the IIEF-EF domain score and the change from baseline in the HAM-D17 total score.
Measured: 12 weeks and LOCF
Secondary outcomes (9)
Patient Diary questions of treatment compared to placebo.
Measured: 4, 8, and 12 weeks
Global assessment question (GAQ) of treatment compared to placebo.
Measured: 12 weeks
The scores for the IIEF questionnaire.
Measured: 12 weeks
Responses on the Center for Epidemiologic Studies Depression Scale (CES-D).
Measured: 12 weeks
Responses on the Rosenberg Self Esteem Scale.
Measured: 12 weeks
Responses on the Clinical Global Impressions scale, Items 1 and 2.
Measured: 12 weeks
Reliability in early responders.
Measured: 12 weeks
Other IIEF domain scores than EF domain score at 12 weeks.
Measured: 12 weeks
Safety assessment
Measured: Throughout study
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 startDec 2002
- Primary completionNov 2003
- Study completionNov 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
- 280 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
- NCT00661219
- Sponsor's protocol ID
- 10621
- Acronym
- DRIVER
- Status last verified
- Dec 2014
- First submitted
- 15 Apr 2008
- Last updated
- 23 Dec 2014
- Results posted
- 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
- A Randomized Double-blind Multi-center Parallel Group Three Month Study to Compare the Tolerability and Efficacy of Flexible Dose Vardenafil Versus Placebo in Men With Depression and Erectile Dysfunction.
- ClinicalTrials.gov ID
- NCT00661219
- Acronym / sponsor ID
- DRIVER / 10621
- Conditions
- Erectile Dysfunction, Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2003 (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.
The study will last three months. During the first month of treatment the subject will receive either 10 mg vardenafil or placebo. After 1 month of treatment the doctor, can choose to increase the dosage from 10 mg to 20 mg or decrease the dosage to 5 mg. The doctor will again evaluate, after 2 months of treatment if the subject wants to increase the dosage from 10 mg to 20 mg or, if already done, to continue with the dosage of 20 mg or decrease to 10 mg or 5 mg. It will not be possible after this point to increase or decrease the dosage for the rest of the study. The subject will be asked to attend the clinic on four separate occasions over a period of 3 months. Every visit will last about 1 hour. At the first visit the doctor will ask the subject about their medical history, and the subject will be given a medical examination (including your heart rate, blood pressure and weight). The medical examination will also include an ECG. The subject will be asked to provide a blood and urine sample, which will be analysed and screened for drugs of potential abuse (e.g.cocaine, narcotics, sedatives, hypnotics). The subject will then be asked to fill in a questionnaire about their mood and feelings. The subject qualifies, they will have an interview with a trained mental health care provider who will assess their level of depression. At the end of the visit, the doctor will provide the subject with a diary in which they must record details about their attempts at sexual activity during the next 4 weeks. The subject will be asked to make at least 4 attempts at sexual intercourse on 4 separate days and to record the attempts in the diaries. After 4 weeks the subject will return to the clinic. They will be asked to fill in different questionnaires about their sexuality, mood and feelings, general quality of life, self-esteem and sexual activity in the last 4 weeks. Two additional blood and urine samples will be collected. An interview with the trained mental health care provider who will re-assess their level of depression. At this visit all information collected so far will be assessed and the doctor will check to see if the requirements to enter the treatment period are fulfilled. The subject may be excluded from further participation in the study, for example due to results of the blood analysis or if your level of depression did not meet the criteria for the study. If the subject is able to participate to the study they will be given the study drug. At each visit, adverse events will be discussed and whether there is any change in medicine. Vital signs and ECG will be obtained at visit one, two, five and/or Premature Termination. At every visit the subject will receive a diary in which they must record details about their attempts at sexual activity during the period between each visit and the number of tablets taken. Subjects will also be asked to fill in different questionnaires about their sexuality, mood and feelings, self-esteem and sexual activity. Subjects will also be contacted by telephone, at 2, 6 and 10 weeks after starting the study medication, 24 hours after the last dose of study medication. The doctor will give the study drug on 3 occasions. Should the subject or doctor prematurely stop trial participation the subject will be required to return to the clinic for a physical examination, vital signs and have blood samples and ECG obtained. They will also be asked to fill in different questionnaires.
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 | Active comparator | Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Erectile dysfunction for more than 6 months according to the NIH Consensus statement (the inability to attain and maintain erection of the penis sufficient to permit satisfactory sexual intercourse).
- Stable, heterosexual relationship for more than 6 months.
- Diagnosis of mild Major Depressive Disorder using a structured interview (SCID-1 or MINI), according to DSM-IV criteria. Before randomization, a psychiatrist must interview the subject at Visit 2 to validate both the diagnosis of MDD and the subject's continuation in the study without the need for anti-depressant medication or psychotherapy).
- Patients must score greater than 13 on the CES-D at Visit 1.
- Patients must score between 11 and 17 on the 17-item HAM-D at Visit 1 and Visit 2.
Key exclusion criteria (22 listed)
- Previous or Current Medical Conditions
- Any unstable medical condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study.
- Patients who score > 0 on item #3 on the HAM-D17 or men who, in the investigator's judgement, pose a current serious suicidal or homicidal risk or have made a suicide attempt within the past 12 months.
- Men with a current (or within 6 months prior to screening) Axis 1 disorder other than MDD (major depressive disorder). Patients with a history, or who currently meet the DSM-IV criteria, of Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Delusional (Paranoid) Disorder, Panic Disorder, Post-Traumatic Stress Disorder. Patients with a Personality Disorder are excluded if, in the investigator's opinion, it will interfere with the conduct of the trial.
- Retinitis pigmentosa.
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)BAY 38-9456 (vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets. | Drug | Arm 1 |
| PlaceboIdentical placebo will be matched for each vardenafil dosage form and will be indistinguishable from active treatment. | Drug | Arm 2 |
Primary outcome
The primary efficacy variables are the change from baseline in the IIEF-EF domain score and the change from baseline in the HAM-D17 total score.
Time frame: 12 weeks and LOCF
9 secondary outcomes
Patient Diary questions of treatment compared to placebo.
Time frame: 4, 8, and 12 weeks
Global assessment question (GAQ) of treatment compared to placebo.
Time frame: 12 weeks
The scores for the IIEF questionnaire.
Time frame: 12 weeks
Responses on the Center for Epidemiologic Studies Depression Scale (CES-D).
Time frame: 12 weeks
Responses on the Rosenberg Self Esteem Scale.
Time frame: 12 weeks
Responses on the Clinical Global Impressions scale, Items 1 and 2.
Time frame: 12 weeks
Reliability in early responders.
Time frame: 12 weeks
Other IIEF domain scores than EF domain score at 12 weeks.
Time frame: 12 weeks
Safety assessment
Time frame: Throughout 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
52 sites in 5 countries: 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 Depression, run by Bayer at 52 sites in 5 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 7 inclusion and 22 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 52 sites in United States, Canada, France, Italy, Spain. 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?
The primary efficacy variables are the change from baseline in the IIEF-EF domain score and the change from baseline in the HAM-D17 total score. (time frame: 12 weeks and LOCF). 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.