Trial Condition(s):

Erectile Dysfunction, Depression

Depression Related Improvement with Vardenafil for Erectile Response (DRIVER)

Bayer Identifier:

10621

ClinicalTrials.gov Identifier:

NCT00661219

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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
Exclusion Criteria
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.
- 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 Summary

Enrollment Goal
280
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Zaragoza, Spain, 50009

Status
Completed
 
Locations

Investigative Site

LYON, France, 69000

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20132

Status
Completed
 
Locations

Investigative Site

Vancouver, Canada, V5Z 1C6

Status
Completed
 
Locations

Investigative Site

LYON CEDEX, France, 69437

Status
Completed
 
Locations

Investigative Site

Markham, Canada, L6B 1A1

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20122

Status
Completed
 
Locations

Investigative Site

NICE, France, 06200

Status
Completed
 
Locations

Investigative Site

Bari, Italy, 70124

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M9W 4L6

Status
Completed
 
Locations

Investigative Site

MARSEILLE, France, 13008

Status
Completed
 
Locations

Investigative Site

Firenze, Italy, 50139

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20123

Status
Completed
 
Locations

Investigative Site

Beverly Hills, United States, 90212

Status
Completed
 
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Investigative Site

Sherbrooke, Canada, JIH 4J6

Status
Completed
 
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Investigative Site

Montreal, Canada, H2X 1N8

Status
Completed
 
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Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
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Investigative Site

Padova, Italy, 35128

Status
Completed
 
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Investigative Site

Aventura, United States, 33180

Status
Completed
 
Locations

Investigative Site

LYON, France, 69007

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02118

Status
Completed
 
Locations

Investigative Site

Hamilton, Canada, L8M 1K7

Status
Completed
 
Locations

Investigative Site

Sevilla, Spain, 41013

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28007

Status
Completed
 
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Investigative Site

Roma, Italy, 00161

Status
Completed
 
Locations

Investigative Site

Huntsville, United States, 35801

Status
Completed
 
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Investigative Site

Hull, Canada, J9A 1K8

Status
Completed
 
Locations

Investigative Site

Irvine, United States, 92618-3603

Status
Completed
 
Locations

Investigative Site

Ottawa, Canada, K1G 4G3

Status
Completed
 
Locations

Investigative Site

New York, United States, 10032-3713

Status
Completed
 
Locations

Investigative Site

Charlottesville, United States, 22903-9353

Status
Completed
 
Locations

Investigative Site

San Diego, United States, 92101

Status
Completed
 
Locations

Investigative Site

MARSEILLE, France, 13006

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H3G 1A4

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75009

Status
Completed
 
Locations

Investigative Site

Napoli, Italy, 80131

Status
Completed
 
Locations

Investigative Site

New Brunswick, United States, 08903-0019

Status
Completed
 
Locations

Investigative Site

MARSEILLE, France, 13275

Status
Completed
 
Locations

Investigative Site

Modena, Italy, 41100

Status
Completed
 
Locations

Investigative Site

LILLE, France, 59000

Status
Completed
 
Locations

Investigative Site

Pisa, Italy, 56124

Status
Completed
 
Locations

Investigative Site

Edmonton, Canada, T5K 2K5

Status
Completed
 
Locations

Investigative Site

NANTES, France, 44000

Status
Completed
 
Locations

Investigative Site

Anchorage, United States, 99508

Status
Completed
 
Locations

Investigative Site

La Mesa, United States, 91942-3058

Status
Completed
 
Locations

Investigative Site

Atlanta, United States, 30308

Status
Completed
 

Trial Design