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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00661219 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction Depression |
Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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. |
| Enrollment: | 267 |
| Study Start Date: | December 2002 |
| Study Completion Date: | November 2003 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Arm 1 |
Drug: Levitra (Vardenafil, BAY38-9456)
BAY 38-9456 (vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.
|
| Placebo Comparator: Arm 2 |
Drug: Placebo
Identical placebo will be matched for each vardenafil dosage form and will be indistinguishable from active treatment.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Previous or Current Medical Conditions
Abnormal Laboratory Values
Abnormal Laboratory Values
Other Exclusions
Contacts and Locations
Show 52 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT00661219 History of Changes |
| Other Study ID Numbers: | 10621 |
| Study First Received: | April 15, 2008 |
| Last Updated: | June 19, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Depression Depressive Disorder Erectile Dysfunction Behavioral Symptoms Mood Disorders Mental Disorders Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders |
Vardenafil Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |