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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
280
BAY 38-9456 (vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.
Identical placebo will be matched for each vardenafil dosage form and will be indistinguishable from active treatment.
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Huntsville, Alabama, United States
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Anchorage, Alaska, United States
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Beverly Hills, California, United States
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Irvine, California, United States
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La Mesa, California, United States
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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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
San Diego, California, United States
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Aventura, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
Unnamed facility
Boston, Massachusetts, United States
...and 42 more locations