Depression Related Improvement With Vardenafil for Erectile Response
Status:
Completed
Trial end date:
2003-11-01
Target enrollment:
Participant gender:
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. 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.