Status:
COMPLETED
Interaction Between Fluvoxamine and Sildenafil
Lead Sponsor:
Heidelberg University
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its effect on the venous response to sodium nitroprusside.
Detailed Description
In a randomised, double-blind, placebo-controlled, cross-over study in healthy men we will assess the effect of oral fluvoxamine (50mg qd on day 1-3; 100mg qd on day 4-10) on sildenafil kinetics (sing...
Eligibility Criteria
Inclusion
- Healthy, male individuals, age: 18-45.
- Able and willing to give written informed consent
Exclusion
- Hypotension ( 65 mmHg diastolic and 100 mmHg systolic blood pressure)
- Bleeding disorders in medical history
- Intake of medication impairing platelet function or influencing coagulation (for example aspirin, NSAID and others) during the preceding 4 weeks
- Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, hyperhomocysteinaemia, smoking)
- Anatomic deformity of the penis like angulation, penile fibromatosis (peyronie's disease) or diseases favouring priapism (e.g. leukaemia, plasmocytoma, sickle-cell anaemia)
- Regular medication and/or treatment with drugs within the preceding 4-6 weeks (exclusion has to be decided in each case)
- alcohol (\>30 g/d) or drug abuse
- Acute or chronic illness
- Blood donation within the preceding 2 months
- Participation in clinical trial within 2 month before the study
- Drug and/or alcohol abuse.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00175981
Start Date
February 1 2003
End Date
November 1 2004
Last Update
September 15 2005
Active Locations (1)
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1
Dept. of Internal Medicine VI, University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120