Interaction Between Fluvoxamine and Sildenafil

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its effect on the venous response to sodium nitroprusside.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Heidelberg University
• Treatments: Fluvoxamine; Sildenafil Citrate

Criteria

Inclusion Criteria:

• Healthy, male individuals, age: 18-45.

• Able and willing to give written informed consent

Exclusion Criteria:

• 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.