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Interaction Between Fluvoxamine and Sildenafil

H

Heidelberg University

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: sildenafil, fluvoxamine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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 (single oral 50mg dose on day 11). Sildenafil plasma concentrations will be determined by LC/MS. We will also assess the effect of sildenafil on venodilation induced by a constant dose-rate of the NO-donor sodium nitroprusside (SNP) during preconstriction with phenylephrine (dorsal hand vein compliance technique).

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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