Interaction Between Fluvoxamine and Sildenafil | NCT00175981

Studies
Interaction Between Fluvoxamine and Sildenafil

NCT00175981

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Sep 15, 2005Estimated

Enrollment

Phase

Phase 1

Conditions

Healthy

Interventions

sildenafil, fluvoxamine

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Not provided

Completion Date

Nov 2004

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2005

Last Update Posted Date

Sep 15, 2005Estimated

Description Module

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 (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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
sildenafil, fluvoxamine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Drug-induced changes of hand vein compliance
Drug-induced changes of pharmacokinetic parameters

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Walter E Haefeli, MD	Heidelberg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Internal Medicine VI, University of Heidelberg		Heidelberg	Baden-Wurttemberg	69120	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D000068677	Sildenafil Citrate
D016666	Fluvoxamine

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457

Browse Leaves

Not provided

Browse Branches

Not provided