NCT00710099

Brief Summary

Iontophoresis is a employed to facilitate drug absorption without systemic effect. This study investigates cutaneous microcirculation when we associate sildenafil per os with SNP via iontophoresis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

2.9 years

First QC Date

July 2, 2008

Last Update Submit

October 5, 2011

Conditions

Healthy

Keywords

iontophoresiscutaneous microcirculationsildenafilHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • variation of conductance of nitroprussiate iontophoresis associated with oral sildenafil

    one hour

Secondary Outcomes (1)

  • To assess the effect of oral sildenafil (50 mg and 100 mg) on skin microvascular reactivity to local cooling, on the forearm and the finger

    one hour

Study Arms (2)

1

EXPERIMENTAL
Drug: sildenafil

2

ACTIVE COMPARATOR

SNP iontophoresis

Drug: nitroprussiate iontophoresis

Interventions

sildenafilDRUG

systemic absorption of sildenafil

1
nitroprussiate iontophoresisDRUG

nitroprussiate iontophoresis

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18
  • No significant medical history

You may not qualify if:

  • Age under 18
  • Pregnancy
  • Breast feeding
  • Severe disease
  • Cigarette smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Researsh Centre

Grenoble, Isere, 38043, France

Location

Related Publications (1)

  • Cracowski JL, Minson CT, Salvat-Melis M, Halliwill JR. Methodological issues in the assessment of skin microvascular endothelial function in humans. Trends Pharmacol Sci. 2006 Sep;27(9):503-8. doi: 10.1016/j.tips.2006.07.008. Epub 2006 Jul 31.

    PMID: 16876881BACKGROUND

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jean-Luc CRACOWSKI, MD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 4, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

FR(1)