NCT02620995

Brief Summary

The study will evaluate the effects of a chronic 30-day treatment with sildenafil citrate on penile and systemic microvascular function as well as in blood pressure. A control group of normotensive age-matched healthy subjects will serve as a comparator group for normal penile and systemic microvascular function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2014

Typical duration for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

December 1, 2015

Last Update Submit

March 5, 2018

Conditions

Arterial HypertensionErectile Dysfunction

Keywords

hypertensionendothelial dysfunctionerectile dysfunctionsildenafil

Outcome Measures

Primary Outcomes (1)

  • Penile microvascular vasodilatory capacity

    at the end of a 30-day treatment

Secondary Outcomes (1)

  • Blood pressure levels evaluated using ambulatory blood pressure monitoring

    at the end of a 30-day treatment

Study Arms (2)

hypertensive patients

EXPERIMENTAL

Hypertensive patients will receive a single oral dose of sildenafil citrate (100 mg) - acute protocol - and a chronic 30-day treatment with sildenafil citrate (50 mg twice daily) - chronic protocol. Penile and systemic microvascular function will be evaluated before and one hour after acute sildenafil administration and in the end of each treatment period.

Drug: sildenafil citrate

comparator group

SHAM COMPARATOR

Normotensive individuals age-matched to the hypertensive patients will receive only a single dose of sildenafil citrate (100 mg) - acute protocol. Penile and systemic microvascular function will be evaluated before and one hour after sildenafil administration.

Other: comparator group

Interventions

sildenafil citrateDRUG

the hypertensive patients with erectile dysfunction will be treated with sildenafil citrate (100 mg daily) or placebo (crossover design)

Also known as: Viagra
hypertensive patients
comparator groupOTHER

Normotensive individuals age-matched to the hypertensive patients will receive only a single dose of sildenafil citrate (100 mg) - acute protocol. Penile and systemic microvascular function will be evaluated before and one hour after sildenafil administration.

comparator group

Eligibility Criteria

Age50 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • arterial hypertension stage I or II
  • erectile dysfunction (vasculogenic)

You may not qualify if:

  • diabetes
  • kidney, liver, neurologic and psychiatric diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, 22240-006, Brazil

Location

MeSH Terms

Conditions

HypertensionErectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Eduardo V Tibirica, MD, PhD

    National Institute of Cardiology - Ministry of Health -Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 3, 2015

Study Start

October 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

BR(1)