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Phosphodiesterase-5 Inhibitor

Sildenafil for Pulmonary Circulation in Healthy Individuals

Phase 2

Recruiting

Led By Michael K Stickland, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All participants between the ages of 18-40 years

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up minimum of 30 minutes post-dose.

Awards & highlights

Study Summary

This trial is testing whether sildenafil, a medication that improves blood flow, can also improve lung function in people who have been aerobic training. The study will compare the effects of sildenafil in trained and untrained participants.

Who is the study for?

This trial is for healthy adults aged 18-40. Untrained participants should have a peak oxygen uptake (V̇O2peak) of 30-45 ml.kg-1.min-1, while trained ones must exceed 55 or 60 ml.kg-1.min-1 for females and males respectively. Exclusions include pre-existing heart conditions, pulmonary hypertension, current prescription drug use (except oral contraceptives), pregnancy, lactation, and inability to exercise.Check my eligibility

What is being tested?

The study tests the effects of Sildenafil on lung circulation in both physically trained and untrained individuals by comparing it with a placebo. It aims to determine if this medication can improve markers like capillary blood volume and gas exchange efficiency during rest and exercise.See study design

What are the potential side effects?

While not specified here, common side effects of Sildenafil may include headaches, flushing, indigestion, nasal congestion, dizziness after standing up quickly due to low blood pressure (orthostatic hypotension), and visual disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 40 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ minimum of 30 minutes post-dose.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~minimum of 30 minutes post-dose.

This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum of 30 minutes post-dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Capillary blood volume (Vc)

Diffusion capacity of carbon monoxide (DLCO)

Membrane diffusing capacity (Dm)

Secondary outcome measures

Pulmonary artery systolic pressure (PASP)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Healthy, UntrainedExperimental Treatment2 Interventions

Untrained participants will be defined as having a V̇O2peak of 30-45 ml.kg-1.min-1 and will be between 18-40 years of age.

Group II: Healthy, TrainedExperimental Treatment2 Interventions

Trained participants will be defined as having a V̇O2peak above 55 ml.kg-1.min-1 (females) and 60 ml.kg-1.min-1 (males) and will be between 18-40 years of age.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sildenafil 50 mg

2020

Completed Phase 4

~410

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

888 Previous Clinical Trials

384,898 Total Patients Enrolled

Michael K Stickland, PhDPrincipal InvestigatorUniversity of Alberta

9 Previous Clinical Trials

4,483 Total Patients Enrolled

Sean van Diepen, MDStudy DirectorUniversity of Alberta

2 Previous Clinical Trials

9,150 Total Patients Enrolled

Media Library

Sildenafil (Phosphodiesterase-5 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04985929 — Phase 2

Healthy Subjects Research Study Groups: Healthy, Untrained, Healthy, Trained

Healthy Subjects Clinical Trial 2023: Sildenafil Highlights & Side Effects. Trial Name: NCT04985929 — Phase 2

Sildenafil (Phosphodiesterase-5 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04985929 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings at present for prospective participants in this research?

"Affirmative. According to the data shared on clinicaltrials.gov, this medical trial is presently recruiting participants; it was initially posted at July 1st 2021 and modified on September 19th 2022. This study requires 60 volunteers across a single site."

Answered by AI

What therapeutic applications is Sildenafil 50 mg typically employed for?

"Sildenafil 50 mg can be utilized to treat premature ejaculation, NYHA functional class II-III pulmonary arterial hypertension (PAH), and PAH."

Answered by AI

How many individuals have been recruited to partake in this clinical investigation?

"Confirmed. Clinicaltrials.gov reveals that this clinical trial, which was launched on July 1st 2021 and last revised on September 19th 2022, is actively enrolling patients. Approximately 60 participants are needed from one medical facility."

Answered by AI

What potential adverse reactions should recipients consider when taking Sildenafil 50 mg?

"The safety of Sildenafil 50 mg was assessed as a 2 due to its Phase 2 status, indicating there is some evidence surrounding the drug's security but nothing yet proving its efficacy."

Answered by AI

What are the eligibility criteria for participation in this trial?

"This medical trial is currently recruiting 60 suitable candidates aged 18-40, who have a V̇O2peak of 30-45 ml.kg-1.min-1 and are deemed to be healthy subjects (hs)."

Answered by AI