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Hormone Therapy
Oxytocin Administration in Healthy Volunteers
Phase 1
Waitlist Available
Led By James C Eisenach, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 minute after intranasal oxytocin administration
Awards & highlights
No Placebo-Only Group
Summary
This trial studies the concentrations of oxytocin in the blood of people receiving an infusion and a dose of oxytocin to model the pharmacokinetics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 minute after intranasal oxytocin administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 minute after intranasal oxytocin administration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Plasma Oxytocin Concentration 1 Minute After First Intranasal Puffs
Plasma Oxytocin Concentration 10 Minutes After First Intranasal Puffs
Plasma Oxytocin Concentration 10 Minutes After Infusion Initiated
+18 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Oxytocin Administration (Intravenous, then Intranasal)Experimental Treatment2 Interventions
Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
intranasal oxytocin
2017
Completed Phase 1
~380
intravenous oxytocin
2023
Completed Phase 1
~200
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,397 Previous Clinical Trials
2,460,104 Total Patients Enrolled
2 Trials studying Healthy Volunteer Study
45 Patients Enrolled for Healthy Volunteer Study
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,381 Previous Clinical Trials
652,275 Total Patients Enrolled
James C Eisenach, MDPrincipal InvestigatorWake Forest University Health Sciences
17 Previous Clinical Trials
781 Total Patients Enrolled
2 Trials studying Healthy Volunteer Study
45 Patients Enrolled for Healthy Volunteer Study
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You should not use nasal products like saline spray or intranasal corticosteroids during the study.You have nerve problems, chronic pain that requires daily treatment, diabetes, or regularly take certain medications for pain or anxiety.You have an allergy to latex.You have a strong allergic reaction or sensitivity to any ingredient in Pitocin®.Your body mass index (BMI) should be less than 40.You have had low sodium levels in the past or are at risk of having low sodium levels. You are taking certain medications like diuretics, lithium, or antidepressants.
Research Study Groups:
This trial has the following groups:- Group 1: Oxytocin Administration (Intravenous, then Intranasal)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Volunteer Study Patient Testimony for trial: Trial Name: NCT05672667 — Phase 1