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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
Body Mass Index (BMI) <40
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes after intranasal oxytocin administration
Awards & highlights

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your body mass index (BMI) should be less than 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes after intranasal oxytocin administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes after intranasal oxytocin administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics of oxytocin in plasma

Trial Design

2Treatment groups
Experimental Treatment
Group I: Oxytocin intranasalExperimental Treatment1 Intervention
Oxytocin 102 micrograms self administered into nasal passages
Group II: Oxytocin IntravenousExperimental Treatment1 Intervention
Oxytocin 14 micrograms infusion over 30 minutes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
intravenous oxytocin
2023
Completed Phase 1
~190
intranasal oxytocin
2017
Completed Phase 1
~380

Find a Location

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
1,231 Previous Clinical Trials
1,001,789 Total Patients Enrolled
2 Trials studying Healthy Volunteer Study
44 Patients Enrolled for Healthy Volunteer Study
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,335 Previous Clinical Trials
648,507 Total Patients Enrolled
James C Eisenach, MDPrincipal InvestigatorWake Forest University Health Sciences
17 Previous Clinical Trials
810 Total Patients Enrolled
2 Trials studying Healthy Volunteer Study
44 Patients Enrolled for Healthy Volunteer Study

Media Library

Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05672667 — Phase 1
Healthy Volunteer Study Research Study Groups: Oxytocin Intravenous, Oxytocin intranasal
Healthy Volunteer Study Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT05672667 — Phase 1
Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05672667 — Phase 1
Healthy Volunteer Study Patient Testimony for trial: Trial Name: NCT05672667 — Phase 1

Frequently Asked Questions

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

Are individuals aged 25 or over eligible to participate in this trial?

"This research is open to participants who have surpassed the age of consent and are younger than 75 years old."

Answered by AI

Have the FDA accepted Oxytocin Intravenous and Oxytocin intranasal for therapeutic use?

"The safety rating of Oxytocin Intravenous and Oxytocin intranasal was assessed as a 1, considering this is an early Phase 1 trial with limited supporting evidence for safety and efficacy."

Answered by AI

Are there any vacancies in this clinical experiment for participants?

"This trial, which was initially posted on February 1st 2023 and last updated December 20th 2022, is no longer enrolling patients. However, 4 other studies are actively recruiting participants at this time as per clinicaltrials.gov records."

Answered by AI

For whom is this medical study an appropriate opportunity?

"This trial is recruiting 24 participants who meet the following requirements: aged 18-75, Body Mass Index (BMI) <40., Generally in good health as determined by Principal Investigator's medical history assessment, American Society of Anesthesiologists physical status 1 or 2., Unmedicated normal blood pressure and resting heart rate for healthy volunteers; hypertension patients must be on anti-hypertensive medication with a resting heart rate between 45-100 beats per minute. Females of childbearing potential and those less than one year postmenopausal must demonstrate proper contraception usage such as hormonal methods combined with double barrier contraceptives like condoms."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
What site did they apply to?
Wake Forest Baptist Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am an adult Autistic person who is otherwise in good physical health. I am 34 years old. I suffered from negative effects of Autism since about 11 years of age. I have been committed to a psychiatric behavioral hospital , three times in the last 2 years. I have been prescribed many different types of medication over the years none have helped more the a few weeks. I experience Depression, Suicidal ideation, severe anxiety and have had panic attacks. On some occasions, when I get upset, I'll continue to a Meltdown point where Either I've done something to send me to the hospital or I'm able to take a prescribed Rx Clonazepam. This can calm me down, If I take it in time. My father and I believe, because of my symptoms, that a drug that targets the Amygdala might reduce my emotional outbursts and negative off the scale reactions to normal everyday stresses. My therapists cannot perscribe Oxytocin because it is in Trials right now.
PatientReceived 1 prior treatment
~12 spots leftby Mar 2025