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Oxytocin Administration in Healthy Volunteers
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 belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- 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.
- Group 1: Oxytocin Intravenous
- Group 2: Oxytocin intranasal
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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