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Hormone Therapy

First infusion day high dose oxytocin, Second infusion day low dose oxytocin for Healthy Volunteer Study

Phase 2
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 45 min after the end of each study drug infusion
Awards & highlights

Study Summary

This trial is testing oxytocin as a possible pain reliever. The study will give people oxytocin or a placebo through an IV, then test how well the person tolerates heat pain. The goal is to see if oxytocin can help relieve pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 min after the end of each study drug infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 min after the end of each study drug infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Response of Intravenous Oxytocin on Sustained Heat Pain

Trial Design

2Treatment groups
Experimental Treatment
Group I: First infusion day low dose oxytocin, Second infusion day high dose oxytocinExperimental Treatment2 Interventions
On the first oxytocin study day, participants will receive a 10 minute IV infusion of saline then one hour later will receive a 10 minute infusion of oxytocin 1.3 micrograms. On the second study day they will receive a 10 minute IV infusion of oxytocin 0.3 micrograms then one hour later will receive a 10 minute infusion of oxytocin 7 micrograms.
Group II: First infusion day high dose oxytocin, Second infusion day low dose oxytocinExperimental Treatment2 Interventions
On the first oxytocin study day, participants will receive a 10 minute IV infusion of oxytocin 0.3 micrograms then one hour later will receive a 10 minute infusion of oxytocin 7 micrograms. On the second study day they will receive a 10 minute IV infusion of saline then one hour later will receive a 10 minute infusion of oxytocin 1.3 micrograms.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low dose oxytocin
2022
Completed Phase 2
~30
High dose oxytocin
2022
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,158 Total Patients Enrolled
2 Trials studying Healthy Volunteer Study
44 Patients Enrolled for Healthy Volunteer Study
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

Frequently Asked Questions

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

How many participants have signed up so far to participate in this trial?

"Affirmative. Clinicaltrials.gov data depicts that the recruitment for this medical study is ongoing, beginning on 9th May 2022 and last edited 11th November 2022. The research requires 24 participants from a single site."

Answered by AI

Is it possible to join this investigation at the moment?

"Affirmative. Clinicaltrials.gov displays that this medical experiment was initially posted on May 9th 2022 and recently modified on November 11th 2022 is actively recruiting individuals for participation. 24 test subjects are needed at a single location."

Answered by AI

What therapeutic purpose does the administration of oxytocin 0.3 micrograms followed by 7 micrograms typically serve?

"For the most part, oxytocin 0.3 micrograms followed by 7 micrograms is employed to address hemorrhage. However, it may also be prescribed for labour reinforcement or uterine contraction management in certain cases."

Answered by AI

Are there any requirements that would preclude me from participating in this experiment?

"This study is looking to enroll 24 participants between the age of 18 and 75. To be eligible, individuals must demonstrate a history of healthy behaviour as well as meet certain criteria; females of child-bearing potential or less than one year post-menopausal are expected to use an effective form of birth control while male and female applicants should both have a BMI below 40."

Answered by AI

Is the age criteria for admission to this trial restricted beyond thirty years old?

"This clinical trial is only open to participants aged 18-75. For those below the age of consent, there are 9 studies available, and 32 trials for patients above 65 years old."

Answered by AI

Is there any danger posed to individuals when utilizing Experimental: oxytocin 0.3 micrograms followed by oxytocin 7 micrograms?

"Our team has assigned Experimental: oxytocin 0.3 micrograms then oxytocin 7 micrograms a rating of 2 based on the Phase 2 trial data that suggests its safety; however, there is currently no evidence for efficacy."

Answered by AI

Who else is applying?

What state do they live in?
California
Georgia
Other
North Carolina
How old are they?
18 - 65
What site did they apply to?
Wake Forest Baptist Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Dose Ranging Study of Intravenous Oxytocin for Analgesia to Heat Pain
2022. "Dose Ranging Study of Intravenous Oxytocin for Analgesia to Heat Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05179421.
~9 spots leftby Apr 2025
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