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Hormone Therapy

Oxytocin for Pain Relief

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 114 minutes after baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial is to study the effects of oxytocin on pain relief.

Who is the study for?
This trial is for men and women aged 18-75 with a BMI under 40. Women of childbearing age must use effective birth control. Participants should be in good health or, if they have knee arthritis, have controlled blood pressure. People can't join if they're pregnant, nursing, recently pregnant, have certain chronic conditions like neuropathy or diabetes, take daily pain medications, or are allergic to Pitocin ingredients.
What is being tested?
The study tests how oxytocin given by IV affects pain relief at the site of injection in healthy volunteers and those with severe knee arthritis. The drug's effects on skin perception will be measured using a heated probe while participants rate their pain on a scale from 0 to 10.
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects may include reactions at the infusion site such as redness or swelling; changes in heart rate; nausea; headache; emotional changes due to oxytocin's known effects on mood and social bonding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~114 minutes after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 114 minutes after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Verbal pain after heating the skin to 45 degrees Celsius

Side effects data

From 2023 Phase 4 trial • 108 Patients • NCT04028765
6%
Blood transfusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Misoprostol-Mothers
Oxytocin-Mothers
Oral Misoprostol-Fetus/Neonate
Oxytocin-Fetus/Neonate

Awards & 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: OxytocinExperimental Treatment1 Intervention
Oxytocin will be administered at increasing and decreasing rates
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
2016
Completed Phase 4
~2340

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,395 Previous Clinical Trials
2,460,129 Total Patients Enrolled
10 Trials studying Osteoarthritis
924 Patients Enrolled for Osteoarthritis
James C Eisenach, MDPrincipal InvestigatorWake Forest University Health Sciences
17 Previous Clinical Trials
780 Total Patients Enrolled
1 Trials studying Osteoarthritis
80 Patients Enrolled for Osteoarthritis

Media Library

Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04435704 — Phase 2
Osteoarthritis Research Study Groups: Oxytocin
Osteoarthritis Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT04435704 — Phase 2
Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04435704 — Phase 2
~7 spots leftby Dec 2025
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