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Hormone Therapy

Oxytocin for Osteoarthritis

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 after oxytocin infusion 14 minutes after baseline
Awards & highlights

Study Summary

This trial will help to estimate the maximum effect oxytocin has on pain and to get an estimate for the relationship between the amount of pain relief and different concentrations of oxytocin in the blood.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after oxytocin infusion 14 minutes after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and after oxytocin infusion 14 minutes after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacodynamics of heat pain after oxytocin
Pharmacodynamics of heat pain oxytocin 16 pg/ml
Pharmacodynamics of heat pain oxytocin 256 pg/ml
+3 more
Secondary outcome measures
Pharmacokinetics of oxytocin in serum 16 pg/ml
Pharmacokinetics of oxytocin in serum 256pg/ml
Pharmacokinetics of oxytocin in serum 4pg/ml
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Oxytocin 64 picogram/millilitreExperimental Treatment1 Intervention
Oxytocin infused to maintain serum concentration of 64 picogram/millilitre
Group II: Oxytocin 4 picogram/millilitreExperimental Treatment1 Intervention
Oxytocin infused to maintain serum concentration of 4 picogram/millilitre
Group III: Oxytocin 256 picogram/millilitreExperimental Treatment1 Intervention
Oxytocin infused to maintain serum concentration of 256 picogram/millilitre
Group IV: Oxytocin 16 picogram/millilitreExperimental Treatment1 Intervention
Oxytocin infused to maintain serum concentration of 16 picogram/millilitre
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
1,239 Previous Clinical Trials
1,004,183 Total Patients Enrolled
8 Trials studying Osteoarthritis
684 Patients Enrolled for Osteoarthritis
James C Eisenach, MDPrincipal InvestigatorWake Forest University Health Sciences
17 Previous Clinical Trials
835 Total Patients Enrolled
1 Trials studying Osteoarthritis
80 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

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

What therapeutic applications does Oxytocin have?

"Oxytocin can be prescribed for cases of hemorrhage and used to support labour progress, induce uterine contraction, and strengthen childbirth."

Answered by AI

Has Oxytocin been officially sanctioned by the FDA?

"The safety of Oxytocin has been partially validated in Phase 2 clinical trials, therefore our team at Power assigned a rating of 2. There is some data supporting the drug's security profile but no proof that it works therapeutically."

Answered by AI

What are the primary goals being sought through this medical research?

"The primary purpose of the trial, which will run for a 29-minute period after baseline time, is to assess the pharmacodynamics of oxytocin at 256 pg/ml. The secondary outcomes involve measuring oxytocin concentrations in serum samples collected at 64pg/ml and 16 pg/ml respectively; accuracy will be assessed by comparing targeted versus observed values."

Answered by AI

To what extent is this research endeavor being conducted with human volunteers?

"Unfortunately, this clinical trial has closed its recruitment period. Initially posted on December 1st 2022 and amended lastly on May 6th of the same year, it is no longer taking patients for participation. However, if you are seeking another study to join, 456 studies focused on osteoarthritis in knees are currently recruiting as well 53 research projects centered around Oxytocin."

Answered by AI

Who qualifies to participate in this research?

"This scientific investigation requires the participation of 20 people that have been diagnosed with osteoarthritis in their knee and are between 18-75 years old. Additionally, all female subjects must be practicing highly effective birth control techniques such as hormonal methods or double barrier methods for at least a month before receiving any study drugs. Male and female participants should also possess a BMI lower than forty to qualify."

Answered by AI

Is this research endeavor actively inviting individuals above the age of 55 to join?

"This trial is seeking volunteers of legal age (18+) and who have not yet reached the age of 75."

Answered by AI

Is it currently feasible to join this clinical experiment?

"Currently, this medical trial is not actively enrolling patients. Initially posted on December 1st 2022, the trial's last update was made on May 6th 2022. For those searching for other clinical trials related to osteoarthritis or Oxytocin, there are 456 and 53 studies respectively that are currently recruiting participants."

Answered by AI
~0 spots leftby Jan 2025