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Hormone Therapy

Oxytocin for Knee Osteoarthritis

Phase 2
Recruiting
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 65 minutes after the beginning of the oxytocin infusion
Awards & highlights

Study Summary

This trial is studying oxytocin to see if it can reduce pain in people with severe knee arthritis.

Who is the study for?
This trial is for adults aged 18-75 with a BMI under 40, either healthy or suffering from severe knee arthritis. Healthy participants must have normal blood pressure and heart rate without medication; those with arthritis can be on blood pressure meds. Women of childbearing age should use effective birth control.Check my eligibility
What is being tested?
The study tests the pain-reducing effects of oxytocin, given through an IV, in response to sustained heat applied to the skin. Participants will rate their pain during this process to help develop a model for peripheral analgesia using oxytocin.See study design
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information but may include reactions at the infusion site, changes in blood pressure or heart rate due to oxytocin's known effects on smooth muscle tissue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~65 minutes after the beginning of the oxytocin infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 65 minutes after the beginning of the oxytocin 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
Oxytocin

Trial Design

1Treatment groups
Experimental Treatment
Group I: OxytocinExperimental Treatment1 Intervention
Oxytocin administered by IV infusion
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
1,243 Previous Clinical Trials
1,004,688 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
797 Total Patients Enrolled
1 Trials studying Osteoarthritis
80 Patients Enrolled for Osteoarthritis

Media Library

Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04431206 — Phase 2
Osteoarthritis Research Study Groups: Oxytocin
Osteoarthritis Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT04431206 — Phase 2
Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04431206 — Phase 2

Frequently Asked Questions

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

Does this experiment accept participants who are over sixty years old?

"This clinical trial is seeking participants aged between 18 and 75. However, there are 36 trials that include minors and 459 studies exclusively open to those over 65 years of age."

Answered by AI

To what extent is this clinical trial being utilized by participants?

"Affirmative. This medical trial, which was initially published on November 4th 2020, is actively looking for participants to join its ranks as per information stored by clinicaltrials.gov. 38 individuals are sought from a single site at this time."

Answered by AI

Is enrollment still open for this clinical trial?

"Affirmative. Clinicaltrials.gov displays that this trial, which was initially submitted on November 4th 2020, is in the process of recruiting patients. 38 test subjects need to be recruited from 1 site specifically."

Answered by AI

For what medical conditions is Oxytocin prescribed?

"Oxytocin is a commonly prescribed medication for dealing with haemorrhage, as well as aiding labour and uterine contraction. It also serves to augment the process of birth."

Answered by AI

What evidence exists to support the safety of Oxytocin ingestion?

"Oxytocin scored a safety rating of 2, as the clinical data indicates that there is some backing for its use but no efficacy studies have been conducted yet."

Answered by AI

Who meets the eligibility criteria for this clinical experiment?

"This clinical trial seeks to enrol 38 members of the public aged between 18 and 75 who are suffering from osteoarthritis in the knee. Notably, female participants must demonstrate that they are using highly effective forms of birth control such as hormonal methods (e.g., combined oral contraceptives), double barrier methods (e.g., condoms plus spermicidal jellies or cream) or have been abstinent for a full cycle before trial administration, while all applicants must possess a BMI below 40."

Answered by AI
~7 spots leftby Feb 2025