Status:
TERMINATED
Oxytocin for Hypermobile Ehlers-Danlos Syndrome
Lead Sponsor:
Baylor College of Medicine
Conditions:
Hypermobile Ehlers-Danlos Syndrome
Pain Assessment
Eligibility:
FEMALE
18-64 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this pilot study is to evaluate effect of IV oxytocin on chronic pain in patients with Hypermobile Ehlers Danlos syndrome.
Detailed Description
This will be a single-site study to evaluate the effect of IV oxytocin on chronic pain in female adult patients with hypermobile EDS. Oxytocin secretion in the body is dynamic and can be affected by ...
Eligibility Criteria
Inclusion
- 1\) Premenopausal Females, Age \>18 years 2) Clinical diagnosis of hypermobile EDS according to the 2017 criteria for hEDS 3) Menstrual periods (range from 8 to 42 days) 4) Pain level greater that pain score of 4 out of 10 on a Numeric Rating Scale in at least two of the following locations: back, neck, shoulders, elbows, wrist, hand joints, hips, knees, ankles, on most days over the 3 months preceding enrollment. 5) On a stable regimen for pain control without any expected increase in dose of pain medications during the study period. 6) All participants should have a negative urine pregnancy test and agree to use an acceptable method of contraception (abstinence or barrier methods).
Exclusion
- 1\) Known allergy to OXT or preservatives in the medication 2) Pregnancy 3) Lactation 4) A confirmed clinical diagnosis of autoimmune disorders that lead to joint inflammation and joint pain such as SLE, RA, psoriatic arthritis, ankylosing spondylitis, scleroderma, and enteropathic arthritis 5) History of known cardiac arrhythmias (except for asymptomatic sinus tachycardia and sinus bradycardia) 6) Heart rate persistently greater than 110/min or less than 50 per minute 7) QTC of \> 450 ms from EKG (electrocardiogram) test 8) Taking oral or other hormonal contraceptives 9) Individuals with a clinical condition which, in the view of the investigator compromises safety 10) Participating in another interventional study.
Key Trial Info
Start Date :
May 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2025
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05405257
Start Date
May 13 2022
End Date
March 11 2025
Last Update
August 28 2025
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030