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Hormone Therapy

Oxytocin for Ehlers-Danlos Syndrome (EDS-OXY Trial)

Phase 1 & 2
Recruiting
Led By Brendan Lee, MD, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Premenopausal Females, Age >18 years
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for each arm we will compare pain levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. this difference will be compared between the two treatment arms.
Awards & highlights

EDS-OXY Trial Summary

This trial is testing whether oxytocin can help reduce pain in people with a connective tissue disorder.

Who is the study for?
This trial is for premenopausal females over 18 with hypermobile Ehlers-Danlos syndrome who experience chronic pain in multiple joints. Participants must have a stable pain management regimen and agree to use non-hormonal contraception. Excluded are those with certain heart conditions, autoimmune disorders causing joint inflammation, pregnancy, lactation, or allergies to oxytocin.Check my eligibility
What is being tested?
The study tests the effect of intravenous oxytocin on chronic pain against a placebo in patients with Hypermobile Ehlers-Danlos Syndrome (hEDS). It's designed to see if oxytocin can reduce their pain levels more effectively than a placebo.See study design
What are the potential side effects?
Possible side effects of IV oxytocin may include allergic reactions, changes in heart rate or rhythm, and local reactions at the infusion site. Since it's being compared to a placebo, some participants might not experience any active drug-related side effects.

EDS-OXY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman over 18 and have not gone through menopause.
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I have had pain greater than 4/10 in my back, neck, or joints most days in the last 3 months.
Select...
I have had pain greater than 4/10 in my back, neck, or joints most days in the last 3 months.
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My pain medication dose is stable and won't increase during the study.
Select...
I have been diagnosed with hypermobile EDS based on the 2017 criteria.

EDS-OXY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for each arm we will compare anxiety levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. this difference will be compared between the two treatment arms.
This trial's timeline: 3 weeks for screening, Varies for treatment, and for each arm we will compare anxiety levels reported 6 days before infusion, 3 days of infusion, and 6 days post-infusion. this difference will be compared between the two treatment arms. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in participant's subjective reported chronic pain
Secondary outcome measures
Change in activity level
Heart rate
Anxiety
+1 more
Other outcome measures
Change in participant's pain levels assessed by numerical rating
Change in participant's pain levels by evaluating pain experience

EDS-OXY Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: OxytocinActive Control1 Intervention
Treatment infusion: IV 1IU Oxytocin in 200ml of 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)
Group II: PlaceboPlacebo Group1 Intervention
Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes. Total of three infusions in three consecutive days (one per day)

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,192 Total Patients Enrolled
1 Trials studying Ehlers-Danlos Syndrome
40 Patients Enrolled for Ehlers-Danlos Syndrome
Brendan Lee, MD, PhDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05405257 — Phase 1 & 2
Ehlers-Danlos Syndrome Research Study Groups: Placebo, Oxytocin
Ehlers-Danlos Syndrome Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT05405257 — Phase 1 & 2
Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05405257 — Phase 1 & 2

Frequently Asked Questions

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

Is there an opportunity to join this investigation?

"This clinical trial is accepting a cohort of 20 premenopausal females aged 18-64 with hypermobile Ehlers-Danlos Syndrome who have experienced chronic pain (rated 4/10 or higher on the Numeric Rating Scale) in at least two locations - neck, shoulders, elbows, wrists and hand joints; hips, knees and ankles - over the past three months. Furthermore, applicants must not be planning to increase their dose of pain medication during this study period and will need to provide proof that they are using an adequate form of contraception such as abstinence or barrier methods."

Answered by AI

Are there any openings for enrolment in this trial?

"According to the clinicaltrials.gov record, this particular trial is no longer recruiting participants; it was last updated on June 3rd of 2022 and first posted on May 13th. However, there are a myriad of other medical studies that are accepting patients at present - 1,385 in total."

Answered by AI

Is the age requirement for this trial above or below 50 years old?

"According to the guidelines for enrollment, potential participants in this trial must be between 18 and 64 years of age. There are 375 studies dedicated to individuals under 18 and 984 clinical trials focusing on elderly patients above 65."

Answered by AI

Who else is applying?

What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

pain flares come up frequently for me anytime diet or illness arises only pain management used now is heat, lidocaine patches, warm baths and doesn't work also use compression clothing when in a flare but wake at night in pain and discomfort - can't sleep through night when in a flare.
PatientReceived 2+ prior treatments
I have hit a point where nothing really helps my pain. I truly can't remember the last time I was pain free and it'd be really nice to have some relief even if its short term. Outside of that, I see the lack of knowledge around Ehlers-Danlos Syndrome and if I can do anything to help others also dealing with it then I can find happiness in that.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Are there any markers that disqualify for this trial?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Oxytocin for Hypermobile Ehlers-Danlos Syndrome
Brendan Lee 2022. "Oxytocin for Hypermobile Ehlers-Danlos Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05405257.
All > Oxytocin
~0 spots leftby May 2024
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