Hypermobile Ehlers-Danlos SyndromePhase 1/2EDS-OXYNCT05405257
Oxytocin for Hypermobile Ehlers-Danlos Syndrome
A Phase 1/2 study testing Oxytocin in people with Hypermobile Ehlers-Danlos Syndrome and Pain Assessment, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate effect of IV oxytocin on chronic pain in patients with Hypermobile Ehlers Danlos syndrome. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Hypermobile Ehlers-Danlos Syndrome, Pain Assessment
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2022to 11 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oxytocin Treatment for Chronic Pain in Hypermobile Ehlers-Danlos Syndrome
The purpose of this pilot study is to evaluate effect of IV oxytocin on chronic pain in patients with Hypermobile Ehlers Danlos syndrome.
Read the 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 multiple factors including the menstrual period. In order to have minimum variation between tested individuals we conduct this study in females at the same stage of their menstrual cycles. Hypermobile EDS is more prevalent in females and the symptoms are usually more severe in females and more females come to medical attention. We are not aware of any difference in the risk from using oxytocin in females vs males.
All participating individuals are affected with hypermobile-EDS (hEDS) with chronic moderate to severe pain. Study will include two periods of treatment - one with placebo and one with oxytocin and a one month period will be held in between the two treatments. Participants will be blinded to the order of treatment. Each period of treatment will start 7-10 days after the beginning of the menstrual cycle and will include 6 days of daily subjective pain evaluation using pain-evaluation questionnaire ('preinfusion evaluation') followed by three consecutive daily infusions (placebo or oxytocin). Response to treatment will be evaluated by questionnaire during 6 days after each three infusion days (placebo or oxytocin) . Additional questionnaires for evaluation of anxiety and depression will be used as well. Patients will be asked to wear ACTIHEART device (measures heart rate, heart rate variation, and activity levels) 3 days prior to infusion, during the 3 days of infusion, and in the 3 days after the last infusion day. For each infusion period, participants will arrive to the study site for three daily consecutive visits, each will last for 3-4 hours. Response variables will be collected prior, during and after each infusion. Patients will fill out pain evaluation questionnaires pre and post infusion and some questionnaires during the days of infusion. Blood pressure and heart rate measurements will be taken prior, during and after the infusion. Blood samples for measurements of oxytocin levels and blood samples for future analysis will be collected in some of the infusion days (before and after the infusion).
- Being tested
- Oxytocin, Placebo
- Keywords
- EDS, Oxytocin, Pain, Hypermobile Ehlers-Danlos Syndrome
- Medical subject headings
- Ehlers-Danlos syndrome type 3, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
IV 1IU Oxytocin in 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day).
PlaceboOther
IV, 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day).
| Study group | Role | What they receive |
|---|---|---|
| Placebo-Oxytocin sequence | Experimental | In this single blind fixed sequence study participants were treated with Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes once a day for three consecutive days (one per day) and a after a washout of at least a month 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) Receives: Drug: Oxytocin; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Participant's Subjective Reported Chronic Pain
Study evaluated maximum pain level by using the Brief Pain Inventory (BPI). Scale range from minimum value of 1 to maximum value of 10. Higher score indicated more pain (worse outcome).
Measured: Pain was self reported and documented on days 1, 3, and 5 of the 6 days period prior or after the treatment with oxytocin or with placebo. An average of the three data points pre or post treatment were calculated.
Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire.
Change in the individual's subjective reported pain following treatment with placebo compared to the change in reported pain following treatment with oxytocin as assessed by McGill Pain Questionnaire.
The McGill questionnaire is a self-report measure that explores both the quality and intensity of pain. Minimum score: is 0 (no pain) and maximum score is 78 (severe pain). Higher score indicates higher level of pain (worse outcome)
Measured: Once prior to treatment with placebo OR oxytocin (day 1 of pre-infusion period / 6 days prior to the infusion) and once after treatment with placebo OR oxytocin (day 1 of post-infusion period / 1 day after the infusion)
Change in Participant's Subjective Reported Pain
Study evaluated maximum pain level by using the Numerical pain rating scale. Scale range from minimum value of 1 to maximum value of 10. Higher score indicated more pain (worse outcome).
Measured: Pain was self reported and documented on days 1, 3, and 5 of the 6 days period prior or after the treatment with oxytocin or with placebo. An average of the three data points pre or post treatment were calculated.
Secondary outcomes (3)
Change Between Pre and Post Treatment Anxiety Scores Using the Hospital Anxiety and Depression Scale Questionnaire.
Change in the individual's anxiety following treatment with placebo compared to the change in reported anxiety following treatment with oxytocin as assessed by Hospital anxiety and depression scale The Hospital anxiety and depression scale is a self-report measure to evaluate anxiety and depression. Minimum score is 0 and maximum score is 21. Higher score indicates higher level of anxiety (worse outcome) 0-7: Normal or no anxiety/depression. 8-10: Mild anxiety/depression. 11-14: Moderate anxiety/depression. 15-21: Severe anxiety/depression.
Measured: Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion)
Change Between Pre and Post Treatment Depression Scores Using the Hospital Anxiety and Depression Scale Questionnaire.
Change in the individual's depression following treatment with placebo compared to the change in reported depression following treatment with oxytocin as assessed by Hospital anxiety and depression scale The Hospital anxiety and depression scale is a self-report measure to evaluate anxiety and depression. Minimum score is 0, maximum score is 21. Higher score indicates higher level of depression (worse outcome) 0-7: Normal or no anxiety/depression. 8-10: Mild anxiety/depression. 11-14: Moderate anxiety/depression. 15-21: Severe anxiety/depression.
Measured: Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion)
Change Between Pre and Post Treatment Anxiety Scores Using the "State" Part of the State-Trait Anxiety Inventory (STAI) Questionnaire.
Change in the individual's anxiety following treatment with placebo compared to the change in reported anxiety following treatment with oxytocin as assessed by the "state" part of the State-Trait Anxiety Inventory (STAI) questionnaire. The State-Trait Anxiety Inventory (STAI) is a measure of trait and state anxiety. Minimum score is 20 to maximum score is 80. Higher score indicates higher level of anxiety (worse outcome)
Measured: Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start13 May 2022
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
Why it stopped: Study team has decided to close the trial (NCT05405257) due problems with patient recruitment and enrollment efforts. To date, only one patient completed both arms.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypermobile Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a single-blind study. This study will include two treatment periods in a fixed order. One for placebo and one for oxytocin. The participants was blinded to the sequence of treatment assignment which is fixed.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brendan Lee, Baylor College of Medicine
- Investigators
- Brendan Lee, MD, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405257
- Sponsor's protocol ID
- H-45648
- Acronym
- EDS-OXY
- Status last verified
- Aug 2025
- First submitted
- 2 Jun 2022
- Last updated
- 28 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Treatment for Chronic Pain in Hypermobile Ehlers-Danlos Syndrome
- ClinicalTrials.gov ID
- NCT05405257
- Acronym / sponsor ID
- EDS-OXY / H-45648
- Keywords
- EDS, Oxytocin, Pain, Hypermobile Ehlers-Danlos Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study team has decided to close the trial (NCT05405257) due problems with patient recruitment and enrollment efforts. To date, only one patient completed both arms.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Posted 28 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 multiple factors including the menstrual period. In order to have minimum variation between tested individuals we conduct this study in females at the same stage of their menstrual cycles. Hypermobile EDS is more prevalent in females and the symptoms are usually more severe in females and more females come to medical attention. We are not aware of any difference in the risk from using oxytocin in females vs males.
All participating individuals are affected with hypermobile-EDS (hEDS) with chronic moderate to severe pain. Study will include two periods of treatment - one with placebo and one with oxytocin and a one month period will be held in between the two treatments. Participants will be blinded to the order of treatment. Each period of treatment will start 7-10 days after the beginning of the menstrual cycle and will include 6 days of daily subjective pain evaluation using pain-evaluation questionnaire ('preinfusion evaluation') followed by three consecutive daily infusions (placebo or oxytocin). Response to treatment will be evaluated by questionnaire during 6 days after each three infusion days (placebo or oxytocin) . Additional questionnaires for evaluation of anxiety and depression will be used as well. Patients will be asked to wear ACTIHEART device (measures heart rate, heart rate variation, and activity levels) 3 days prior to infusion, during the 3 days of infusion, and in the 3 days after the last infusion day. For each infusion period, participants will arrive to the study site for three daily consecutive visits, each will last for 3-4 hours. Response variables will be collected prior, during and after each infusion. Patients will fill out pain evaluation questionnaires pre and post infusion and some questionnaires during the days of infusion. Blood pressure and heart rate measurements will be taken prior, during and after the infusion. Blood samples for measurements of oxytocin levels and blood samples for future analysis will be collected in some of the infusion days (before and after the infusion).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a single-blind study. This study will include two treatment periods in a fixed order. One for placebo and one for oxytocin. The participants was blinded to the sequence of treatment assignment which is fixed.
| Arm | Type | Receives |
|---|---|---|
| Placebo-Oxytocin sequence | Experimental | Drug: Oxytocin, Other: PlaceboIn this single blind fixed sequence study participants were treated with Placebo infusion: IV 0.9% NaCl, rate is 200ml over 40 minutes once a day for three consecutive days (one per day) and a after a washout of at least a month 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) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinIV 1IU Oxytocin in 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day). | Drug | Placebo-Oxytocin sequence |
| PlaceboIV, 200 ml 0.9%NaCl over 40 minutes. Total of three infusions in three consecutive days (one per day). | Other | Placebo-Oxytocin sequence |
Primary outcome
Change in Participant's Subjective Reported Chronic Pain
Time frame: Pain was self reported and documented on days 1, 3, and 5 of the 6 days period prior or after the treatment with oxytocin or with placebo. An average of the three data points pre or post treatment were calculated.
Study evaluated maximum pain level by using the Brief Pain Inventory (BPI). Scale range from minimum value of 1 to maximum value of 10. Higher score indicated more pain (worse outcome).
Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire.
Time frame: Once prior to treatment with placebo OR oxytocin (day 1 of pre-infusion period / 6 days prior to the infusion) and once after treatment with placebo OR oxytocin (day 1 of post-infusion period / 1 day after the infusion)
Change in the individual's subjective reported pain following treatment with placebo compared to the change in reported pain following treatment with oxytocin as assessed by McGill Pain Questionnaire. The McGill questionnaire is a self-report measure that explores both the quality and intensity of pain. Minimum score: is 0 (no pain) and maximum score is 78 (severe pain). Higher score indicates higher level of pain (worse outcome)
Change in Participant's Subjective Reported Pain
Time frame: Pain was self reported and documented on days 1, 3, and 5 of the 6 days period prior or after the treatment with oxytocin or with placebo. An average of the three data points pre or post treatment were calculated.
Study evaluated maximum pain level by using the Numerical pain rating scale. Scale range from minimum value of 1 to maximum value of 10. Higher score indicated more pain (worse outcome).
3 secondary outcomes
Change Between Pre and Post Treatment Anxiety Scores Using the Hospital Anxiety and Depression Scale Questionnaire.
Time frame: Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion)
Change Between Pre and Post Treatment Depression Scores Using the Hospital Anxiety and Depression Scale Questionnaire.
Time frame: Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion)
Change Between Pre and Post Treatment Anxiety Scores Using the "State" Part of the State-Trait Anxiety Inventory (STAI) Questionnaire.
Time frame: Once prior to treatment with placebo OR oxytocin (day 6 of pre-infusion period / 1 day prior to the infusion) and once after treatment with placebo OR oxytocin (day 6 of post-infusion period / 6 days after the infusion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan Lee, MD, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oxytocin in people with Hypermobile Ehlers-Danlos Syndrome and Pain Assessment, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Participant's Subjective Reported Chronic Pain (time frame: Pain was self reported and documented on days 1, 3, and 5 of the 6 days period prior or after the treatment with oxytocin or with placebo. An average of the three data points pre or post treatment were calculated.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.