Trial Summary
What is the purpose of this trial?This trial is testing if a treatment can help reduce long-term pain in women with a specific condition. The treatment might work by influencing how the body processes pain and emotions. It has been increasingly investigated for its potential in pain relief, with initial studies focusing on its effects during labor and breastfeeding.
Is the drug Oxytocin a promising treatment for Ehlers-Danlos Syndrome?Oxytocin is a naturally occurring hormone that has shown potential in managing pain, which could be beneficial for people with Ehlers-Danlos Syndrome who often experience chronic pain. It is also well-tolerated with few side effects, making it a promising option to explore further.123413
What safety data exists for oxytocin treatment in Ehlers-Danlos Syndrome?The provided research does not contain specific safety data for oxytocin or its other names (Pitocin, Syntocinon, Viatocinon) in the treatment of Ehlers-Danlos Syndrome. The articles focus on endocrine-disrupting chemicals and their regulation, but do not address oxytocin or its safety profile.5681011
What data supports the idea that Oxytocin for Ehlers-Danlos Syndrome is an effective treatment?The available research shows that oxytocin has been studied for its effects on pain perception and chronic pain conditions. However, the studies do not provide strong evidence that oxytocin is effective for Ehlers-Danlos Syndrome specifically. In a study on fibromyalgia, oxytocin did not show positive therapeutic effects, although it was safe to use. Another study found that oxytocin increased pain perception in women with chronic neck and shoulder pain, suggesting it might not be effective for pain relief in all cases. Overall, the data does not strongly support oxytocin as an effective treatment for Ehlers-Danlos Syndrome.79121314
Do I have to stop taking my current medications?The trial requires that you stay on a stable regimen for pain control without increasing the dose during the study. It does not specify stopping other medications.
Eligibility Criteria
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.Inclusion Criteria
I am a woman over 18 and have not gone through menopause.
I have had pain greater than 4/10 in my back, neck, or joints most days in the last 3 months.
I have had pain greater than 4/10 in my back, neck, or joints most days in the last 3 months.
My pain medication dose is stable and won't increase during the study.
I have been diagnosed with hypermobile EDS based on the 2017 criteria.
Exclusion Criteria
I have a history of heart rhythm problems, except for harmless fast or slow beats.
I have been diagnosed with an autoimmune disorder that causes joint pain.
I am currently using hormonal birth control.
Treatment Details
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.
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)
Oxytocin is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Pitocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇪🇺 Approved in European Union as Syntocinon for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇨🇦 Approved in Canada as Oxytocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
🇦🇺 Approved in Australia as Oxytocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
Find a clinic near you
Research locations nearbySelect from list below to view details:
Baylor College of MedicineHouston, TX
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
References
A new approach to the hormonal treatment of impotentia erectionis. [2009]The influence of oraly administered synthetic oxytocin (Syntocinon, Sandoz) on the impotentia erectionis has been studied in a double-blind trial in comparison to placebo. Twenty-nine out-patients divided into 3 groups were treated for a minimum of 7 weeks. Nine patients were given 300 IU daily, ten patients 600 IU daily and further 10 patients placebo. The treatment with 300 IU of oxytocin daily has shown the best therapeutic results. The difference between this group and the placebo group was statistically significant regarding the overall parameters sexual interest and sexual capability (P less than 0.05) and P less than 0.10 respectively). The daily oral dose of 600 IU produced no significant therapeutic effect. Oxytocin in both dosage schedules was well tolerated and no untoward side effects were observed.
Anaphylactoid reaction to oxytocin in pregnancy. [2019]A case of an allergic reaction to Syntocinon (synthetic oxytocin) administered during Caesarean section is reported.
Synthetic oxytocin. [2018]A synthetic oxytocin, Syntocinon(R), was used in 3,342 obstetrical patients for a wide variety of indications. It was concluded that the preparation is as effective as natural oxytocin.(1) There were no side effects observed, particularly vasospasm or anaphylactic reaction. Its use in clinical obstetrics can be recommended provided there is a proper indication for its use and the need for close supervision and individual adjustment of dosage is recognized.
Variations in oxytocin regimes in Scottish labour wards in 1998. [2004]Oxytocin (Syntocinon, Sandoz Pharmaceuticals) is a commonly used drug in the modern management of labour. A recently published British survey found that 38% of low risk primigravid labours were augmented, most commonly by intravenous syntocinon. Unfortunately the misuse of syntocinon can lead to potentially serious problems for the fetus and mother. Despite the frequency of usage there appears to be no consensus as to the optimal dose and mode of administration. This paper explores the extent of this variation among Scottish obstetric units, the reasons for any variation in its use and makes some suggestions as to the way forward based on the current literature.
Repeated 28-day oral toxicity study of vinclozolin in rats based on the draft protocol for the "Enhanced OECD Test Guideline No. 407" to detect endocrine effects. [2016]We performed a 28-day repeated-dose toxicity study of vinclozolin, a widely used fungicide, based on the draft protocol of the "Enhanced OECD Test Guideline 407" (Enhanced TG407) to investigate whether vinclozolin has endocrine-mediated properties according to this assay. Seven-week-old SD rats were administered with vinclozolin daily by oral gavage at dose rates of 0, 3.125, 12.5, 50 and 200 mg/kg/day for at least 28 days. The vinclozolin-treated male rats showed a reduction of epididymis and accessory sex organ weights and an alteration of hormonal patterns. A slight prolongation of the estrous cycle and changes in the estrogen/testosterone ratio and luteinizing hormone level were observed in vinclozolin-treated female rats. Thyroxin concentrations were decreased and thyroid-stimulating hormone concentrations were increased in both sexes; however, there were no compound-related microscopic lesions in the thyroid gland or changes in the thyroid weight. The endocrine-related effects of vinclozolin could be detected by the parameters examined in the present study based on the OECD protocol, suggesting the Enhanced TG407 protocol should be a suitable screening test for the detection of endocrine-mediated effects of chemicals.
Regulation of endocrine-disrupting chemicals: critical overview and deficiencies in toxicology and risk assessment for human health. [2006]Regulation of endocrine-disrupting chemicals is reviewed in terms of hazard assessment (regulatory toxicology) and risk assessment. The current range of regulatory general toxicology protocols can detect endocrine toxicity, but specific endocrine toxicology tests are required to confirm mechanisms (e.g. oestrogenic, anti-androgenic). Strategies for validating new endocrine toxicology protocols and approaches to data assessment are discussed, and deficiencies in regulatory toxicology testing (e.g. lack of adrenocortical function assessment) identified. Recent evidence of a role of prolactin in human breast cancer also highlights deficiencies in regulatory evaluation. Actual human exposure to chemicals and the high-exposure example of chemicals in body-care cosmetics is reviewed with reference to evidence that common ingredients (e.g. parabens, cyclosiloxanes) are oestrogenic. The hypothesis and epidemiology concerning chemical exposure from body-care cosmetics (moisturizers, lotions, sun screens, deodorants) and breast cancer in women is reviewed, applying Bradford-Hill criteria for association and causality, and research requirements are identified.
Oxytocin nasal spray in fibromyalgic patients. [2021]Fibromyalgia is a pain disorder associated with frequent comorbid mood, anxiety, and sleep disorders. Despite the frequent use of a complex, poly-drug pharmacotherapy, treatment for fibromyalgia is of limited efficacy. Oxytocin has been reported to reduce the severity of pain, anxiety, and depression, and improve the quality of sleep, suggesting that it may be useful to treat fibromyalgia. To evaluate this hypothesis, 14 women affected by fibromyalgia and comorbid disorders, assuming a complex pharmacotherapy, were enrolled in a double-blind, crossover, randomized trial to receive oxytocin and placebo nasal spray daily for 3 weeks for each treatment. Order of treatment (placebo-oxytocin or oxytocin-placebo) was randomly assigned. Patients were visited once a week. At each visit, the following instruments were administered: an adverse drug reaction record card, Visual Analog Scale of Pain Intensity, Spielberger State Anxiety Inventory, Zung Self-rating Depression Scale, and SF-12. Women self-registered painkiller assumption, pain severity, and quality of sleep in a diary. Unlikely, oxytocin nasal spray (80 IU a day) did not induce positive therapeutic effects but resulted to be safe, devoid of toxicity, and easy to handle.
Recommended approaches to the scientific evaluation of ecotoxicological hazards and risks of endocrine-active substances. [2018]A SETAC Pellston Workshop® "Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA)" was held in February 2016 in Pensacola, Florida, USA. The primary objective of the workshop was to provide advice, based on current scientific understanding, to regulators and policy makers; the aim being to make considered, informed decisions on whether to select an ecotoxicological hazard- or a risk-based approach for regulating a given endocrine-disrupting substance (EDS) under review. The workshop additionally considered recent developments in the identification of EDS. Case studies were undertaken on 6 endocrine-active substances (EAS-not necessarily proven EDS, but substances known to interact directly with the endocrine system) that are representative of a range of perturbations of the endocrine system and considered to be data rich in relevant information at multiple biological levels of organization for 1 or more ecologically relevant taxa. The substances selected were 17α-ethinylestradiol, perchlorate, propiconazole, 17β-trenbolone, tributyltin, and vinclozolin. The 6 case studies were not comprehensive safety evaluations but provided foundations for clarifying key issues and procedures that should be considered when assessing the ecotoxicological hazards and risks of EAS and EDS. The workshop also highlighted areas of scientific uncertainty, and made specific recommendations for research and methods-development to resolve some of the identified issues. The present paper provides broad guidance for scientists in regulatory authorities, industry, and academia on issues likely to arise during the ecotoxicological hazard and risk assessment of EAS and EDS. The primary conclusion of this paper, and of the SETAC Pellston Workshop on which it is based, is that if data on environmental exposure, effects on sensitive species and life-stages, delayed effects, and effects at low concentrations are robust, initiating environmental risk assessment of EDS is scientifically sound and sufficiently reliable and protective of the environment. In the absence of such data, assessment on the basis of hazard is scientifically justified until such time as relevant new information is available. Integr Environ Assess Manag 2017;13:267-279. © 2017 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).
Sex-specific effects of intranasal oxytocin on thermal pain perception: A randomised, double-blind, placebo-controlled cross-over study. [2018]Chronic neck and shoulder pain (CNSP) is a common musculoskeletal disorder in adults, which is linked to hypersensitivity to noxious stimuli. The hormone oxytocin has been implicated as a potential therapeutic for the management of chronic pain disorders, and has been suggested to have sex-specific effects on the salience of threatening stimuli. This study investigated the influence of intranasal oxytocin on the perception of noxious thermal stimuli. Participants were 24 individuals with CNSP lasting >12months (eight women), and 24 age- and sex-matched healthy, pain-free controls. In a randomised double-blind, placebo-controlled, cross-over study, participants attended two sessions, self-administering intranasal oxytocin (24 IU) in one session, and placebo in another. Participants rated intensity and unpleasantness of thermal heat stimuli at three body sites: the cervical spine, deltoid, and tibialis anterior, on 11-point numerical rating scales. Compared with placebo, intranasal oxytocin increased the perceived intensity of noxious heat stimuli in women with CNSP (Cohen's d=0.71), but not in men with CNSP, or healthy, pain-free controls. Men and women displayed divergent sensitivity across target sites for ratings of pain intensity (partial eta squared=0.12) and pain unpleasantness (partial eta squared=0.24), irrespective of drug condition. Men were more sensitive at the cervical spine and deltoid, whereas women were more sensitive at the tibialis. These findings suggest that oxytocin and endogenous sex hormones may interact to influence the salience of noxious stimuli. The hyperalgesic effects of oxytocin in women suggest that caution should be taken when considering oxytocin in the management of chronic pain.
Update on Activities in Endocrine Disruptor Research and Policy. [2019]For nearly 15 years, the Endocrine Society has engaged in a coordinated effort to engage the issue of endocrine-disrupting chemicals (EDCs). This effort is based on an effective collaboration between scientists and physician members of the Endocrine Society and a competent and professional staff that supports membership efforts to study EDC actions and translate this knowledge to regulatory agencies. This is a brief history of these important efforts to inform the broad readership of Endocrinology.
The ED/TEG Indicator for the Identification of Endocrine Disrupting or Toxic Effects on Endocrine Glands of Crop Protection Products Used in Organic and Conventional Agriculture in France. [2021]Studying the human health impacts of pesticides and their endocrine disruptor (ED) effects is a public health concern. The aim of this study is to identify phytopharmaceutical active substances (PAS) that are an ED or are toxic on endocrine glands (TEG), and to propose an ED/TEG effect indicator. Five international official databases were analyzed to identify the occurrence of health outcomes for 458 PAS. Health outcomes targeting seven endocrine systems were selected. For each substance, the level of evidence of the collected information and the number of outcomes were used to affect a level of concern about ED/TEG effects. Among the substances studied, 10% had a global ED/TEG effect classified as 'high concern', 55% as 'medium concern', 9% as 'low concern', and 26% as 'unknown'. Ten of the high ED/TEG concern substances and 170 medium or low concern substances were licensed in 2018 in France. The outcomes were mainly on the reproductive organs, thyroid, and adrenal glands. Eight of the 41 biocontrol products studied were classified: 5 were 'high' or 'medium concern' and 3 had 'unknown effect'. Although the proposed ED/TEG indicator is not an official classification, it can be used as an epidemiological tool for classifying the occupational and environmental risks of substances in retrospective population studies and be useful for occupational health physicians.
Anti-nociceptive effects of oxytocin receptor modulation in healthy volunteers-A randomized, double-blinded, placebo-controlled study. [2021]There is increasing evidence for oxytocin as a neurotransmitter in spinal nociceptive processes. Hypothalamic oxytocinergic neurons project to the spinal dorsal horn, where they activate GABA-ergic inhibitory interneurons. The present study tested whether the long-acting oxytocin-analogue carbetocin has anti-nociceptive effects in multi-modal experimental pain in humans.
Evaluating the efficacy of intranasal oxytocin on pain and function among individuals who experience chronic pain: a protocol for a multisite, placebo-controlled, blinded, sequential, within-subjects crossover trial. [2022]Current treatments for chronic pain (eg, opioids) can have adverse side effects and rarely result in resolution of pain. As such, there is a need for adjuvant analgesics that are non-addictive, have few adverse side effects and are effective for pain management across several chronic pain conditions. Oxytocin is a naturally occurring hormone that has gained attention for its potential analgesic properties. The objective of this trial is to evaluate the efficacy of intranasal oxytocin on pain and function among adults with chronic pain.
Effects of intranasal oxytocin on pain perception among human subjects: A systematic literature review and meta-analysis. [2023]Oxytocin (OXT) is a peptide hormone produced in the hypothalamus that plays a neuromodulatory role in emotion, stress, and anxiety. Due to its multidimensional role, OXT is a promising target for therapeutic interventions to treat pain.