A Phase 2/3 interventional study of Intranasal Oxytocin and Placebo in Chronic Pain and Pelvic Pain, sponsored by University of Calgary. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University of Calgary · Phase 2/3, Interventional, and Treatment
This study is a placebo-controlled, double-blind, within-participants crossover investigation of the effect of intranasal oxytocin on pain and function among women with chronic pelvic pain.
Rationale: Oxytocin (OT) is a neuropeptide produced in the supraoptic and paraventricular nuclei of the hypothalamus. There exists at least three plausible mechanisms through which OT may decrease pain sensitivity. In brief, the first mechanism involves spinal signaling. A direct hypothalamo-spinal projection originating from the paraventricular nucleus transports OT, to the dorsal horn (Lamina-I, II, and IV), an area containing OT receptors that influence glutamate and GABA cellular signaling. The second mechanism involves an indirect pathway via the endogenous opioids. Evidence suggests that OT binds to opioid receptors and may also stimulate endogenous opioid release in the brain. Finally, OT may decrease pain by improving mood, decreasing anxiety, and mitigating the stress response.
Thirty-three animal investigations have assessed OT-pain relationships with 29 reporting that exogenous administration and higher endogenous levels decreased pain. There is a lack of clarity of an OT-pain association in the human literature due to a paucity of methodologically rigorous trials. Thus far, OT administration has been reported to lower pain sensitivity among patients experiencing chronic back pain, headache, constipation, and colon pain. To date, no research has evaluated the association between intranasal OT and chronic pelvic pain. The association between OT and pain may be different in women with pelvic pain relative to other chronic pain conditions because of a potential peripheral OT-pain pathway. There is an abundance of OT receptors in the uterus, and OT is a potent uterogenic agent that is clinically used in large doses to stimulate uterine contractions and induce labor. While OT does not cross the blood-brain-barrier, the central administration of intranasal OT increases central and blood-plasma OT concentrations. Thus, intranasal OT administration may be associated with pain through central and peripheral pathways; however uterine contractions with 24IU doses of intranasal OT occur in only 1 in every 100-1000 people.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
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Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Exclusion Criteria:
Oxytocin nasal spray delivered bi-daily over a 14-day period at 24-IU per dose
Drug: Intranasal Oxytocin
Placebo nasal spray containing the same ingredients as the active nasal spray minus the oxytocin and packaged in an identical bottle. To be delivered bi-daily over a 14-day period at 24-IU per dose
Drug: Placebo
Intranasal oxytocin (Syntocinon; Novartis, Switzerland)
Also known as: Syntocinon
Placebo nasal spray
Self-reported pain
The Brief Pain Inventory - Short Form
Time frame: 14-days
Self-report positive and negative affect
Positive and Negative Affect Scale
Time frame: 14-days
Self-report depressed mood, anxious mood, and stress
Depression Anxiety Stress Scale
Time frame: 14-day
Self-report sleep
Medical Outcomes Study Sleep Scale
Time frame: 14-day
Plan to share: Undecided
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of Calgary