Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery

This study is testing if a nasal spray called oxytocin (TNX-1900) can help reduce pain and improve recovery after pituitary surgery. Researchers believe oxytocin might help by changing how your brain processes emotions and social experiences, which could affect pain. You might be able to join if you are between 30 and 75 years old, speak English, and need surgery for a pituitary lesion (a growth on your pituitary gland). Women must be post-menopausal (at least one year since your last period). The study will look at how much your pain changes after surgery and how much pain medication you use. The current recruitment status is unclear.

Study design: This is a randomized, double-blind, placebo-controlled study with 75 participants. This means participants will be randomly assigned to receive either a low dose of oxytocin, a high dose of oxytocin, or a placebo (a nasal spray with no active medicine), and neither you nor your doctors will know which one you are receiving.
What's involved: You would use a nasal spray daily for one week before surgery, on the day of surgery, and for one week after surgery. You will also complete surveys and have brain activity measurements (EEG/ERP) throughout the study.
Compensation: Not stated in the trial record.
Follow-up: Your pain levels and pain medication use will be monitored from before surgery up to 8 weeks after your last dose of the study medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery

Not Yet Recruiting

PHASE2Ages 30–75InterventionalTreatment

Yale University

~75 participants

Updated 2026-07-28 on ClinicalTrials.gov

What's tested:Oxytocin (Low dose)Oxytocin (High dose)Placebo (saline)

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS)

Measured over Pre-op up to 8 weeks after last drug administration

+1 more outcome measured

Conditions

Pain

Pituitary Surgery

Where it's being run

1 sites across 1 states

Connecticut1

Study leadership

S. Bulent Omay, MD · PRINCIPAL_INVESTIGATOR · Yale University
Helena Rutherford, PhD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

S. Bulent Omay, MD

[email protected]

203-737-6885

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age: Between 30 to 75 years old.

Consent: Ability to give informed consent.

Language: Proficiency in the English language.

Medical Condition: Diagnosed with a pituitary lesion requiring surgery.

Menopausal Status: Post-menopause for women (at least 1 year since last menstrual period).

Exclusion

Medication: Individuals on stable doses of psychotropic medication for at least the past six weeks are eligible, excluding those with changes in medication within that timeframe.

Neurological Conditions: A history of seizures, current use of anticonvulsants.

Pregnancy: Currently pregnant, currently lactating, or up to 1-year post partum.

Any history of renal impairment (serum creatinine \>1.2 x ULN)

Any history of hepatic impairment (AST and/or ALT \>2 x ULN)

Surgical History: Any history of previous pituitary surgery procedures

Subjects who require 24-hour coverage with NSAIDs, e.g., arthritis, should not be included in the study.

Any known hypersensitivity to TNX-1900

What this trial measures

Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS)Pre-op up to 8 weeks after last drug administration
The NPRS is a patient-reported tool used to assess pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).
Change in post-operative pain measured by monitoring of pain medication usagePre-op up to 8 weeks after last drug administration
Daily pain medication usage will be reported by participants leading up to surgery and after discharge. Daily pain medication usage will be reported through the participant's medical record during surgery and inpatient stay.

Trialytics