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

What Was Tested

The trial (phase 2) is built around Oxytocin.

This study is testing whether oxytocin can help lessen pain by changing how people process emotions and social experiences.

It had three arms (groups): one (experimental), one (experimental) and Saline-Mg solution (placebo comparator).

Participants in this arm will receive placebo beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.

The registry classes the interventions as drug.

More on the Plan

Participants will administer their nasal spray (blinded) daily for 7 days leading up to, and including the day of surgery, and 7 days following the surgery.

Assessments (surveys and EEG/ERP) will be included throughout the protocol.

Who Took Part

Enrollment: 75 planned participants were the target.

It was open to people of any sex aged from 30 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: 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).

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-08 with completion listed for 2028-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in post-operative pain measured by the Numeric Pain Rating Scale (NPRS) (time frame: Pre-op up to 8 weeks after last drug administration). Change in post-operative pain measured by monitoring of pain medication usage (time frame: Pre-op up to 8 weeks after last drug administration).

It also tracked 5 secondary outcomes, for example Changes in participant reported depression as measured by the Beck Depression Inventory (BDI-II), Changes in participant reported anxiety as measured by the Beck Anxiety Inventory (BAI), Changes in participant reported anxiety as measured by the Generalized Anxiety Disorder-7, Changes in participant reported depression as measured by the Patient Health Questionnaire-9 and Change in neural functioning measured by Electroencephalography (EEG)/Event-Related Potential (ERP).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 75 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.