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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07730294
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Pain
  • Pituitary Surgery

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Oxytocin (Low dose) — DRUG
    The dosage for low -dose intranasal oxytocin is set at 6 International Units (IU) per day, divided into two administrations of 3IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
  • Oxytocin (High dose) — DRUG
    The dosage for high-dose intranasal oxytocin is set at 24 International Units (IU) per day, divided into two administrations of 12 IU each per nostril. The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
  • Placebo (saline) — DRUG
    Placebo nasal spray (no study medication, magnesium only). The administration begins one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.

Study Details

This study is testing whether oxytocin can help lessen pain by changing how people process emotions and social experiences. The goal is to better understand how the brain links emotions, relationships, and pain, and whether this connection can be used to improve pain treatment.

Key Dates

First listed
Jul 28, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Dose Oxytocin
    Participants in this arm will receive low dose oxytocin beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
  • Experimental: High Dose Oxytocin
    Participants in this arm will receive high dose oxytocin beginning one week prior to surgery, continues on the day of the surgery, and extends through the week following the surgery.
  • Placebo Comparator: Saline-Mg solution
    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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510
S. Bulent Omay, MD
[email protected]
203-737-6885
Helena Rutherford, PhD
[email protected]
S. Bulent Omay, MD (PRINCIPAL_INVESTIGATOR)
Helena Rutherford, PhD (PRINCIPAL_INVESTIGATOR)

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Yale University· New Haven, CT

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