Identifying Oxytocin Deficiency in Adults With Pituitary Disease

Elizabeth Austen Lawson

Status and phase: Enrolling; Early Phase 1

Conditions: Arginine Vasopressin Deficiency; Oxytocin Deficiency

Treatments: Drug: Norethindrone Acetate-Ethinyl Estradiol

Study type: Interventional

Funder types: Other

Identifiers

NCT06460948

2024P001090

Details and patient eligibility

About

This is an open-label, pilot study, to characterize oxytocin response to a single dose of oral Estrogen-progestin in patients with arginine-vasopressin deficiency compared to healthy controls. The association between oxytocin levels and measures of psychopathology (i.e., anxiety and depression) and quality of life across groups will be examined. We hypothesize that:

1. Salivary and blood oxytocin response to Estrogen-progestin will be lower in arginine-vasopressin deficiency compared to healthy control.
2. Lower salivary and blood oxytocin levels will be associated with more severe symptoms of anxiety, depression, and social emotional difficulties as well as lower quality of life.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• AVD Group:

Adults 18-65 years old Arginine-vasopressin deficiency Stable pituitary hormone replacement

• Healthy Control Group Adults 16-65 years old

Exclusion Criteria for all participants:

• History of pulmonary embolism, deep vein thrombosis, breast/endometrial cancer, stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral artery disease
• Pregnancy or breastfeeding within last 8 weeks
• Any significant illness or condition that the investigator determines could interfere with study participation, data collection, or safety

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Arginine-vasopressin deficiency

Experimental group

Description:

Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency

Treatment:

Drug: Norethindrone Acetate-Ethinyl Estradiol

Healthy control

Experimental group

Description:

Norethindrone Acetate-Ethinyl Estradiol will be given to the healthy controls.

Treatment:

Drug: Norethindrone Acetate-Ethinyl Estradiol