Identifying Oxytocin Deficiency in Adults With Pituitary Disease

Last updated: February 7, 2025
Sponsor: Elizabeth Austen Lawson
Overall Status: Active - Recruiting

Phase

1

Condition

Hormone Deficiencies

Treatment

Norethindrone Acetate-Ethinyl Estradiol

Clinical Study ID

NCT06460948
2024P001090
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Norethindrone Acetate-Ethinyl Estradiol
Phase: 1
Study Start date:
November 13, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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