Identifying Oxytocin Deficiency in Adults With Pituitary Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-13

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Arginine Vasopressin Deficiency Oxytocin Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study Model description: In this open-labeled, interventional pilot trial, 16 adults with arginine-vasopressin deficiency and 16 healthy controls balanced for age, sex, and body mass index will be recruited

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arginine-vasopressin deficiency

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

Group Type EXPERIMENTAL

Norethindrone Acetate-Ethinyl Estradiol

Intervention Type DRUG

Estrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort.

Healthy control

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

Group Type EXPERIMENTAL

Norethindrone Acetate-Ethinyl Estradiol

Intervention Type DRUG

Estrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort.

Interventions

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Norethindrone Acetate-Ethinyl Estradiol

Estrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort.

Intervention Type DRUG

Other Intervention Names

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Estrogen-progestin

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes