Identifying Oxytocin Deficiency in Adults With Pituitary Disease
Purpose
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.
Conditions
- Arginine Vasopressin Deficiency
- Oxytocin Deficiency
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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 Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arginine-vasopressin deficiency |
Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency |
|
|
Experimental Healthy control |
Norethindrone Acetate-Ethinyl Estradiol will be given to the healthy controls. |
|
Recruiting Locations
Boston, Massachusetts 02114
Francesca Galbiati, MD
More Details
- Status
- Recruiting
- Sponsor
- Elizabeth Austen Lawson