Identifying oxytocin deficiency in adults with pituitary disease
Characterizing Oxytocin Response to Oral Estrogen Administration in Adults With Arginine Vasopressin Deficiency
This study is testing how a single dose of hormone therapy affects oxytocin levels in adults with a specific pituitary condition to see if it relates to their anxiety, depression, and overall quality of life compared to healthy individuals.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06460948 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the oxytocin response to a single dose of oral Estrogen-progestin in adults with arginine-vasopressin deficiency compared to healthy controls. It will measure salivary and blood oxytocin levels and assess their association with symptoms of anxiety, depression, and quality of life. The study hypothesizes that individuals with arginine-vasopressin deficiency will exhibit lower oxytocin responses and more severe psychological symptoms than healthy participants.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 with arginine-vasopressin deficiency who are on stable pituitary hormone replacement.
Not a fit: Patients with a history of significant cardiovascular or cancer-related conditions, or those who are pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and treatment options for patients with pituitary disease and associated psychological conditions.
How similar studies have performed: While this approach is novel in its specific focus on oxytocin response in this patient population, similar studies have explored hormonal influences on psychological conditions with varying degrees of success.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth A Lawson, MD — Massachusetts General Hospital
- Study coordinator: Francesca Galbiati, MD
- Email: fgalbiati@bwh.harvard.edu
- Phone: 617-726-3870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.