Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency
Trial Parameters
Brief Summary
The PHOENIX study aims to investigate whether oral estradiol valerate (EV) and ethinylestradiol (EE) can stimulate oxytocin (OXT) and neurophysin-1 (NP-1) release in humans. The goal is to assess their potential as a safe diagnostic stimulation test for oxytocin deficiency, particularly in patients with arginine vasopressin (AVP) deficiency.
Eligibility Criteria
Inclusion Criteria: Part 1 1. Adult healthy controls 2. No medication (including hormonal contraception) 3. Female patients (except post-menopausal): regular cycle (21-35 days of duration) in the last 6 months Part 2 1. Confirmed diagnosis of AVP-Deficiency 2. Age ≥ 18 years 3. Female patients (except post-menopausal): regular cycle (21-35 days of duration) in the last 6 months or in the case of hormone replacement therapy, with a 1-week pause from the respective treatment Exclusion Criteria: Part 1 1. Participation in a trial with investigational drugs within 30 days 2. BMI \>30 3. Age \>50 4. Illicit substance use (except for cannabis) during the last 30 days 5. Consumption of alcoholic beverages \>15 drinks/week 6. Tobacco smoking \>10 cigarettes/day 7. Pregnancy and breastfeeding 8. Hormonal contraception 9. Migraine with and without aura 10. Any cardiometabolic, cardiovascular, and hematological diseases (including deep vein thrombosis/pulmonary embolism and thrombophilia (DVT/PE)