Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency
Plasma Oxytocin in Response to Oral Estradiol Valerate and Ethinylestradiol in Healthy Controls and Patients With AVP-Deficiency
University Hospital, Basel, Switzerland
28 participants
Jan 9, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- Part 1
- Adult healthy controls
- No medication (including hormonal contraception)
- Female patients (except post-menopausal): regular cycle (21-35 days of duration) in the last 6 months
- Part 2
- Confirmed diagnosis of AVP-Deficiency
- Age ≥ 18 years
- 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 Criteria26
- Part 1
- Participation in a trial with investigational drugs within 30 days
- BMI >30
- Age >50
- Illicit substance use (except for cannabis) during the last 30 days
- Consumption of alcoholic beverages >15 drinks/week
- Tobacco smoking >10 cigarettes/day
- Pregnancy and breastfeeding
- Hormonal contraception
- Migraine with and without aura
- Any cardiometabolic, cardiovascular, and hematological diseases (including deep vein thrombosis/pulmonary embolism and thrombophilia (DVT/PE))
- Active liver dysfunction or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
- Diagnosed chronic kidney disease (CKD) > grade III (GRF < 30ml/min)
- Part 2
- Participation in a trial with investigational drugs within 30 days
- BMI >30
- Age >50
- Illicit substance use (except for cannabis) during the last 30 days
- Consumption of alcoholic beverages >15 drinks/week
- Tobacco smoking >10 cigarettes/day
- Pregnancy and breastfeeding
- Hormonal contraception
- Migraine with and without aura
- Any cardiometabolic, cardiovascular, and hematological diseases (including DVT/PE and Thrombophilia)
- Active liver dysfunction or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
- Diagnosed CKD > grade III (GRF < 30ml/min)
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Interventions
estradiol valerate
estradiol valerate
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07361263