Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency
Recruiting now · Not applicable
Conditions studied: AVP Deficiency, Diabetes Insipidus
In brief
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.
Key facts
- Study ID
- NCT07361263
- Run by
- University Hospital, Basel, Switzerland
- People needed
- 28
- Starts
- 2026-01-09
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-01-23
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University Hospital Basel — Basel, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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