Actively Recruiting
Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency
Led by University Hospital, Basel, Switzerland · Updated on 2026-01-23
28
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult healthy controls without medication including hormonal contraception (Part 1)
- Female participants (except post-menopausal) with regular menstrual cycles (21-35 days) in the last 6 months (Part 1)
- Confirmed diagnosis of AVP-Deficiency (Part 2)
- Age 18 years or older (Part 2)
- Female participants (except post-menopausal) with regular menstrual cycles (21-35 days) in the last 6 months, or if on hormone replacement therapy, with a 1-week pause from treatment (Part 2)
You will not qualify if you...
- Participation in a trial with investigational drugs within the past 30 days
- Body mass index (BMI) over 30
- Age over 50 years
- Illicit substance use (except cannabis) in the last 30 days
- Consumption of more than 15 alcoholic drinks per week
- Smoking more than 10 cigarettes per day
- Pregnancy or breastfeeding
- Use of hormonal contraception
- Migraine with or without aura
- Any cardiometabolic, cardiovascular, or hematological diseases including deep vein thrombosis, pulmonary embolism, or thrombophilia
- Active liver dysfunction or liver enzyme levels (ALAT or ASAT) 2.5 times above normal
- Diagnosed chronic kidney disease grade III or higher (glomerular filtration rate below 30 ml/min)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
A
Andi Nikaj, MD
CONTACT
U
Ursula Gobrecht-Keller, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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