Actively Recruiting
Plasma Oxytocin Response to Oral Estradiol Valerate and Ethinylestradiol in Healthy Controls and Patients With AVP Deficiency
Led by University Hospital, Basel, Switzerland · Updated on 2026-01-23
28
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether oral estradiol valerate (EV) and ethinylestradiol (EE) can stimulate the release of oxytocin (OXT) and neurophysin-1 (NP-1) in humans. The study aims to find a safer diagnostic test for oxytocin deficiency, especially in patients with arginine vasopressin (AVP) deficiency, who may experience psychological symptoms related to OXT deficiency. This research includes healthy adults and patients with AVP deficiency to compare responses to these estrogen compounds. The study has two parts: Part 1 is a randomized, double-blind, cross-over trial with healthy adults to compare how EV and EE affect plasma OXT and NP-1 levels. Part 2 is an open-label trial involving patients with AVP deficiency, where the most effective estrogen compound from Part 1 will be tested to see if their OXT and NP-1 responses differ from healthy controls. Participants receive oral doses and are monitored over a 300-minute period. Participants will undergo blood and saliva sampling at multiple time points up to 300 minutes after dosing to measure changes in plasma oxytocin, neurophysin-1, coagulation parameters, endocrine hormones, and vital signs. Emotional effects, anxiety levels, and emotion recognition are also assessed through questionnaires and tasks at various intervals. Safety and adverse effects are closely monitored, and data collection includes measurements of plasma sodium and potassium levels. Total participation duration varies by study part.
CONDITIONS
Brief Title
Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 50 years
- Healthy controls with no medication including hormonal contraception for Part 1
- Female participants (except post-menopausal) with a regular menstrual cycle of 21-35 days in the last 6 months for Part 1
- Confirmed diagnosis of AVP deficiency for Part 2
- Female participants (except post-menopausal) with a regular cycle or a 1-week pause from hormone replacement therapy for Part 2
You will not qualify if you...
- Participation in another investigational drug trial within 30 days
- Body mass index (BMI) over 30
- Age over 50 years
- Illicit substance use (except cannabis) within the last 30 days
- Consuming 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 elevated liver enzymes (ALAT or ASAT) more than 2.5 times normal
- Chronic kidney disease grade III or worse (glomerular filtration rate below 30 ml/min)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single-day dosing visits separated by washout periods
Participants receive oral doses of estradiol valerate and ethinylestradiol in a randomized crossover design to evaluate plasma oxytocin and neurophysin-1 responses.
2 treatment visits (in-person)
Duration - Up to 24 hours post-dose per treatment visit
Participants undergo post-dose assessments including emotional effects, vital parameters, and hormone level monitoring up to 24 hours after dosing.
Follow-up assessments during each treatment visit
Trial Site Locations
Total: 1 location
1
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
A
Andi Nikaj, MD
U
Ursula Gobrecht-Keller, MD
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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