Oral Estradiol Valerate and Ethinylestradiol as a Stimulation Test for Possible Oxytocin Deficiency in Patients with Vasopressin Deficiency and Healthy Control Subjects
Summary description of the study
This study investigates whether the intake of estrogen (Estradiol Valerate or Ethinylestradiol) increases the oxytocin level in the blood. Oxytocin is a hormone associated with emotional regulation and water balance in the body. A deficiency of oxytocin could lead to psychological symptoms such as anxiety and depression in people with a hormone deficiency known as AVP deficiency.
Study Objective:
To examine whether the intake of estrogen (Estradiol Valerate or Ethinylestradiol) increases the oxytocin level in healthy individuals but not in patients with AVP deficiency. This could be a new test for diagnosing oxytocin deficiency.
Study Procedure:
Part 1 (healthy adults):
Double-blind, randomized study
Participants will take either 6mg of Estradiol Valerate (Progynova®) or 30mcg of Ethinylestradiol (Elyfem®) on two study days.
Part 2 (patients with AVP deficiency):
Open study without blinding
Participants will take either 6mg of Estradiol Valerate or 30mcg of Ethinylestradiol, whichever caused a greater increase in oxytocin in healthy subjects.
Expectation:
It is expected that estrogen will increase the oxytocin level in healthy adults but not in individuals with AVP deficiency.
(BASEC)
Intervention under investigation
Part 1 (healthy adults):
Intake of 6mg of Estradiol Valerate (Progynova®) and 30mcg of Ethinylestradiol (Elyfem®) with at least a one-week interval (double-blind crossover).
Part 2 (patients with AVP deficiency):
Open study without blinding
Intake of either 6mg of Estradiol Valerate or 30mcg of Ethinylestradiol, whichever caused a greater increase in oxytocin in healthy subjects.
(BASEC)
Disease under investigation
Vasopressin deficiency (formerly diabetes insipidus)
(BASEC)
Part 1: Healthy subjects
1. Healthy adults as control group
2. No medication (including hormonal contraceptives)
3. Female patients (except postmenopausal): regular cycle (21-35 days duration) in the last 6 months
Part 2: Pilot study in patients with AVP deficiency
1. Confirmed diagnosis of AVP deficiency
2. Age ≥ 18 years
3. Female patients (except postmenopausal): regular cycle (21-35 days duration) in the last 6 months or in the case of hormone replacement therapy with a 1-week break from the respective treatment
(BASEC)
Exclusion criteria
Exclusion criteria for healthy subjects and patients with AVP deficiency:
1. Participation in a study with investigational drugs within the last 30 days
2. BMI > 30
3. Age > 50 years
4. Use of illegal substances (except cannabis) within the last 30 days
5. Consumption of alcoholic beverages > 15 drinks/week
6. Tobacco use > 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 (DVT)/pulmonary embolism (PE) and thrombophilia)
11. Active liver dysfunction or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than 2.5 times the normal range
12. Diagnosed chronic kidney disease (CKD) > Grade III (GFR < 30 ml/min)
(BASEC)
Trial sites
Basel
(BASEC)
Sponsor
Prof Dr med Mirjam Christ-Crain Universitätsspital Basel Departement Endokrinologie, Diabetologie und Metabolismus
(BASEC)
Contact
Contact Person Switzerland
Mirjam Christ-Crain
+41 61 265 25 25
mirjam.christ-crain@clutterusb.chUniversitätsspital Basel
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
01.12.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Plasma Oxytocin in Response to Oral Estradiol Valerate and Ethinylestradiol in Healthy Controls and Patients with AVP-Deficiency (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available