Informazioni generali
  • Categoria della malattia Malattie endocrinologiche (non cancro) (BASEC)
  • Stato di reclutamento reclutamento in corso (BASEC/ICTRP)
  • Luogo dello studio
    Basilea
    (BASEC)
  • Responsabile dello studio Mirjam Christ-Crain mirjam.christ-crain@usb.ch (BASEC)
  • Fonte dati BASEC: Importato da 06.08.2026 ICTRP: N/A
  • Ultimo aggiornamento 06.08.2026 09:05
HumRes67585 | SNCTP000006701 | BASEC2025-02197

Oral Estradiol Valerate and Ethinylestradiol as a Stimulation Test for Possible Oxytocin Deficiency in Patients with Vasopressin Deficiency and Healthy Control Subjects

  • Categoria della malattia Malattie endocrinologiche (non cancro) (BASEC)
  • Stato di reclutamento reclutamento in corso (BASEC/ICTRP)
  • Luogo dello studio
    Basilea
    (BASEC)
  • Responsabile dello studio Mirjam Christ-Crain mirjam.christ-crain@usb.ch (BASEC)
  • Fonte dati BASEC: Importato da 06.08.2026 ICTRP: N/A
  • Ultimo aggiornamento 06.08.2026 09:05

Descrizione riassuntiva dello studio

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)

Intervento studiato

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)

Malattie studiate

Vasopressin deficiency (formerly diabetes insipidus)

(BASEC)

Criteri di partecipazione

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)


Criteri di esclusione

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)

Luogo dello studio

Basilea

(BASEC)

non disponibile

Sponsor

Prof Dr med Mirjam Christ-Crain Universitätsspital Basel Departement Endokrinologie, Diabetologie und Metabolismus

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Mirjam Christ-Crain

+41 61 265 25 25

mirjam.christ-crain@usb.ch

Universitätsspital Basel

(BASEC)

Informazioni scientifiche

non disponibile

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica svizzera nord-ovest/centrale EKNZ

(BASEC)

Data di approvazione del comitato etico

01.12.2025

(BASEC)


ID di studio ICTRP
non disponibile

Titolo ufficiale (approvato dal comitato etico)
Plasma Oxytocin in Response to Oral Estradiol Valerate and Ethinylestradiol in Healthy Controls and Patients with AVP-Deficiency (BASEC)

Titolo accademico
non disponibile

Titolo pubblico
non disponibile

Malattie studiate
non disponibile

Intervento studiato
non disponibile

Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
non disponibile

non disponibile

Endpoint primari e secondari
non disponibile

non disponibile

Data di registrazione
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Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
non disponibile

ID secondari
non disponibile

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
non disponibile

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile