Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Confirmed diagnosis of AVP-Deficiency
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
estradiol valerate
Drugestradiol valerate
esthinylestradiol
Drugestradiol valerate
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Study Part IExperimental treatment 2 interventions
Group B: Study Part IIExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Relative Change in Plasma Oxytocin
The primary endpoint is the relative change in plasma oxytocin (OXT) concentrations (pg/mL respectively pM) from baseline to the maximum observed value within 300 minutes after administration of oral estradiol valerate (EV) or ethinylestradiol (EE). Baseline is defined as 100% of the initial pre-dose concentration.
Time frame
From baseline (0 min) to 300 minutes post-dose.2
Relative Change in Neurophysin-1
The primary endpoint is the relative change in neurophysin-1 (NP-1) concentrations (pg/mL respectively pM) from baseline to the maximum observed value within 300 minutes after administration of oral estradiol valerate (EV) or ethinylestradiol (EE). Baseline is defined as 100% of the initial pre-dose concentration.
Time frame
From baseline (0 min) to 300 minutes post-dose.Secondary outcomes
1
Area Under the Curve (AUC) for Plasma OXT and NP-1
Time frame
From baseline (0 min) to 300 minutes post-dose.2
Peak change in plasma OXT/NP-1 levels
Time frame
From baseline (0 min) to 300 minutes post-dose.3
Time course of plasma OXT/NP-1 levels
Time frame
From baseline (0 min) to 300 minutes post-dose.4
Changes in Coagulation Parameters: time course (von Willebrand factor)
Time course and peak of coagulation marker von Willebrand factor
Time frame
From baseline (0 min) to 300 minutes post-dose.Sponsors and contacts
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Source ClinicalTrials.gov