Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency
Recruiting
N/AInterventional Study
AVP DeficiencyDiabetes Insipidus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 50
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
28 (estimated)
Sponsor
University Hospital, Basel, Switzerland · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
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Eligibility Criteria
Inclusion Criteria:
Part 1
1. Adult healthy controls
2. No medication (including hormonal contraception)
3. Female patients (except post-menopausal): regular cycle (21-35 days of duration) in the last 6 months
Part 2
1. Confirmed diagnosis of AVP-Deficiency
2. Age ≥ 18 years
3. Female patients (…
Inclusion Criteria:
Part 1
1. Adult healthy controls
2. No medication (including hormonal contraception)
3. Female patients (except post-menopausal): regular cycle (21-35 days of duration) in the last 6 months
Part 2
1. Confirmed diagnosis of AVP-Deficiency
2. Age ≥ 18 years
3. Female patients (except post-menopausal): regular cycle (21-35 days of duration) in the last 6 months or in the case of hormone replacement therapy, with a 1-week pause from the respective treatment
Exclusion Criteria:
Part 1
1. Participation in a trial with investigational drugs within 30 days
2. BMI \>30
3. Age \>50
4. Illicit substance use (except for cannabis) during the last 30 days
5. Consumption of alcoholic beverages \>15 drinks/week
6. Tobacco smoking \>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/pulmonary embolism and thrombophilia (DVT/PE))
11. Active liver dysfunction or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
12. Diagnosed chronic kidney disease (CKD) \> grade III (GRF \< 30ml/min)
Part 2
1. Participation in a trial with investigational drugs within 30 days
2. BMI \>30
3. Age \>50
4. Illicit substance use (except for cannabis) during the last 30 days
5. Consumption of alcoholic beverages \>15 drinks/week
6. Tobacco smoking \>10 cigarettes/day
7. Pregnancy and breastfeeding
8. Hormonal contraception
9. Migraine with and without aura
10. Any cardiometabolic, cardiovascular, and hematological diseases (including DVT/PE and Thrombophilia)
11. Active liver dysfunction or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
12. Diagnosed CKD \> grade III (GRF \< 30ml/min)
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