๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ 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)