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New treatment option for AVP Deficiency
Official title Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency
ClinicalTrials.gov ID: NCT07361263
What this study is testing
What is estradiol valerate?
estradiol valerate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for avp deficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Part 1
- 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 Part 2
- Confirmed diagnosis of AVP-Deficiency
You likely can't join if
- Part 1
- 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
- Consumption of alcoholic beverages \>15 drinks/week
See the full eligibility criteria
- Part 1
- 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 Part 2
- Confirmed diagnosis of AVP-Deficiency
- Age ≥ 18 years
- 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
- Part 1
- 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
- Consumption of alcoholic beverages \>15 drinks/week
- Tobacco smoking \>10 cigarettes/day
- Pregnancy and breastfeeding
- Hormonal contraception
- Migraine with and without aura
- Any cardiometabolic, cardiovascular, and hematological diseases (including deep vein thrombosis/pulmonary embolism and thrombophilia (DVT/PE))
- Active liver dysfunction or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
- Diagnosed chronic kidney disease (CKD) \> grade III (GRF \< 30ml/min) Part 2
- 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
- Consumption of alcoholic beverages \>15 drinks/week
- Tobacco smoking \>10 cigarettes/day
- Pregnancy and breastfeeding
- Hormonal contraception
- Migraine with and without aura
- Any cardiometabolic, cardiovascular, and hematological diseases (including DVT/PE and Thrombophilia)
- Active liver dysfunction or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
- Diagnosed CKD \> grade III (GRF \< 30ml/min)
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.