How oral estrogens affect blood oxytocin in healthy people and those with AVP deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial first randomizes healthy adult women in a double-blind, cross-over design to receive oral estradiol valerate and ethinylestradiol while measuring plasma oxytocin and neurophysin-1 responses. The estrogen that produces the larger oxytocin response in healthy participants is then given open-label to adults with confirmed AVP-deficiency to see if their hormonal response is blunted compared with controls. Women must meet menstrual-cycle or treatment-washout criteria and the protocol excludes participants with pregnancy, breastfeeding, hormonal contraception, high BMI, significant cardiovascular or thrombotic risk, or recent investigational drug use. The approach aims to identify a safer, practical stimulation test for oxytocin deficiency as an alternative to MDMA-based provocation.

Why it matters

Who can join: the full rules

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)

Where it's running

• University Hospital Basel
  Basel, Switzerland Recruiting

Study contacts

• Study coordinator: Andi Nikaj, MD
• Email: andi.nikaj@usb.ch
• Phone: +41 61 328 57 43

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.