Effects of Oral Estradiol Valerate and Ethinylestradiol on Oxytocin and Neurophysin-1 Levels in Adults With and Without AVP Deficiency

What this Trial Is About

Researchers are evaluating whether oral estradiol valerate EV and ethinylestradiol EE can stimulate the release of oxytocin OXT and neurophysin-1 NP-1 in humans. The study aims to develop a safe diagnostic test for oxytocin deficiency, especially in patients with arginine vasopressin AVP deficiency, a condition linked to water balance and emotional regulation issues. Patients with AVP deficiency may suffer psychological symptoms possibly related to oxytocin deficiency, and current tests using MDMA have limitations due to side effects. The study includes two parts Part 1 is a randomized, double-blind, crossover trial in healthy adults comparing the effects of EV and EE on plasma OXT and NP-1 levels. Participants receive one oral estrogen formulation, followed by a washout period before crossing over to the other treatment. Part 2 is an open-label trial in patients with AVP deficiency, who receive the most effective estrogen identified from Part 1 to assess whether their OXT and NP-1 responses differ from healthy controls. Participants will undergo blood and saliva sampling before and up to 300 minutes after dosing to measure changes in plasma oxytocin, neurophysin-1, coagulation parameters, endocrine hormones, and vital signs. Emotional effects and anxiety levels will be assessed through questionnaires and tasks at multiple time points. Safety and adverse effects will be monitored, with the total participation spanning the dosing day and follow-up assessments over 24 hours.

Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency