Study of Intranasal Oxytocin to Improve Sexual Well-Being in Adults with Arginine Vasopressin Deficiency and Healthy Adults

What this Trial Is About

Researchers are investigating whether intranasal oxytocin OXT can improve sexual well-being in patients with Arginine Vasopressin Deficiency AVP-D, a condition caused by disruption in the hypothalamic-pituitary axis leading to fluid balance issues and psychological symptoms such as anxiety, reduced empathy, and decreased sexual desire. This Phase 2 trial aims to address the psychosocial challenges faced by patients despite standard treatment with desmopressin, exploring the potential role of OXT, a hormone linked to social bonding and emotional regulation. The trial uses a randomized, double-blind, placebo-controlled, crossover design with two parts. Part A involves a 7-day treatment with either intranasal OXT 24 IU or placebo in patients with AVP-D and their partners, followed by self-assessments of sexual well-being and intimacy, with a 3-week washout between treatments. Part B evaluates the effects of a single OXT dose or placebo on sexual arousal, empathy, fear perception, and hormonal responses in both single and partnered patients and healthy controls during one clinical visit. Participants will complete various assessments including sexual satisfaction scales, psychological questionnaires, and hormonal and autonomic measures related to sexual arousal and stress responses. The study monitors changes before and after treatments in Part A and during a single assessment in Part B. The total participation duration varies by part, with Part A involving repeated measures over weeks and Part B involving a one-day clinical evaluation. The goal is to provide insight into how OXT may influence sexual and emotional well-being in AVP-D patients.

Effects of Intranasal Oxytocin on Sexual Well-Being in Patients With Arginine Vasopressin Deficiency and Healthy Controls