The OxyPLEASURE Study - Effects of Intranasal Oxytocin on Sexual Well-Being in Patients With Arginine Vasopressin Deficiency (Central Diabetes Insipidus) and Healthy Controls - a Double-blind Randomized Placebo-controlled Crossover Trial
The study aims to investigate whether intranasal oxytocin (OXT) improves sexual well-being in patients with Arginine Vasopressin Deficiency (AVP-D). The trial consists of two parts: Part A assesses the effect of OXT on sexual well-being and intimacy over a 7-day treatment period in participants in a stable partnership. Part B assesses the effect of a single dose OXT on sexual arousal, fear and empathy in a clinical setting and is designed for single participants and those in partnerships.
• Adult healthy volunteers aged 18 years and above
• Matched for age, sex, BMI, and menopause/hormonal contraceptives to patients
• No medication, except hormonal contraception
• At least mild impairment in sexual function and satisfaction, defined as an ASEX-score ≥10 points and an NSSS-S score ≤ 48 points
• Only Part A: Participants must be sexually active (at least once a week sexual intercourse) and in a current partnership for at least 6 months
• Adult patients aged 18 years and above, with a confirmed diagnosis of AVP deficiency based on established criteria
• Stable hormone replacement therapy for at least three months with desmopressin and, in case of additional anterior pituitary deficiencies, with the respective substitution therapies
• At least mild impairment in sexual function and satisfaction, defined as an ASEX-score ≥10 points and an NSSS-S score ≤ 48 points
• Only Part A: Participants must be sexually active (at least once a week sexual intercourse) and in a current partnership for at least 6 months