Effects of Intranasal Oxytocin on Sexual Well-Being in Patients With Arginine Vasopressin Deficiency and Healthy Controls
NCT06808516
Summary
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.
Eligibility
Inclusion Criteria for healthy controls: * 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 Inclusion criteria for patients: * 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 Exclusion Criteria: * Pregnancy and breastfeeding within the last eight weeks * Participation in a trial with investigational drugs within 30 days * Active substance use disorder within the last six months * Consumption of alcoholic beverages \>15 drinks/week * Current or previous psychotic disorder (e.g., schizophrenia)
Conditions4
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NCT06808516