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
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
Crossover
Oxytocin nasal spray
Drug24 IU
Placebo
Drug0.9% NaCl
Arizona Sexual Experience Scale (ASEX) (Part A)
Subjective improvement in sexual well-being and intimacy, defined as a score decrease of 3 or more points on the ASEX (score range: 5-30). Only assessed in Part A
New Sexual Satisfaction Scale (NSSS-S) (Part A)
Subjective improvement in sexual well-being and intimacy, with an increase of 3 or more points on the NSSS-S (score range: 12-60). Only assessed in Part A
sexual well-being and intimacy in response to sexual intercourse assesssed by ASEX (Part A)
sexual well-being and intimacy in response to sexual intercourse assesssed by ASEX (score range: 5-30, while 30 indicates higher well-being). Comparison of success rates in the primary endpoint between patients with AVP-D and healthy controls
sexual well-being and intimacy in response to sexual intercourse assesssed by NSSS-S (Part A)
sexual well-being and intimacy in response to sexual intercourse assesssed by NSSS-S (score range: 12-60, while 60 indicates higher well-being). Comparison of success rates in the primary endpoint between patients with AVP-D and healthy controls
Subjective sexual satisfaction and intimacy of the respective partners (Part A)
Levels of sexual satisfaction and intimacy using the short version of the New Sexual Satisfaction Scale (NSSS-S), completed by the partners.
Hormonal response to sexual intercourse (Part B)
Area under the salivary cortisol concentration curves in response to sexual Intercourse
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