๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ10 points and an NSSS-S score โค 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 โฅ10 points and an NSSS-S score โค 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)
๐
What it tests
- Oxytocin nasal spray
- Placebo
University Hospital Basel
Basel, Switzerland
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.