Actively Recruiting
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
Led by University Hospital, Basel, Switzerland · Updated on 2025-10-03
42
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Effects of Intranasal Oxytocin on Sexual Well-Being in Patients With Arginine Vasopressin Deficiency and Healthy Controls
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and above
- For healthy controls: matched for age, sex, BMI, and menopause/hormonal contraceptives to patients
- No medication except hormonal contraception (for healthy controls)
- At least mild impairment in sexual function and satisfaction defined as ASEX score 6510 and NSSS-S score 64 48
- For Part A: sexually active with at least once a week sexual intercourse and in a current partnership for at least 6 months
- For patients: confirmed diagnosis of AVP deficiency based on established criteria
- Stable hormone replacement therapy for at least 3 months with desmopressin and other substitutions if applicable
You will not qualify if you...
- Pregnancy or 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 more than 15 alcoholic drinks per week
- Current or previous psychotic disorder such as schizophrenia
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days per treatment period with a 3-week washout between treatments
Participants receive intranasal oxytocin or placebo to assess effects on sexual well-being and intimacy, including a 7-day treatment period followed by a 3-week washout and a crossover to the alternate treatment.
2 treatment periods with baseline and post-treatment assessments for each
Duration - Single day
Participants receive a single intranasal dose of oxytocin or placebo to evaluate acute effects on sexual arousal, empathy, fear perception, and hormonal responses during the same day.
1 assessment visit lasting approximately 2.5 hours
Trial Site Locations
Total: 1 location
1
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
M
Mirjam Christ-Crain, Prof. MD
C
Cemile Bathelt
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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