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RecruitingPhase 2NCT06808516

Effects of Intranasal Oxytocin on Sexual Well-Being in Patients With Arginine Vasopressin Deficiency and Healthy Controls

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

Sponsor

University Hospital, Basel, Switzerland

Enrollment

42 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Inclusion Criteria9

  • 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

Exclusion Criteria5

  • 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)

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Interventions

DRUGOxytocin nasal spray

24 IU

DRUGPlacebo

0.9% NaCl

Locations(1)

University Hospital Basel

Basel, Switzerland

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NCT06808516