Intranasal oxytocin for sexual well‑being in people with arginine vasopressin deficiency and matched healthy adults
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
This trial will test whether a nasal oxytocin spray can improve sexual well‑being, arousal, intimacy and related emotions in adults with arginine vasopressin deficiency and in matched healthy adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT06808516 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial compares intranasal oxytocin with placebo using patient‑reported and clinical measures. Part A gives daily intranasal treatment for 7 days to partnered, sexually active participants to measure effects on sexual well‑being and intimacy. Part B gives a single dose in a clinical setting to evaluate effects on sexual arousal, fear, and empathy in single participants and those in partnerships. Participants include adults with confirmed AVP deficiency on stable desmopressin replacement and matched healthy controls meeting specified ASEX and NSSS‑S thresholds, and all visits take place at the University Hospital Basel.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with confirmed arginine vasopressin deficiency on stable desmopressin replacement or matched healthy volunteers who report at least mild sexual dysfunction (ASEX ≥10 and NSSS‑S ≤48), with Part A requiring a stable partnership and regular sexual activity.
Not a fit: People without sexual or intimacy complaints, those not on stable hormone replacement, or those with contraindications to intranasal treatments are unlikely to gain benefit from this intervention.
Why it matters
Potential benefit: If successful, intranasal oxytocin could provide a targeted way to improve sexual desire, intimacy and social‑emotional functioning for people with AVP‑D who still have psychosocial symptoms despite desmopressin.
How similar studies have performed: Previous small studies of intranasal oxytocin have shown mixed effects on social bonding and sexual behaviors, and its use specifically in AVP‑D is exploratory with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Mirjam Christ-Crain, Prof. MD — Universitätsspital Basel
- Study coordinator: Mirjam Christ-Crain, Prof. MD
- Email: mirjam.christ-crain@usb.ch
- Phone: +41 61 328 70 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.