Intranasal oxytocin for sexual well‑being in people with arginine vasopressin deficiency and matched healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.