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

What Was Tested

This registered phase 2 trial tested Oxytocin.

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.

It had four arms (groups): Oxy part A: 7 Day treatment (experimental), Placebo part A: 7 Day treatment (placebo comparator), Oxy part B: single application (experimental) and Placebo Oxy part B: single application (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Disruption of the hypothalamic-pituitary axis, caused by inflammation, tumors, or head trauma, can result in arginine vasopressin (AVP) deficiency (AVP-D), formerly known as central diabetes insipidus (cDI).

However, patients with AVP-D frequently report residual psychological symptoms that remain unaddressed despite desmopressin therapy.

Recent data from an international survey of over 1,000 patients with AVP-D reinforce these findings, highlighting the psychosocial burden of this condition.

As a "pro-social" hormone, OXT fosters trust, intimacy, attachment, and pair bonding, while also mitigating stress.

Who Took Part

Enrollment: 42 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 9 inclusion and 5 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-07-01 with completion listed for 2026-12.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Arizona Sexual Experience Scale (ASEX) (Part A) (time frame: before treatment and after the 7 day treatement period). New Sexual Satisfaction Scale (NSSS-S) (Part A) (time frame: before treatment and after the 7 day treatement period).

It also tracked 17 secondary outcomes, for example sexual well-being and intimacy in response to sexual intercourse assesssed by ASEX (Part A), sexual well-being and intimacy in response to sexual intercourse assesssed by NSSS-S (Part A), Subjective sexual satisfaction and intimacy of the respective partners (Part A), Hormonal response to sexual intercourse (Part B), Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) and Subjective sexual arousal, emotional empathy, fear and fear-induced stress (PANAS) (Part B).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 42 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.