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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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). This condition is characterized by polyuria and polydipsia, leading to significant disruptions in the body's fluid balance. Desmopressin, an AVP receptor analogue, is the standard treatment for AVP-D and effectively mitigates these physical symptoms.

However, patients with AVP-D frequently report residual psychological symptoms that remain unaddressed despite desmopressin therapy. These include impaired emotion recognition, reduced empathy, heightened anxiety, social interaction difficulties, and decreased sexual desire-all of which significantly affect their quality of life. Recent data from an international survey of over 1,000 patients with AVP-D reinforce these findings, highlighting the psychosocial burden of this condition.

Oxytocin (OXT), a neuropeptide closely associated with AVP in terms of anatomical location and function, is known to play a critical role in social, emotional, and behavioral regulation. As a "pro-social" hormone, OXT fosters trust, intimacy, attachment, and pair bonding, while also mitigating stress. The proximity of the AVP and OXT systems within the brain suggests that disruptions in one could potentially lead to deficiencies in the other. Supporting this hypothesis, recent research using a novel stimulation test with MDMA demonstrated an OXT deficiency in patients with AVP-D, offering a potential explanation for their observed psychopathology.

OXT's influence extends to sexual well-being, where it has been shown to enhance bonding, intimacy, and the emotional aspects of sexual relationships. Elevated OXT levels are observed during labor, lactation, and sexual arousal, and studies suggest correlations between OXT and orgasm intensity, sexual satisfaction, and partner attachment. While previous studies have examined OXT's effects on social and emotional behavior in healthy individuals, its therapeutic potential in addressing psychological and sexual well-being in AVP-D patients remains unexplored.

This study aims to investigate whether intranasal OXT administration can improve sexual well-being, intimacy, and pair bonding in patients with AVP-D. By addressing an unrecognized OXT deficiency, this research seeks to fill a critical gap in understanding and managing the psychosocial challenges associated with AVP-D.

The trial employs a randomized, double-blind, placebo-controlled, cross-over design and consists of two parts:

1. Part A involves a seven-day treatment with intranasal OXT (24 IU) or placebo in patients with AVP-D and their partners. Participants will self-assess their sexual well-being and intimacy at baseline and after each treatment period, with a three-week washout period between treatments.
2. Part B evaluates the acute effects of a single intranasal OXT dose (24 IU) or placebo on sexual arousal, empathy, fear perception, and hormonal responses to visual stimuli in both single and partnered patients with AVP-D, compared to healthy controls.

This comprehensive approach will provide insights into both the long-term and immediate impacts of OXT therapy, with the ultimate goal of improving quality of life for patients with AVP-D.

Conditions

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Arginine Vasopressin Deficiency Central Diabetes Insipidus Oxytocin Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This randomized, placebo-controlled trial with a double-blind, cross-over design examines patients with AVP-D compared to healthy controls.

* Part A investigates the acute effects of intranasal OXT on sexual well-being and intimacy during intercourse over a seven-day treatment period in couples where one partner has AVP-D, compared to healthy couples. Using a cross-over design with a three-week washout aligned to the female participant's menstrual cycle, only couples in stable relationships are eligible. Participants complete self-evaluations at baseline and after each treatment period.
* Part B, conducted in a clinical setting, includes single participants and those in relationships. It assesses subjective sexual arousal, fear perception, empathy, and physical and hormonal responses to visual stimuli following intranasal OXT or placebo. Randomized participants receive a single application of OXT or placebo, with a 72-hour or three-week washout depending on study participation.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The OXT and placebo nasal spray will be identical in volume, labelling and container systems, so that they cannot be differentiated from one another. The placebo will contain no OXT but 0.9% normal saline.

Study Groups

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Oxy part A: 7 Day treatment

Syntocinon, 24 IU, administered over a 7 day period

Group Type EXPERIMENTAL

Oxytocin nasal spray

Intervention Type DRUG

24 IU

Placebo part A: 7 Day treatment

0.9% sodium chloride, administered over a 7 day period

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% NaCl

Oxy part B: single application

Syntocinon, 24 IU, administered once

Group Type EXPERIMENTAL

Oxytocin nasal spray

Intervention Type DRUG

24 IU

Placebo Oxy part B: single application

0.9% sodium chloride, administered once

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% NaCl

Interventions

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Oxytocin nasal spray

24 IU

Intervention Type DRUG

Placebo

0.9% NaCl

Intervention Type DRUG

Other Intervention Names

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Syntocinon

Eligibility Criteria

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Inclusion Criteria

* 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 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes