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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Central Diabetes Insipidus; Oxytocin Deficiency; Arginine Vasopressin Deficiency
• Intervention / Treatment: Drug: Placebo; Drug: Oxytocin nasal spray

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mirjam Christ-Crain, Prof. MD; Phone Number: +41 61 328 70 80; Email: mirjam.christ-crain@usb.ch
• Study Contact Backup: Name: Cemile Bathelt; Phone Number: +41 61 556 54 07; Email: cemile.bathelt@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Contact: Cemile Bathelt; Phone Number: +41 61 556 54 07; Email: cemile.bathelt@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxy part A: 7 Day treatment; Syntocinon, 24 IU, administered over a 7 day period	Drug: Oxytocin nasal spray; 24 IU; Other Names: Syntocinon
Placebo Comparator: Placebo part A: 7 Day treatment; 0.9% sodium chloride, administered over a 7 day period	Drug: Placebo; 0.9% NaCl
Experimental: Oxy part B: single application; Syntocinon, 24 IU, administered once	Drug: Oxytocin nasal spray; 24 IU; Other Names: Syntocinon
Placebo Comparator: Placebo Oxy part B: single application; 0.9% sodium chloride, administered once	Drug: Placebo; 0.9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arizona Sexual Experience Scale (ASEX) (Part A)	Subjective improvement in sexual well-being and intimacy, defined as a score decrease of 3 or more points on the ASEX (score range: 5-30). Only assessed in Part A	before treatment and after the 7 day treatement period
New Sexual Satisfaction Scale (NSSS-S) (Part A)	Subjective improvement in sexual well-being and intimacy, with an increase of 3 or more points on the NSSS-S (score range: 12-60). Only assessed in Part A	before treatment and after the 7 day treatement period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 ASEX (score range: 5-30, while 30 indicates higher well-being). Comparison of success rates in the primary endpoint between patients with AVP-D and healthy controls	before treatment and after the 7 day treatement period
sexual well-being and intimacy in response to sexual intercourse assesssed by NSSS-S (Part A)	sexual well-being and intimacy in response to sexual intercourse assesssed by NSSS-S (score range: 12-60, while 60 indicates higher well-being). Comparison of success rates in the primary endpoint between patients with AVP-D and healthy controls	before treatment and after the 7 day treatement period
Subjective sexual satisfaction and intimacy of the respective partners (Part A)	Levels of sexual satisfaction and intimacy using the short version of the New Sexual Satisfaction Scale (NSSS-S), completed by the partners.	before treatment and after the 7 day treatement period
Hormonal response to sexual intercourse (Part B)	Area under the salivary cortisol concentration curves in response to sexual Intercourse	at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B)	Numeric Rating Scales for sexual arousal. Score ranges from 0-75 while 0 indicates minimal sexual arousal	at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (PANAS) (Part B)	Positive and Negative Affect Schedule (PANAS). Score ranges from 10-50 while higher values represent a greater degree of positive affect.	at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (SADI)	Sexual Arousal and Desire Inventory (SADI); Score ranges from 0-75 while lower scores indicate minimal sexual arousal	at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (TEQ)	Toronto Empathy Questionnaire (TEQ); Score ranges from 0-64 - Higher scores indicate high levels of self-reported empathy while scores below 45 are indicative of below average empathy levels	at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (STAI-S)	State-Anxiety Scale (STAI-S). Total score ranges from 0-40, with higher scores indicating more pronounced anxiety. A score of 20 suggests clinically significant anxiety symptoms.	at the day of assessement, 2.5 hours
Autonomic response to sexual arousal and to acute fear-induced stress (Part B) (HR)	heart rate measurement	during the one day assessment, 2.5 hours
Autonomic response to sexual arousal and to acute fear-induced stress (Part B) (BP)	blood pressure measurement	during the one day assessment, 2.5 hours
Hormonal response to sexual arousal, emotional empathy and acute fear-induced stress (Part B)	Time course of plasma cortisol, oxytocin, neurophysin I, copeptin, prolactin and ACTH levels in response to visual stimuli with erotic, horror and social-positive content	during the one day assessment, 2.5 hours
Psychological measures (PFB)	Level of quality of the partnership using the Partnership Questionnaire (PFB). Total score ranges from 0-90; a total score of 54 is considered the threshold for a satisfactory partnership	assessed on study inclusion at the baseline visit
Psychological measures (SDI-2)	Level of interest in sexual activity using the Sexual Desire Inventory (SDI-2). Total score ranges from 0-78, Dyadic Score : 0-38 & Solitary Score: 0- 40 , higher scores indicating more desire	assessed on study inclusion at the baseline visit
Psychological measures (SBQ-G)	Level of sexual (dys-)functions using the Sexual Behavior Questionnaire (SBQ-G). Women: 10 items, Men: 11 items; Range: 1-4, with a higher range indicating greater sexual function and desire. Mean Global Index: Sum of 5 items/5 (Median: 2)	assessed on study inclusion at the baseline visit
Psychological measures (STAI-S)	Level of trait anxiety using the State-Anxiety Scale (STAI-S). 20 items, Total score ranges from 0-40, with higher scores indicating more pronounced anxiety. A score of 20 suggests clinically significant anxiety symptoms.	assessed on study inclusion at the baseline visit
Psychological measures (TEQ)	Level of emotional empathy using the Toronto Empathy Questionnaire (TEQ). Score ranges from 0-64 while higher scores indicate high levels of self-reported empathy while scores below 45 are indicative of below average empathy levels	assessed on study inclusion at the baseline visit

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Mirjam Christ-Crain, Prof. MD, Universitatsspital Basel

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Nasal oxytocin; Sexual Well-Being
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pituitary Diseases; Diabetes Insipidus; Diabetes Insipidus, Neurogenic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pituitary Hormones, Posterior; Pituitary Hormones; Oxytocin
• Other Study ID Numbers: 2024-02116; kt24ChristCrain4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No