Clinical trial NCT06808516: Effects of Intranasal Oxytocin on Sexual Well-Being in Patients With Arginine Vasopressin Deficiency and Healthy Controls
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Arginine Vasopressin Deficiency
Central Diabetes Insipidus
Oxytocin Deficiency
Keywords: Nasal oxytocin
Sexual Well-Being
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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)

Primary outcomes:
measure: Arizona Sexual Experience Scale (ASEX) (Part A)
timeFrame: before treatment and after the 7 day treatement period
measure: New Sexual Satisfaction Scale (NSSS-S) (Part A)
timeFrame: before treatment and after the 7 day treatement period
Secondary outcomes:
measure: sexual well-being and intimacy in response to sexual intercourse assesssed by ASEX (Part A)
timeFrame: before treatment and after the 7 day treatement period
measure: sexual well-being and intimacy in response to sexual intercourse assesssed by NSSS-S (Part A)
timeFrame: before treatment and after the 7 day treatement period
measure: Subjective sexual satisfaction and intimacy of the respective partners (Part A)
timeFrame: before treatment and after the 7 day treatement period
measure: Hormonal response to sexual intercourse (Part B)
timeFrame: at the day of assessement, 2.5 hours
measure: Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B)
timeFrame: at the day of assessement, 2.5 hours
measure: Subjective sexual arousal, emotional empathy, fear and fear-induced stress (PANAS) (Part B)
timeFrame: at the day of assessement, 2.5 hours
measure: Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (SADI)
timeFrame: at the day of assessement, 2.5 hours
measure: Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (TEQ)
timeFrame: at the day of assessement, 2.5 hours
measure: Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (STAI-S)
timeFrame: at the day of assessement, 2.5 hours
measure: Autonomic response to sexual arousal and to acute fear-induced stress (Part B) (HR)
timeFrame: during the one day assessment, 2.5 hours
measure: Autonomic response to sexual arousal and to acute fear-induced stress (Part B) (BP)
timeFrame: during the one day assessment, 2.5 hours
measure: Hormonal response to sexual arousal, emotional empathy and acute fear-induced stress (Part B)
timeFrame: during the one day assessment, 2.5 hours
measure: Psychological measures (PFB)
timeFrame: assessed on study inclusion at the baseline visit
measure: Psychological measures (SDI-2)
timeFrame: assessed on study inclusion at the baseline visit
measure: Psychological measures (SBQ-G)
timeFrame: assessed on study inclusion at the baseline visit
measure: Psychological measures (STAI-S)
timeFrame: assessed on study inclusion at the baseline visit
measure: Psychological measures (TEQ)
timeFrame: assessed on study inclusion at the baseline visit
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Universitätsspital Basel
name: Mirjam Christ-Crain, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: