NCT06808516·Phase 2·INTERVENTIONAL

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

Vasopressin Other Recruiting

Status

Recruiting

Phase

Phase 2

Enrollment

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Oxytocin nasal spray

24 IU

DRUG

Placebo

0.9% NaCl

Timeline

From registration to results.

First posted
Feb 5, 2025
Study start
Jul 1, 2025
Primary completion
Dec 2026
Study completion
Dec 2026
Results posted
Not reported
Registry updated
Oct 3, 2025

Outcomes

What the study measures.

Primary outcomes

Arizona Sexual Experience Scale (ASEX) (Part A)

Time frame · before treatment and after the 7 day treatement period

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

New Sexual Satisfaction Scale (NSSS-S) (Part A)

Time frame · before treatment and after the 7 day treatement period

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

Secondary outcomes

sexual well-being and intimacy in response to sexual intercourse assesssed by ASEX (Part A)

Time frame · before treatment and after the 7 day treatement period

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

sexual well-being and intimacy in response to sexual intercourse assesssed by NSSS-S (Part A)

Time frame · before treatment and after the 7 day treatement period

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

Subjective sexual satisfaction and intimacy of the respective partners (Part A)

Time frame · before treatment and after the 7 day treatement period

Levels of sexual satisfaction and intimacy using the short version of the New Sexual Satisfaction Scale (NSSS-S), completed by the partners.

Hormonal response to sexual intercourse (Part B)