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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Arizona Sexual Experience Scale (ASEX) (Part A)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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)
研究组 & 干预措施
Oxy part A: 7 Day treatment
Syntocinon, 24 IU, administered over a 7 day period
干预措施: Oxytocin nasal spray (Drug)
Placebo part A: 7 Day treatment
0.9% sodium chloride, administered over a 7 day period
干预措施: Placebo (Drug)
Oxy part B: single application
Syntocinon, 24 IU, administered once
干预措施: Oxytocin nasal spray (Drug)
Placebo Oxy part B: single application
0.9% sodium chloride, administered once
干预措施: Placebo (Drug)
结局指标
主要结局
Arizona Sexual Experience Scale (ASEX) (Part A)
时间窗: 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)
时间窗: 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
次要结局
- sexual well-being and intimacy in response to sexual intercourse assesssed by ASEX (Part A)(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)(before treatment and after the 7 day treatement period)
- Subjective sexual satisfaction and intimacy of the respective partners (Part A)(before treatment and after the 7 day treatement period)
- Hormonal response to sexual intercourse (Part B)(at the day of assessement, 2.5 hours)
- Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B)(at the day of assessement, 2.5 hours)
- Subjective sexual arousal, emotional empathy, fear and fear-induced stress (PANAS) (Part B)(at the day of assessement, 2.5 hours)
- Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (SADI)(at the day of assessement, 2.5 hours)
- Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (TEQ)(at the day of assessement, 2.5 hours)
- Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (STAI-S)(at the day of assessement, 2.5 hours)
- Autonomic response to sexual arousal and to acute fear-induced stress (Part B) (HR)(during the one day assessment, 2.5 hours)
- Autonomic response to sexual arousal and to acute fear-induced stress (Part B) (BP)(during the one day assessment, 2.5 hours)
- Hormonal response to sexual arousal, emotional empathy and acute fear-induced stress (Part B)(during the one day assessment, 2.5 hours)
- Psychological measures (PFB)(assessed on study inclusion at the baseline visit)
- Psychological measures (SDI-2)(assessed on study inclusion at the baseline visit)
- Psychological measures (SBQ-G)(assessed on study inclusion at the baseline visit)
- Psychological measures (STAI-S)(assessed on study inclusion at the baseline visit)
- Psychological measures (TEQ)(assessed on study inclusion at the baseline visit)
