Effect of Oxytocin on Sexual Well-Being and Intimacy in Patients with Vasopressin Deficiency [Central Diabetes Insipidus] and Healthy Controls
Summary description of the study
Patients with a vasopressin deficiency (central diabetes insipidus) suffer from a lack of the antidiuretic hormone vasopressin. These patients produce a high amount of urine and must compensate for this fluid loss with a high intake of fluids. Desmopressin, a medication similar to vasopressin, can be used to treat this condition. Despite treatment with desmopressin, patients often report symptoms such as increased anxiety, reduced trust, a lower sense of closeness and security, decreased sexual desire, and an overall reduced quality of life. A recent study has shown that these patients lack not only the hormone vasopressin but also the hormone oxytocin. In the brain, oxytocin is produced in the same area as vasopressin and released from the pituitary gland. The hormone is involved in important positive psychosocial aspects such as building trust, closeness, and love, has anxiolytic effects, positively influences sensations such as relaxation, and enhances empathy. This hormone is therefore also referred to as the cuddle, love, or loyalty hormone. The observed psychological changes in patients could therefore be partially explained by this additional oxytocin deficiency. In this study, we investigate whether the administration of the study medication oxytocin over a period of one week leads to an improvement in sexual well-being and intimacy in patients. This includes sexual arousal, orgasm ability, sexual satisfaction, and partner bonding.
(BASEC)
Intervention under investigation
This study is a so-called cross-over study, meaning all participants will receive a placebo on two study days and oxytocin as a nasal spray on two study days. The order of the study days is determined randomly. The placebo contains no active ingredient and is thus a 'dummy medication'. After the preliminary examination, a total of four study appointments will take place:
• On two of these study days at home, the effect of the sprays on your sexual arousal, satisfaction, and intimacy after sexual interaction will be investigated.
• On the other two study days on-site, specific emotions such as sexual arousal, empathy, and stress/anxiety will be tested in response to various film clips.
(BASEC)
Disease under investigation
Patients with Vasopressin Deficiency (Central Diabetes Insipidus)
(BASEC)
Inclusion Criteria for Healthy Controls 1. Healthy volunteers 2. Same age, gender, BMI, and menopause/hormonal contraception as the patients. 3. No medications, except hormonal contraception Patients: 1. Confirmed diagnosis of AVP deficiency according to established criteria 2. Stable hormone therapy for at least three months with desmopressin and, in cases of additional anterior pituitary insufficiencies, with the corresponding substitution therapies 3. At least a mild impairment of sexual function and satisfaction, defined as an ASEX score of ≥10 points and an NSSS-S score of ≤48 points (BASEC)
Exclusion criteria
1. Pregnancy and breastfeeding within the last eight weeks 2. Active substance use disorder within the last six months 3. Consumption of alcoholic beverages >15 drinks/week 4. Acute or previous psychotic disorder (e.g., schizophrenia) 5. Prolonged QTc interval (>470ms) in a 12-lead electrocardiogram (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
Mirjam Christ-Crain
(BASEC)
Contact
Contact Person Switzerland
Mirjam Christ-Crain
0612652525
mirjam.christ-crain@clutterusb.chDept. of Endocrinology, Metabolism & Diabetes University Hospital Basel Petersgraben 4 4031 Basel
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
03.01.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Effects of intranasal Oxytocin on Sexual Well-Being in Patients with Arginine Vasopressin Deficiency (central Diabetes insipidus) and Healthy Controls- the OxyPLEASURE Study (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available