Informazioni generali
  • Categoria della malattia Malattie endocrinologiche (non cancro) (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Basilea
    (BASEC)
  • Responsabile dello studio Mirjam Christ-Crain mirjam.christ-crain@usb.ch (BASEC)
  • Fonte dati BASEC: Importato da 17.04.2025 ICTRP: N/A
  • Ultimo aggiornamento 17.04.2025 09:00
HumRes66755 | SNCTP000006370 | BASEC2024-02116

Effect of Oxytocin on Sexual Well-Being and Intimacy in Patients with Vasopressin Deficiency [Central Diabetes Insipidus] and Healthy Controls

  • Categoria della malattia Malattie endocrinologiche (non cancro) (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Basilea
    (BASEC)
  • Responsabile dello studio Mirjam Christ-Crain mirjam.christ-crain@usb.ch (BASEC)
  • Fonte dati BASEC: Importato da 17.04.2025 ICTRP: N/A
  • Ultimo aggiornamento 17.04.2025 09:00

Descrizione riassuntiva dello studio

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)

Intervento studiato

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)

Malattie studiate

Patients with Vasopressin Deficiency (Central Diabetes Insipidus)

(BASEC)

Criteri di partecipazione
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)

Criteri di esclusione
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)

Luogo dello studio

Basilea

(BASEC)

non disponibile

Sponsor

Mirjam Christ-Crain

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Mirjam Christ-Crain

0612652525

mirjam.christ-crain@usb.ch

Dept. of Endocrinology, Metabolism & Diabetes University Hospital Basel Petersgraben 4 4031 Basel

(BASEC)

Informazioni scientifiche

non disponibile

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica svizzera nord-ovest/centrale EKNZ

(BASEC)

Data di approvazione del comitato etico

03.01.2025

(BASEC)


ID di studio ICTRP
non disponibile

Titolo ufficiale (approvato dal comitato etico)
Effects of intranasal Oxytocin on Sexual Well-Being in Patients with Arginine Vasopressin Deficiency (central Diabetes insipidus) and Healthy Controls- the OxyPLEASURE Study (BASEC)

Titolo accademico
non disponibile

Titolo pubblico
non disponibile

Malattie studiate
non disponibile

Intervento studiato
non disponibile

Tipo di studio
non disponibile

Disegno dello studio
non disponibile

Criteri di inclusione/esclusione
non disponibile

non disponibile

Endpoint primari e secondari
non disponibile

non disponibile

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
non disponibile

ID secondari
non disponibile

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
non disponibile


Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile