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

NCT06808516 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-02116; kt24ChristCrain4
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Arginine Vasopressin Deficiency; Central Diabetes Insipidus; Oxytocin Deficiency

Keywords

Nasal oxytocin; Sexual Well-Being

Outcome Measures

Primary Outcomes (2)

• Arizona Sexual Experience Scale (ASEX) (Part A)

  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

  before treatment and after the 7 day treatement period

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

  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

  before treatment and after the 7 day treatement period

Secondary Outcomes (17)

• 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

Study Arms (4)

Oxy part A: 7 Day treatment

EXPERIMENTAL

Syntocinon, 24 IU, administered over a 7 day period

Drug: Oxytocin nasal spray

Placebo part A: 7 Day treatment

PLACEBO COMPARATOR

0.9% sodium chloride, administered over a 7 day period

Drug: Placebo

Oxy part B: single application

EXPERIMENTAL

Syntocinon, 24 IU, administered once

Drug: Oxytocin nasal spray

Placebo Oxy part B: single application

PLACEBO COMPARATOR

0.9% sodium chloride, administered once

Drug: Placebo

Interventions

Oxytocin nasal spray DRUG

24 IU

Also known as: Syntocinon

Oxy part A: 7 Day treatment; Oxy part B: single application

Placebo DRUG

0.9% NaCl

Placebo Oxy part B: single application; Placebo part A: 7 Day treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Diabetes Insipidus, Neurogenic

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Diabetes Insipidus; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mirjam Christ-Crain, Prof. MD

  Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirjam Christ-Crain, Prof. MD

CONTACT

+41 61 328 70 80; mirjam.christ-crain@usb.ch

Cemile Bathelt

CONTACT

+41 61 556 54 07; cemile.bathelt@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 5, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

CH (1)