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New treatment option for Arginine Vasopressin Deficiency
Official title Effects of Intranasal Oxytocin on Sexual Well-Being in Patients With Arginine Vasopressin Deficiency and Healthy Controls
ClinicalTrials.gov ID: NCT06808516
What this study is testing
What is Oxytocin nasal spray?
Oxytocin nasal spray is an investigational medicine, being studied as a potential treatment for arginine vasopressin deficiency.
Also referred to as Syntocinon.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- for healthy controls:
- 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
You likely can't join 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)
See the full eligibility criteria
- for healthy controls:
- 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 for patients:
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.