Arginine Vasopressin DeficiencyPhase 2OxyPLEASURENCT06808516
Effects of Intranasal Oxytocin on Sexual Well-Being in Patients With Arginine Vasopressin Deficiency and Healthy Controls
A Phase 2 study testing Oxytocin nasal spray in people with Arginine Vasopressin Deficiency and Central Diabetes Insipidus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arginine Vasopressin Deficiency, Central Diabetes Insipidus, Oxytocin Deficiency
- What is being tested?
- Oxytocin nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Cemile Bathelt, +41 61 556 54 07, cemile.bathelt@usb.ch
About this study
Official title: 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
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.
Read the detailed description
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.
The trial employs a randomized, double-blind, placebo-controlled, cross-over design and consists of two parts:
- Part A involves a seven-day treatment with intranasal OXT (24 IU) or placebo in patients with AVP-D and their partners. Participants will self-assess their sexual well-being and intimacy at baseline and after each treatment period, with a three-week washout period between treatments.
- Part B evaluates the acute effects of a single intranasal OXT dose (24 IU) or placebo on sexual arousal, empathy, fear perception, and hormonal responses to visual stimuli in both single and partnered patients with AVP-D, compared to healthy controls.
This comprehensive approach will provide insights into both the long-term and immediate impacts of OXT therapy, with the ultimate goal of improving quality of life for patients with AVP-D.
- Being tested
- Oxytocin nasal spray, Placebo
- Keywords
- Nasal oxytocin, Sexual Well-Being
- Medical subject headings
- Diabetes Insipidus, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Also called Syntocinon
24 IU
PlaceboDrug
0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| Oxy part A: 7 Day treatment | Experimental | Syntocinon, 24 IU, administered over a 7 day period Receives: Drug: Oxytocin nasal spray |
| Placebo part A: 7 Day treatment | Placebo comparator | 0.9% sodium chloride, administered over a 7 day period Receives: Drug: Placebo |
| Oxy part B: single application | Experimental | Syntocinon, 24 IU, administered once Receives: Drug: Oxytocin nasal spray |
| Placebo Oxy part B: single application | Placebo comparator | 0.9% sodium chloride, administered once Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
sexual well-being and intimacy in response to sexual intercourse assesssed by ASEX (score range: 5-30, while 30 indicates higher well-being). Comparison of success rates in the primary endpoint between patients with AVP-D and healthy controls
Measured: 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)
sexual well-being and intimacy in response to sexual intercourse assesssed by NSSS-S (score range: 12-60, while 60 indicates higher well-being). Comparison of success rates in the primary endpoint between patients with AVP-D and healthy controls
Measured: before treatment and after the 7 day treatement period
Subjective sexual satisfaction and intimacy of the respective partners (Part A)
Levels of sexual satisfaction and intimacy using the short version of the New Sexual Satisfaction Scale (NSSS-S), completed by the partners.
Measured: before treatment and after the 7 day treatement period
Hormonal response to sexual intercourse (Part B)
Area under the salivary cortisol concentration curves in response to sexual Intercourse
Measured: at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B)
Numeric Rating Scales for sexual arousal. Score ranges from 0-75 while 0 indicates minimal sexual arousal
Measured: at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (PANAS) (Part B)
Positive and Negative Affect Schedule (PANAS). Score ranges from 10-50 while higher values represent a greater degree of positive affect.
Measured: at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (SADI)
Sexual Arousal and Desire Inventory (SADI); Score ranges from 0-75 while lower scores indicate minimal sexual arousal
Measured: at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (TEQ)
Toronto Empathy Questionnaire (TEQ); Score ranges from 0-64 - Higher scores indicate high levels of self-reported empathy while scores below 45 are indicative of below average empathy levels
Measured: at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (STAI-S)
State-Anxiety Scale (STAI-S). Total score ranges from 0-40, with higher scores indicating more pronounced anxiety. A score of 20 suggests clinically significant anxiety symptoms.
Measured: at the day of assessement, 2.5 hours
Autonomic response to sexual arousal and to acute fear-induced stress (Part B) (HR)
heart rate measurement
Measured: during the one day assessment, 2.5 hours
Autonomic response to sexual arousal and to acute fear-induced stress (Part B) (BP)
blood pressure measurement
Measured: during the one day assessment, 2.5 hours
Hormonal response to sexual arousal, emotional empathy and acute fear-induced stress (Part B)
Time course of plasma cortisol, oxytocin, neurophysin I, copeptin, prolactin and ACTH levels in response to visual stimuli with erotic, horror and social-positive content
Measured: during the one day assessment, 2.5 hours
Psychological measures (PFB)
Level of quality of the partnership using the Partnership Questionnaire (PFB). Total score ranges from 0-90; a total score of 54 is considered the threshold for a satisfactory partnership
Measured: assessed on study inclusion at the baseline visit
Psychological measures (SDI-2)
Level of interest in sexual activity using the Sexual Desire Inventory (SDI-2). Total score ranges from 0-78, Dyadic Score : 0-38 \& Solitary Score: 0- 40 , higher scores indicating more desire
Measured: assessed on study inclusion at the baseline visit
Psychological measures (SBQ-G)
Level of sexual (dys-)functions using the Sexual Behavior Questionnaire (SBQ-G). Women: 10 items, Men: 11 items; Range: 1-4, with a higher range indicating greater sexual function and desire. Mean Global Index: Sum of 5 items/5 (Median: 2)
Measured: assessed on study inclusion at the baseline visit
Psychological measures (STAI-S)
Level of trait anxiety using the State-Anxiety Scale (STAI-S). 20 items, Total score ranges from 0-40, with higher scores indicating more pronounced anxiety. A score of 20 suggests clinically significant anxiety symptoms.
Measured: assessed on study inclusion at the baseline visit
Psychological measures (TEQ)
Level of emotional empathy using the Toronto Empathy Questionnaire (TEQ). Score ranges from 0-64 while higher scores indicate high levels of self-reported empathy while scores below 45 are indicative of below average empathy levels
Measured: assessed on study inclusion at the baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arginine Vasopressin DeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof. MD, Principal investigator, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808516
- Sponsor's protocol ID
- 2024-02116; kt24ChristCrain4
- Acronym
- OxyPLEASURE
- Status last verified
- Sep 2025
- First submitted
- 28 Jan 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06808516
- Acronym / sponsor ID
- OxyPLEASURE / 2024-02116; kt24ChristCrain4
- Keywords
- Nasal oxytocin, Sexual Well-Being
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The trial employs a randomized, double-blind, placebo-controlled, cross-over design and consists of two parts:
- Part A involves a seven-day treatment with intranasal OXT (24 IU) or placebo in patients with AVP-D and their partners. Participants will self-assess their sexual well-being and intimacy at baseline and after each treatment period, with a three-week washout period between treatments.
- Part B evaluates the acute effects of a single intranasal OXT dose (24 IU) or placebo on sexual arousal, empathy, fear perception, and hormonal responses to visual stimuli in both single and partnered patients with AVP-D, compared to healthy controls.
This comprehensive approach will provide insights into both the long-term and immediate impacts of OXT therapy, with the ultimate goal of improving quality of life for patients with AVP-D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oxy part A: 7 Day treatment | Experimental | Drug: Oxytocin nasal spraySyntocinon, 24 IU, administered over a 7 day period |
| Placebo part A: 7 Day treatment | Placebo comparator | Drug: Placebo0.9% sodium chloride, administered over a 7 day period |
| Oxy part B: single application | Experimental | Drug: Oxytocin nasal spraySyntocinon, 24 IU, administered once |
| Placebo Oxy part B: single application | Placebo comparator | Drug: Placebo0.9% sodium chloride, administered once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin nasal sprayAlso: Syntocinon24 IU | Drug | Oxy part A: 7 Day treatment, Oxy part B: single application |
| Placebo0.9% NaCl | Drug | Placebo Oxy part B: single application, Placebo part A: 7 Day treatment |
Primary outcome
Arizona Sexual Experience Scale (ASEX) (Part A)
Time frame: 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)
Time frame: 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
17 secondary outcomes
sexual well-being and intimacy in response to sexual intercourse assesssed by ASEX (Part A)
Time frame: 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)
Time frame: before treatment and after the 7 day treatement period
Subjective sexual satisfaction and intimacy of the respective partners (Part A)
Time frame: before treatment and after the 7 day treatement period
Hormonal response to sexual intercourse (Part B)
Time frame: at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B)
Time frame: at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (PANAS) (Part B)
Time frame: at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (SADI)
Time frame: at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (TEQ)
Time frame: at the day of assessement, 2.5 hours
Subjective sexual arousal, emotional empathy, fear and fear-induced stress (Part B) (STAI-S)
Time frame: at the day of assessement, 2.5 hours
Autonomic response to sexual arousal and to acute fear-induced stress (Part B) (HR)
Time frame: during the one day assessment, 2.5 hours
Autonomic response to sexual arousal and to acute fear-induced stress (Part B) (BP)
Time frame: during the one day assessment, 2.5 hours
Hormonal response to sexual arousal, emotional empathy and acute fear-induced stress (Part B)
Time frame: during the one day assessment, 2.5 hours
Psychological measures (PFB)
Time frame: assessed on study inclusion at the baseline visit
Psychological measures (SDI-2)
Time frame: assessed on study inclusion at the baseline visit
Psychological measures (SBQ-G)
Time frame: assessed on study inclusion at the baseline visit
Psychological measures (STAI-S)
Time frame: assessed on study inclusion at the baseline visit
Psychological measures (TEQ)
Time frame: assessed on study inclusion at the baseline visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
Related trials for Arginine Vasopressin Deficiency
RecruitingPhase 1
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Vasopressin Deficiency
RecruitingEarly Phase 1
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Arginine Vasopressin Deficiency, Oxytocin Deficiency
Recruiting
Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency
AVP Deficiency, Diabetes Insipidus
Recruiting
Copeptin Measurement After Mannitol and Hypertonic Saline for the Diagnosis of Polyuria-polydipsia Syndrome
Arginine Vasopressin Deficiency, Primary Polydipsia
RecruitingPhase 2
Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus
Central Diabetes Insipidus (cDI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mirjam Christ-Crain, Prof. MD principal investigator
Universitätsspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin nasal spray in people with Arginine Vasopressin Deficiency and Central Diabetes Insipidus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mirjam Christ-Crain, Prof. MD (+41 61 328 70 80, mirjam.christ-crain@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arizona Sexual Experience Scale (ASEX) (Part A) (time frame: before treatment and after the 7 day treatement period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.