AVP DeficiencyPHOENIXNCT07361263
Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency
A study testing estradiol valerate and esthinylestradiol in people with AVP Deficiency and Diabetes Insipidus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The PHOENIX study aims to investigate whether oral estradiol valerate (EV) and ethinylestradiol (EE) can stimulate oxytocin (OXT) and neurophysin-1 (NP-1) release in humans. The goal is to assess their potential as a safe diagnostic stimulation test for oxytocin deficiency, particularly in patients with arginine… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- AVP Deficiency, Diabetes Insipidus
- What is being tested?
- estradiol valerate and esthinylestradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Jan 2026to Feb 2027
- Phase
- Interventional
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part 1
- Adult healthy controls
- No medication (including hormonal contraception)
- Female patients (except post-menopausal): regular cycle (21-35 days of duration) in the last 6 months
- Part 2
- Confirmed diagnosis of AVP-Deficiency
- Age ≥ 18 years
- Female patients (except post-menopausal): regular cycle (21-35 days of duration) in the last 6 months or in the case of hormone replacement therapy, with a 1-week pause from the respective treatment
Who cannot join
- Part 1
- Participation in a trial with investigational drugs within 30 days
- BMI >30
- Age >50
- Illicit substance use (except for cannabis) during the last 30 days
- Consumption of alcoholic beverages >15 drinks/week
Show all 26Show fewer
- Tobacco smoking >10 cigarettes/day
- Pregnancy and breastfeeding
- Hormonal contraception
- Migraine with and without aura
- Any cardiometabolic, cardiovascular, and hematological diseases (including deep vein thrombosis/pulmonary embolism and thrombophilia (DVT/PE))
- Active liver dysfunction or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
- Diagnosed chronic kidney disease (CKD) > grade III (GRF < 30ml/min)
- Part 2
- Participation in a trial with investigational drugs within 30 days
- BMI >30
- Age >50
- Illicit substance use (except for cannabis) during the last 30 days
- Consumption of alcoholic beverages >15 drinks/week
- Tobacco smoking >10 cigarettes/day
- Pregnancy and breastfeeding
- Hormonal contraception
- Migraine with and without aura
- Any cardiometabolic, cardiovascular, and hematological diseases (including DVT/PE and Thrombophilia)
- Active liver dysfunction or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
- Diagnosed CKD > grade III (GRF < 30ml/min)
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
Andi Nikaj, MD, +41 61 328 57 43, andi.nikaj@usb.ch
Michelle Müller, MD, +41 61 328 55 23, michelle.mueller@usb.ch
About this study
Official title: Plasma Oxytocin in Response to Oral Estradiol Valerate and Ethinylestradiol in Healthy Controls and Patients With AVP-Deficiency
The PHOENIX study aims to investigate whether oral estradiol valerate (EV) and ethinylestradiol (EE) can stimulate oxytocin (OXT) and neurophysin-1 (NP-1) release in humans. The goal is to assess their potential as a safe diagnostic stimulation test for oxytocin deficiency, particularly in patients with arginine vasopressin (AVP) deficiency.
Read the detailed description
Oxytocin (OXT) and arginine vasopressin (AVP) are hypothalamic peptides involved in water balance and emotional regulation. Patients with AVP-Deficiency (central diabetes insipidus) often experience psychological symptoms such as anxiety and depressed mood, possibly due to coexisting OXT deficiency. Previous research showed that 3,4-Methylenedioxy-N-methylamphetamine (MDMA) can increase plasma OXT in healthy individuals but not in AVP-deficient patients, suggesting a clinically relevant OXT deficiency. However, the side effects of MDMA limit its clinical use as a diagnostic tool. Estrogen is known to stimulate OXT release via estrogen receptor β in the hypothalamus. This study evaluates whether oral estradiol valerate (EV) and ethinylestradiol (EE) can safely and effectively provoke OXT and NP-1 release, offering a potential alternative to MDMA-based tests.
The study consists of two parts:
Part 1 (Proof of Concept): A randomized, double-blind, cross-over trial in healthy adults to compare the stimulatory effects of EV and EE on plasma OXT and NP-1.
Part 2 (Pilot Study): An open-label trial in patients with AVP-Deficiency using the estrogen compound identified as most effective in Part 1, to determine whether OXT and NP-1 responses are blunted compared to healthy controls.
- Conditions
- AVP Deficiency, Diabetes Insipidus
- Being tested
- estradiol valerate, esthinylestradiol
- Keywords
- Oxytocin, estradiol valerate, ethinylestradiol
- Medical subject headings
- Diabetes Insipidus, Neurogenic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiol valerateDrug
estradiol valerate
esthinylestradiolDrug
estradiol valerate
| Study group | Role | What they receive |
|---|---|---|
| Study Part I | Experimental | Healthy Participants will be randomized to receive either first oral Estradiol Valerate or oral Ethinylestradiol. After a washout-phase of at least 7 days or one menstrual cycle for female participants, the second visit of the study will be conducted. Healthy participants will be blinded to the order. Receives: Drug: estradiol valerate; Drug: esthinylestradiol |
| Study Part II | Experimental | Participants will receive only one estrogen formulation. Patients with AVP-Deficiency will be aware of the intervention. Receives: Drug: estradiol valerate; Drug: esthinylestradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change in Plasma Oxytocin
The primary endpoint is the relative change in plasma oxytocin (OXT) concentrations (pg/mL respectively pM) from baseline to the maximum observed value within 300 minutes after administration of oral estradiol valerate (EV) or ethinylestradiol (EE). Baseline is defined as 100% of the initial pre-dose concentration.
Measured: From baseline (0 min) to 300 minutes post-dose.
Relative Change in Neurophysin-1
The primary endpoint is the relative change in neurophysin-1 (NP-1) concentrations (pg/mL respectively pM) from baseline to the maximum observed value within 300 minutes after administration of oral estradiol valerate (EV) or ethinylestradiol (EE). Baseline is defined as 100% of the initial pre-dose concentration.
Measured: From baseline (0 min) to 300 minutes post-dose.
Secondary outcomes (26)
Area Under the Curve (AUC) for Plasma OXT and NP-1
Measured: From baseline (0 min) to 300 minutes post-dose.
Peak change in plasma OXT/NP-1 levels
Measured: From baseline (0 min) to 300 minutes post-dose.
Time course of plasma OXT/NP-1 levels
Measured: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: time course (von Willebrand factor)
Time course and peak of coagulation marker von Willebrand factor
Measured: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: time course (Protein S)
Time course and peak of coagulation marker Protein S
Measured: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: time course (D-dimer)
Time course and peak of coagulation marker D-dimer
Measured: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: time course (Factor VIII)
Time course and peak of coagulation marker Factor VIII
Measured: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: time course (Fibrinogen)
Time course and peak of coagulation marker Fibrinogen
Measured: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: peak (von Willebrand factor)
Peak of coagulation marker von Willebrand factor
Measured: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: peak (Protein S)
Peak of coagulation marker Protein S
Measured: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: peak (D-dimer)
Peak of coagulation marker D-dimer
Measured: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: peak (Factor VIII)
Peak of coagulation marker Factor VIII
Measured: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: peak (Fibrinogen)
Peak of coagulation marker Fibrinogen
Measured: From baseline (0 min) to 300 minutes post-dose.
Changes in Other Endocrine Hormones
Time course of plasma estrogen, testosterone, copeptin, cortisol,Luteinizing Hormone/Follicle-Stimulating Hormone (LH/FSH), and other pituitary hormones.
Measured: From baseline (0 min) to 300 minutes post-dose.
Subjective Emotional Effects
Changes in subjective feelings assessed by Numeric Rating Scale (NRS). NRS will be repeatedly used to assess subjective alterations in consciousness over time. NRS will be presented as a range from 0 to 10 marked with "not at all" on the left and "extremely" on the right. The following NRS will be used: "any effect", "good effect", "bad effect", "liking", "high", "happy", "fear", "stimulated", "feeling close to others", "concentration", "thinking", "open", and "trust".
Measured: At baseline (0 min), 30, 60, 90, 120, 150, 180, 210, 240, 270 and 300 minutes and 24 hours post-dose.
Adverse effects
Participants will be asked to report any adverse events that occur during the sessions or between sessions at the start of the next session. The test requires about 2 minutes.
Measured: 300 minutes post-dose.
List of complaints (LC)
The LC consists of 66 items, yielding a global score measuring physical and general discomfort. The LC list is administered at the beginning and the end of the session with reference to complaints throughout the entire session.
Measured: 300 minutes post-dose.
Changes in anxiety assessed by State-Trait Anxiety Inventory (STAI-State and Trait).
This is a questionnaire given to adults to determine the general anxiety levels. Based on responses to 20 items, with scores ranging from 1 ("almost never") to 4 ("almost always"), a total score is calculated. The total trait score (STAI-T) ranges from 20 to 80, with higher scores indicating more pronounced anxiety and scores. The STAI-T evaluates relatively stable aspects of "anxiety proneness," including general states of calmness, confidence, and security. A score above 45/80 indicating clinically significant anxiety symptoms. The state score (STAI-S) evaluates the current state of anxiety, asking how respondents feel "right now," using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. We will use the STAI-T for the baseline visit and the STAI-S for the treatment visits. The test requires about 5 minutes.
Measured: Baseline, 90 and 270 minutes post-dose.
Emotion Recognition Performance - EmBody/EmFace Task
The EmBody and EmFace subtasks comprise each of 42 stimuli showing body or facial expressions of angry, happy, or neutral affect (14 clips per emotion, half in front view and half in half-profile side view from the left). Stimuli last 1.5 seconds at 24 frames per second and are geometrically and optically standardized to prevent biases induced by ethnic cues (e.g., hair or skin tone) or clothing. Item order is pseudorandom to prevent sequence effects and was determined using the following constraints: the same emotion is shown no more than twice in a row; the same view per emotion is not shown consecutively (i.e., no angry-front, angry-front). The test is performed twice during each treatment visit.
Measured: Baseline and 270 minutes post-dose.
Emotion Recognition Performance - Face Recognition Task (FERT)
The FERT is used to assess recognition of basic emotions. The task includes 10 neutral faces and 160 faces that express one of four basic emotions (i.e., happiness, sadness, anger, and fear), with pictures morphed between 0% (neutral) and 100% in 10% steps. Two female and two male pictures are used for each of the four emotions. Stimuli are shown in random order for 500 ms and are then replaced by the rating screen where participants have to indicate the correct emotion. The outcome measure is accuracy (proportion correct). The test data is recorded on a computer and processed into scores for each emotion using an established matlab routine according to standard operating procedures (SOP) (clinical pharmacology, Orca DKF). The test is performed once during each treatment visit, exactly 270min after EV/EE administration.
Measured: At 270 minutes post-dose.
Vital parameters: blood pressure
Blood pressure (systolic and diastolic) will be measured at several timepoints during the treatment visit
Measured: 30 minutes pre-dose; 0, 30, 60, 120, 150, 180, 210, 240, 270, 300minutes, 24hours post-dose.
Vital parameters: heart rate
Heart rate will be measured at several timepoints during the treatment visit
Measured: 30 minutes pre-dose; 0, 30, 60, 120, 150, 180, 210, 240, 270, 300minutes, 24hours post-dose.
Vital parameters: body temperature
body temperature will be measured at several timepoints during the treatment visit
Measured: 30 minutes pre-dose; 0, 30, 60, 120, 150, 180, 210, 240, 270, 300minutes, 24hours post-dose.
Concentration of Plasma Sodium
Sodium concentration (mmol/l) will be assessed in plasma.
Measured: At 0, 180 and 300 minutes post-dose.
Concentration of Plasma Potassium
Sodium concentration (mmol/l) will be assessed in plasma.
Measured: At 0, 180 and 300 minutes post-dose.
Concentration of Saliva Oxytocin
Measured: At 0, 60, 90, 120, 180, 270, 300 minutes and 24 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start9 Jan 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AVP 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will be conducted in two parts. Part 1 is a double-blinded, randomized cross-over proof-of-concept trial in healthy adults. Part 2 is an open-labeled single arm pilot study in adults with an established diagnosis of AVP-Deficiency. Study parts 1 and 2 will be conducted consecutively. For part 1 16 participants will be enrolled and for part 2 12 patients will be enrolled.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 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. Dr., Study chair, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361263
- Sponsor's protocol ID
- 2025-02197;kt25ChristCrain5
- Other IDs
- 2025
- Acronym
- PHOENIX
- Status last verified
- Aug 2026
- First submitted
- 5 Jan 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Oxytocin in Response to Oral Estradiol Valerate and Ethinylestradiol in Healthy Controls and Patients With AVP-Deficiency
- ClinicalTrials.gov ID
- NCT07361263
- Acronym / sponsor ID
- PHOENIX / 2025-02197;kt25ChristCrain5
- Conditions
- AVP Deficiency, Diabetes Insipidus
- Keywords
- Oxytocin, estradiol valerate, ethinylestradiol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Jan 2026 (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 PHOENIX study aims to investigate whether oral estradiol valerate (EV) and ethinylestradiol (EE) can stimulate oxytocin (OXT) and neurophysin-1 (NP-1) release in humans. The goal is to assess their potential as a safe diagnostic stimulation test for oxytocin deficiency, particularly in patients with arginine vasopressin (AVP) deficiency.
Detailed description
Oxytocin (OXT) and arginine vasopressin (AVP) are hypothalamic peptides involved in water balance and emotional regulation. Patients with AVP-Deficiency (central diabetes insipidus) often experience psychological symptoms such as anxiety and depressed mood, possibly due to coexisting OXT deficiency. Previous research showed that 3,4-Methylenedioxy-N-methylamphetamine (MDMA) can increase plasma OXT in healthy individuals but not in AVP-deficient patients, suggesting a clinically relevant OXT deficiency. However, the side effects of MDMA limit its clinical use as a diagnostic tool. Estrogen is known to stimulate OXT release via estrogen receptor β in the hypothalamus. This study evaluates whether oral estradiol valerate (EV) and ethinylestradiol (EE) can safely and effectively provoke OXT and NP-1 release, offering a potential alternative to MDMA-based tests.
The study consists of two parts:
Part 1 (Proof of Concept): A randomized, double-blind, cross-over trial in healthy adults to compare the stimulatory effects of EV and EE on plasma OXT and NP-1.
Part 2 (Pilot Study): An open-label trial in patients with AVP-Deficiency using the estrogen compound identified as most effective in Part 1, to determine whether OXT and NP-1 responses are blunted compared to healthy controls.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study will be conducted in two parts. Part 1 is a double-blinded, randomized cross-over proof-of-concept trial in healthy adults. Part 2 is an open-labeled single arm pilot study in adults with an established diagnosis of AVP-Deficiency. Study parts 1 and 2 will be conducted consecutively. For part 1 16 participants will be enrolled and for part 2 12 patients will be enrolled.
| Arm | Type | Receives |
|---|---|---|
| Study Part I | Experimental | Drug: estradiol valerate, Drug: esthinylestradiolHealthy Participants will be randomized to receive either first oral Estradiol Valerate or oral Ethinylestradiol. After a washout-phase of at least 7 days or one menstrual cycle for female participants, the second visit of the study will be conducted. Healthy participants will be blinded to the order. |
| Study Part II | Experimental | Drug: estradiol valerate, Drug: esthinylestradiolParticipants will receive only one estrogen formulation. Patients with AVP-Deficiency will be aware of the intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Part 1
- Adult healthy controls
- No medication (including hormonal contraception)
- Female patients (except post-menopausal): regular cycle (21-35 days of duration) in the last 6 months
- Part 2
Key exclusion criteria (26 listed)
- Part 1
- Participation in a trial with investigational drugs within 30 days
- BMI >30
- Age >50
- Illicit substance use (except for cannabis) during the last 30 days
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 |
|---|---|---|
| estradiol valerateestradiol valerate | Drug | Study Part I, Study Part II |
| esthinylestradiolestradiol valerate | Drug | Study Part I, Study Part II |
Primary outcome
Relative Change in Plasma Oxytocin
Time frame: From baseline (0 min) to 300 minutes post-dose.
The primary endpoint is the relative change in plasma oxytocin (OXT) concentrations (pg/mL respectively pM) from baseline to the maximum observed value within 300 minutes after administration of oral estradiol valerate (EV) or ethinylestradiol (EE). Baseline is defined as 100% of the initial pre-dose concentration.
Relative Change in Neurophysin-1
Time frame: From baseline (0 min) to 300 minutes post-dose.
The primary endpoint is the relative change in neurophysin-1 (NP-1) concentrations (pg/mL respectively pM) from baseline to the maximum observed value within 300 minutes after administration of oral estradiol valerate (EV) or ethinylestradiol (EE). Baseline is defined as 100% of the initial pre-dose concentration.
26 secondary outcomes
Area Under the Curve (AUC) for Plasma OXT and NP-1
Time frame: From baseline (0 min) to 300 minutes post-dose.
Peak change in plasma OXT/NP-1 levels
Time frame: From baseline (0 min) to 300 minutes post-dose.
Time course of plasma OXT/NP-1 levels
Time frame: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: time course (von Willebrand factor)
Time frame: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: time course (Protein S)
Time frame: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: time course (D-dimer)
Time frame: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: time course (Factor VIII)
Time frame: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: time course (Fibrinogen)
Time frame: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: peak (von Willebrand factor)
Time frame: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: peak (Protein S)
Time frame: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: peak (D-dimer)
Time frame: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: peak (Factor VIII)
Time frame: From baseline (0 min) to 300 minutes post-dose.
Changes in Coagulation Parameters: peak (Fibrinogen)
Time frame: From baseline (0 min) to 300 minutes post-dose.
Changes in Other Endocrine Hormones
Time frame: From baseline (0 min) to 300 minutes post-dose.
Subjective Emotional Effects
Time frame: At baseline (0 min), 30, 60, 90, 120, 150, 180, 210, 240, 270 and 300 minutes and 24 hours post-dose.
Adverse effects
Time frame: 300 minutes post-dose.
List of complaints (LC)
Time frame: 300 minutes post-dose.
Changes in anxiety assessed by State-Trait Anxiety Inventory (STAI-State and Trait).
Time frame: Baseline, 90 and 270 minutes post-dose.
Emotion Recognition Performance - EmBody/EmFace Task
Time frame: Baseline and 270 minutes post-dose.
Emotion Recognition Performance - Face Recognition Task (FERT)
Time frame: At 270 minutes post-dose.
Vital parameters: blood pressure
Time frame: 30 minutes pre-dose; 0, 30, 60, 120, 150, 180, 210, 240, 270, 300minutes, 24hours post-dose.
Vital parameters: heart rate
Time frame: 30 minutes pre-dose; 0, 30, 60, 120, 150, 180, 210, 240, 270, 300minutes, 24hours post-dose.
Vital parameters: body temperature
Time frame: 30 minutes pre-dose; 0, 30, 60, 120, 150, 180, 210, 240, 270, 300minutes, 24hours post-dose.
Concentration of Plasma Sodium
Time frame: At 0, 180 and 300 minutes post-dose.
Concentration of Plasma Potassium
Time frame: At 0, 180 and 300 minutes post-dose.
Concentration of Saliva Oxytocin
Time frame: At 0, 60, 90, 120, 180, 270, 300 minutes and 24 hours post-dose.
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 11 Aug 2026.
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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. Dr. study chair
University Hospital of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing estradiol valerate and esthinylestradiol in people with AVP Deficiency and 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 8 inclusion and 26 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 11 Aug 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Andi Nikaj, MD (+41 61 328 57 43, andi.nikaj@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Change in Plasma Oxytocin (time frame: From baseline (0 min) to 300 minutes post-dose.). 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 11 Aug 2026.