Arginine Vasopressin DeficiencyEarly Phase 1NCT06460948
Identifying Oxytocin Deficiency in Adults With Pituitary Disease
A Early Phase 1 study testing Norethindrone Acetate-Ethinyl Estradiol in people with Arginine Vasopressin Deficiency and Oxytocin Deficiency, run by Elizabeth Austen Lawson at 1 site in United States.
Trial summary
This is an open-label, pilot study, to characterize oxytocin response to a single dose of oral Estrogen-progestin in patients with arginine-vasopressin deficiency compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Arginine Vasopressin Deficiency, Oxytocin Deficiency
- What is being tested?
- Norethindrone Acetate-Ethinyl Estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2024to 17 Mar 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AVD Group:
- Adults 18-65 years old Arginine-vasopressin deficiency Stable pituitary hormone replacement
- Healthy Control Group Adults 16-65 years old
Who cannot join
- History of pulmonary embolism, deep vein thrombosis, breast/endometrial cancer, stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral artery disease
- Pregnancy or breastfeeding within last 8 weeks
- Any significant illness or condition that the investigator determines could interfere with study participation, data collection, or safety
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Characterizing Oxytocin Response to Oral Estrogen Administration in Adults With Arginine Vasopressin Deficiency
This is an open-label, pilot study, to characterize oxytocin response to a single dose of oral Estrogen-progestin in patients with arginine-vasopressin deficiency compared to healthy controls. The association between oxytocin levels and measures of psychopathology (i.e., anxiety and depression) and quality of life across groups will be examined. We hypothesize that:
- Salivary and blood oxytocin response to Estrogen-progestin will be lower in arginine-vasopressin deficiency compared to healthy control.
- Lower salivary and blood oxytocin levels will be associated with more severe symptoms of anxiety, depression, and social emotional difficulties as well as lower quality of life.
- Being tested
- Norethindrone Acetate-Ethinyl Estradiol
- 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.
Norethindrone Acetate-Ethinyl EstradiolDrug
Also called Estrogen-progestin
Estrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort.
| Study group | Role | What they receive |
|---|---|---|
| Arginine-vasopressin deficiency | Experimental | Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency Receives: Drug: Norethindrone Acetate-Ethinyl Estradiol |
| Healthy control | Experimental | Norethindrone Acetate-Ethinyl Estradiol will be given to the healthy controls. Receives: Drug: Norethindrone Acetate-Ethinyl Estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peripheral oxytocin concentration from 0 to 24 hours
Change in peripheral oxytocin concentration from 0 to 24 hours
Measured: Time points: time 0 min (baseline) and 24 hours
Secondary outcomes (1)
Area under the curve of salivary oxytocin from baseline to 48 hours following Estrogen-progestin administration in patients with arginine-vasopressin deficiency compared to healthy controls
Difference from baseline to oxytocin peak (blood and saliva) between patients with arginine-vasopressin deficiency compared to healthy controls.
Correlation between oxytocin area under the curve and psychopathology and quality of life measures across groups.
Measured: From time 0 min (baseline) to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start13 Nov 2024
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
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.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study Model description: In this open-labeled, interventional pilot trial, 16 adults with arginine-vasopressin deficiency and 16 healthy controls balanced for age, sex, and body mass index will be recruited
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Austen Lawson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elizabeth Austen Lawson, Massachusetts General Hospital
- Investigators
- Elizabeth A Lawson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460948
- Sponsor's protocol ID
- 2024P001090
- Status last verified
- May 2026
- First submitted
- 11 Jun 2024
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Oxytocin Response to Oral Estrogen Administration in Adults With Arginine Vasopressin Deficiency
- ClinicalTrials.gov ID
- NCT06460948
- Acronym / sponsor ID
- 2024P001090
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Elizabeth Austen LawsonUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 14 Jun 2024 (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.
This is an open-label, pilot study, to characterize oxytocin response to a single dose of oral Estrogen-progestin in patients with arginine-vasopressin deficiency compared to healthy controls. The association between oxytocin levels and measures of psychopathology (i.e., anxiety and depression) and quality of life across groups will be examined. We hypothesize that:
- Salivary and blood oxytocin response to Estrogen-progestin will be lower in arginine-vasopressin deficiency compared to healthy control.
- Lower salivary and blood oxytocin levels will be associated with more severe symptoms of anxiety, depression, and social emotional difficulties as well as lower quality of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study Model description: In this open-labeled, interventional pilot trial, 16 adults with arginine-vasopressin deficiency and 16 healthy controls balanced for age, sex, and body mass index will be recruited
| Arm | Type | Receives |
|---|---|---|
| Arginine-vasopressin deficiency | Experimental | Drug: Norethindrone Acetate-Ethinyl EstradiolNorethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency |
| Healthy control | Experimental | Drug: Norethindrone Acetate-Ethinyl EstradiolNorethindrone Acetate-Ethinyl Estradiol will be given to the healthy controls. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AVD Group:
- Adults 18-65 years old Arginine-vasopressin deficiency Stable pituitary hormone replacement
- Healthy Control Group Adults 16-65 years old
Key exclusion criteria (3 listed)
- History of pulmonary embolism, deep vein thrombosis, breast/endometrial cancer, stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral artery disease
- Pregnancy or breastfeeding within last 8 weeks
- Any significant illness or condition that the investigator determines could interfere with study participation, data collection, or safety
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 |
|---|---|---|
| Norethindrone Acetate-Ethinyl EstradiolAlso: Estrogen-progestinEstrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort. | Drug | Arginine-vasopressin deficiency, Healthy control |
Primary outcome
Change in peripheral oxytocin concentration from 0 to 24 hours
Time frame: Time points: time 0 min (baseline) and 24 hours
Change in peripheral oxytocin concentration from 0 to 24 hours
1 secondary outcome
Area under the curve of salivary oxytocin from baseline to 48 hours following Estrogen-progestin administration in patients with arginine-vasopressin deficiency compared to healthy controls
Time frame: From time 0 min (baseline) to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Elizabeth A Lawson, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Norethindrone Acetate-Ethinyl Estradiol in people with Arginine Vasopressin Deficiency and Oxytocin Deficiency, run by Elizabeth Austen Lawson at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 13 May 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peripheral oxytocin concentration from 0 to 24 hours (time frame: Time points: time 0 min (baseline) and 24 hours). 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 13 May 2026.