Arginine Vasopressin DeficiencyEarly Phase 1Pedi-EVOLVENCT07568509
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
A Early Phase 1 study testing Norethindrone Acetate-Ethinyl Estradiol in people with Arginine Vasopressin Deficiency and Oxytocin Deficiency, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
An open-labeled, interventional pilot trial, 10 youth with AVP-D and 10 PD matched for age, sex, and BMI will be recruited from Pediatric Endocrinology and Neuroendocrinology at Massachusetts General Hospital and in the community. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Arginine Vasopressin Deficiency, Oxytocin Deficiency, Pediatric Disease
- What is being tested?
- Norethindrone Acetate-Ethinyl Estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2026to Apr 2027
- Phase
- Early Phase 1
- 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 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- AVP-D diagnosis
- Age 7 to 21 years
- Stable pituitary hormone replacement (no change in dose of hormone replacement in 4 weeks prior to baseline)
- If on estrogen/progestin, participants agree to stop for at least 6 weeks prior to Main study visits
- English language proficiency
- Pituitary disease diagnosis
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- Age 7 to 21 years
- Eligible participants are not required to be on hormone replacement for pituitary deficiencies. If receiving pituitary hormone replacement, no change in dose in 4 weeks prior to baseline)
- If on estrogen/progestin, participants agree to stop for at least 6 weeks prior to Main study visits
- English language proficiency
Who cannot join
- Current AVP-D diagnosis or desmopressin use
- History of pulmonary embolism or unprovoked deep venous thrombosis
- History of breast/endometrial cancer as well as current therapies on estrogen modulators/blockers (i.e., tamoxifen, raloxifene, aromatase inhibitors)
- History of ischemic stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral arterial disease
- Pregnancy or breastfeeding within the last 8 weeks
- History of stage 3 chronic kidney disease or cirrhosis
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- Active tobacco smoking or nicotine use
- Psychosis or active suicidality
- Known genetic cause of vasopressin deficiency.
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Hannah Lamont, PhD, 617-726-1347, MGHHypopit@MGH.HARVARD.EDU
About this study
Official title: Identifying a Provocation Test for Diagnosis of Oxytocin Deficiency in Youth With Hypopituitarism
An open-labeled, interventional pilot trial, 10 youth with AVP-D and 10 PD matched for age, sex, and BMI will be recruited from Pediatric Endocrinology and Neuroendocrinology at Massachusetts General Hospital and in the community. This study tests the hypothesis that oral estrogen/progestin will stimulate endogenous oxytocin release in control subjects. Eligible participants will receive two tablets in a single administration containing a total of 1 mg of norethindrone acetate 70 mcg of ethinyl estradiol. Sampling for blood and saliva will take place at baseline and approximately 24 hours following study drug administration. Neuropsychological assessment (anxiety, mood and emotion regulation; impulse control; aberrant eating behaviors; social cognition and functioning; quality of life) will be assessed at baseline to characterize the study population.
- Being tested
- Norethindrone Acetate-Ethinyl Estradiol
- Medical subject headings
- Diabetes Insipidus, Neurogenic, Hypopituitarism
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
Norethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with hypopituitary disease with Arginine-vasopressin deficiency (AVP-D). | Experimental | Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency. Receives: Drug: Norethindrone Acetate-Ethinyl Estradiol |
| Individuals with hypopituitary disease (without AVP-D) | Experimental | Norethindrone Acetate-Ethinyl Estradiol will be given to control subjects. 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 neurophysin-1 from baseline
Change in neurophysin-1 levels from baseline to 24 hours
Measured: 0 minutes (Baseline) and 24 hours
Secondary outcomes (1)
Change in oxytocin from baseline
Change in oxytocin from baseline to 24 hours
Measured: 0 minutes (Baseline) and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start17 Aug 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (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 Massachusetts General HospitalThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Austen Lawson, Massachusetts General Hospital
- Investigators
- Elizabeth A Lawson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568509
- Sponsor's protocol ID
- 2025P001958
- Acronym
- Pedi-EVOLVE
- Status last verified
- Aug 2026
- First submitted
- 28 Apr 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying a Provocation Test for Diagnosis of Oxytocin Deficiency in Youth With Hypopituitarism
- ClinicalTrials.gov ID
- NCT07568509
- Acronym / sponsor ID
- Pedi-EVOLVE / 2025P001958
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 May 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.
An open-labeled, interventional pilot trial, 10 youth with AVP-D and 10 PD matched for age, sex, and BMI will be recruited from Pediatric Endocrinology and Neuroendocrinology at Massachusetts General Hospital and in the community. This study tests the hypothesis that oral estrogen/progestin will stimulate endogenous oxytocin release in control subjects. Eligible participants will receive two tablets in a single administration containing a total of 1 mg of norethindrone acetate 70 mcg of ethinyl estradiol. Sampling for blood and saliva will take place at baseline and approximately 24 hours following study drug administration. Neuropsychological assessment (anxiety, mood and emotion regulation; impulse control; aberrant eating behaviors; social cognition and functioning; quality of life) will be assessed at baseline to characterize the study population.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with hypopituitary disease with Arginine-vasopressin deficiency (AVP-D). | Experimental | Drug: Norethindrone Acetate-Ethinyl EstradiolNorethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency. |
| Individuals with hypopituitary disease (without AVP-D) | Experimental | Drug: Norethindrone Acetate-Ethinyl EstradiolNorethindrone Acetate-Ethinyl Estradiol will be given to control subjects. |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- AVP-D diagnosis
- Age 7 to 21 years
- Stable pituitary hormone replacement (no change in dose of hormone replacement in 4 weeks prior to baseline)
- If on estrogen/progestin, participants agree to stop for at least 6 weeks prior to Main study visits
- English language proficiency
Key exclusion criteria (10 listed)
- Current AVP-D diagnosis or desmopressin use
- History of pulmonary embolism or unprovoked deep venous thrombosis
- History of breast/endometrial cancer as well as current therapies on estrogen modulators/blockers (i.e., tamoxifen, raloxifene, aromatase inhibitors)
- History of ischemic stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral arterial disease
- Pregnancy or breastfeeding within the last 8 weeks
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-progestinNorethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort. | Drug | Individuals with hypopituitary disease (without AVP-D), Individuals with hypopituitary disease with Arginine-vasopressin deficiency (AVP-D). |
Primary outcome
Change in neurophysin-1 from baseline
Time frame: 0 minutes (Baseline) and 24 hours
Change in neurophysin-1 levels from baseline to 24 hours
1 secondary outcome
Change in oxytocin from baseline
Time frame: 0 minutes (Baseline) and 24 hours
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 26 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Arginine Vasopressin Deficiency
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Copeptin Measurement After Mannitol and Hypertonic Saline for the Diagnosis of Polyuria-polydipsia Syndrome
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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.
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 Massachusetts General Hospital 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 10 inclusion and 10 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 26 Oct 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?
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 Hannah Lamont, PhD (617-726-1347, MGHHypopit@MGH.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neurophysin-1 from baseline (time frame: 0 minutes (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 26 Oct 2026.