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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with hypopituitary disease with Arginine-vasopressin deficiency (AVP-D). | Experimental | Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency. |
|
| Individuals with hypopituitary disease (without AVP-D) | Experimental | Norethindrone Acetate-Ethinyl Estradiol will be given to control subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norethindrone Acetate-Ethinyl Estradiol | Drug | Norethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in neurophysin-1 from baseline | Change in neurophysin-1 levels from baseline to 24 hours | 0 minutes (Baseline) and 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in oxytocin from baseline | Change in oxytocin from baseline to 24 hours | 0 minutes (Baseline) and 24 hours |
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Inclusion criteria (participants with AVP-D):
Inclusion criteria (participants with hypopituitary disease):
Exclusion criteria (all participants):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah Lamont, PhD | Contact | 617-726-1347 | MGHHypopit@MGH.HARVARD.EDU |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Lawson, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D020790 | Diabetes Insipidus, Neurogenic |
| D007018 | Hypopituitarism |
| ID | Term |
|---|---|
| D003919 | Diabetes Insipidus |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C020416 | norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination |
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|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |