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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arginine-vasopressin deficiency | Experimental | Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency |
|
| Healthy control | Experimental | Norethindrone Acetate-Ethinyl Estradiol will be given to the healthy controls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norethindrone Acetate-Ethinyl Estradiol | Drug | Estrogen-progestin will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and healthy control cohort. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peripheral oxytocin concentration from 0 to 24 hours | Change in peripheral oxytocin concentration from 0 to 24 hours | Time points: time 0 min (baseline) and 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Adults 18-65 years old Arginine-vasopressin deficiency Stable pituitary hormone replacement
Exclusion Criteria for all participants:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Lawson, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D020790 | Diabetes Insipidus, Neurogenic |
| 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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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
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|
| From time 0 min (baseline) to 48 hours |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |