Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 7 Years and 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

(participants with AVP-D): AVP-D diagnosed in clinic using standard of care diagnostic tools; Stable pituitary hormone replacement (no change in dose of hormone replacement in six weeks prior to baseline); If on estrogen/progestin, female participants agree to stop for at least 6 weeks prior to Main study visits; English language proficiency. Inclusion criteria (participants with hypopituitary disease): Hypopituitary disease diagnosis; If receiving pituitary hormone replacement, no change in dose in six 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.

Exclusion Criteria

(all participants): 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 stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral arterial disease; Pregnancy or breastfeeding within the last 8 weeks; Medication changes within 2 weeks of enrollment or within 5 half-lives of the respective medication; History of stage 3 chronic kidney disease or cirrhosis; Any significant illness or condition that the investigator determines could interfere with study participation, data collection or safety.; Active tobacco smoking or nicotine patch use; Psychosis or active suicidality.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Individuals with hypopituitary disease with Arginine-vasopressin deficiency (AVP-D).
Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency.
  • Drug: Norethindrone Acetate-Ethinyl Estradiol
    Norethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort.
    Other names:
    • Estrogen-progestin
Experimental
Individuals with hypopituitary disease (without AVP-D)
Norethindrone Acetate-Ethinyl Estradiol will be given to control subjects.
  • Drug: Norethindrone Acetate-Ethinyl Estradiol
    Norethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort.
    Other names:
    • Estrogen-progestin

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Hannah Lamont, PhD
617-726-1347
MGHHypopit@MGH.HARVARD.EDU

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Hannah Lamont, PhD
617-726-1347
MGHHypopit@MGH.HARVARD.EDU

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.