Recruiting
Early Phase 1

Estrogen/Progestin

Sponsor:

Massachusetts General Hospital

Code:

NCT07568509

Conditions

Arginine Vasopressin Deficiency

Oxytocin Deficiency

Pediatric Disease

Hypopituitarism

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

Interventions

Norethindrone Acetate-Ethinyl Estradiol

Study Details

Brief 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. 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

Arginine Vasopressin Deficiency

Oxytocin Deficiency

Pediatric Disease

Hypopituitarism

Study ID

NCT07568509

Start date

Aug 17, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Individuals with hypopituitary disease with Arginine-vasopressin deficiency (AVP-D).

Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency.

experimental: Individuals with hypopituitary disease (without AVP-D)

Norethindrone Acetate-Ethinyl Estradiol will be given to control subjects.

Interventions

Norethindrone Acetate-Ethinyl Estradiol

Norethindrone Acetate-Ethinyl Estradiol will be given to participants in both cohorts, arginine-vasopressin deficiency cohort and control cohort.

Primary outcome measure

  • Change in neurophysin-1 from baseline [ Time Frame: 0 minutes (Baseline) and 24 hours ]

Central Contacts and Locations

Central contacts

Hannah Lamont, PhD

617-726-1347MGHHypopit@MGH.HARVARD.EDU

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Hannah Lamont, PhD

617-726-1347MGHHypopit@MGH.HARVARD.EDU

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-08-21.