Norethindrone Acetate-Ethinyl Estradiol for Oxytocin Deficiency

(Pedi-EVOLVE Trial)

Overseen By Hannah Lamont, PhD

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Massachusetts General Hospital

Must not be taking: Estrogen modulators/blockers

Disqualifiers: Pulmonary embolism, Breast cancer, Stroke, Pregnancy, Tobacco use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Elizabeth A Lawson, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

I have AVP-D, stable hormone doses, and can speak English.

I have hypopituitary disease and my hormone doses have not changed in the last 6 weeks.

Exclusion Criteria

I do not have recent serious illnesses, cancer history, or risky medication or lifestyle factors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single administration of norethindrone acetate and ethinyl estradiol, with blood and saliva sampling at baseline and 24 hours post-administration

1 day

2 visits (in-person)

Follow-up

Participants are monitored for changes in neurophysin-1 and oxytocin levels, as well as neuropsychological assessments

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Norethindrone Acetate-Ethinyl Estradiol

How Is the Trial Designed?

Group I: Individuals with hypopituitary disease with Arginine-vasopressin deficiency (AVP-D). Experimental Treatment 1 Intervention

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

Group II: Individuals with hypopituitary disease (without AVP-D) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+