Norethindrone Acetate-Ethinyl Estradiol for Oxytocin Deficiency
What You Need to Know Before You Apply
What is the purpose of this trial?
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:1. Salivary and blood oxytocin response to Estrogen-progestin will be lower in arginine-vasopressin deficiency compared to healthy control.2. Lower salivary and blood oxytocin levels will be associated with more severe symptoms of anxiety, depression, and social emotional difficulties as well as lower quality of life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is Norethindrone Acetate-Ethinyl Estradiol generally safe for humans?
Norethindrone Acetate and Ethinyl Estradiol, commonly used in oral contraceptives, have been shown to have low toxicity in both short-term and long-term use. While some studies in animals showed an increased risk of tumors, this was not observed in monkeys, and these hormones are not known to cause birth defects when used together. Overall, they pose very little health risk to humans.12345
How does the drug Norethindrone Acetate-Ethinyl Estradiol differ from other treatments for oxytocin deficiency?
Norethindrone Acetate-Ethinyl Estradiol is unique because it combines two synthetic hormones commonly used in oral contraceptives, which are now being explored for other therapeutic uses. This combination has been shown to have low toxicity and minimal health risks with long-term use, making it a novel approach for conditions like oxytocin deficiency where standard treatments may not exist.12567
Who Is on the Research Team?
Elizabeth A Lawson, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with arginine-vasopressin deficiency who are on stable pituitary hormone replacement therapy. It also includes a control group of healthy adults within the same age range.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of oral Estrogen-progestin to assess oxytocin response
Follow-up
Participants are monitored for changes in oxytocin levels and associated psychopathology measures
What Are the Treatments Tested in This Trial?
Interventions
- Norethindrone Acetate-Ethinyl Estradiol
Find a Clinic Near You
Who Is Running the Clinical Trial?
Elizabeth Austen Lawson
Lead Sponsor