32 Participants Needed

Norethindrone Acetate-Ethinyl Estradiol for Oxytocin Deficiency

FG
Overseen ByFrancesca Galbiati, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Elizabeth Austen Lawson
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

EA

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

I am between 18 and 65 years old with stable hormone therapy for pituitary issues.
I am between 16 and 65 years old and healthy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of oral Estrogen-progestin to assess oxytocin response

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in oxytocin levels and associated psychopathology measures

48 hours
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Norethindrone Acetate-Ethinyl Estradiol
Trial Overview The study tests how patients with arginine-vasopressin deficiency respond to a single dose of oral Estrogen-progestin compared to healthy controls, and examines the link between oxytocin levels, psychopathology symptoms like anxiety and depression, and quality of life.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Healthy controlExperimental Treatment1 Intervention
Norethindrone Acetate-Ethinyl Estradiol will be given to the healthy controls.
Group II: Arginine-vasopressin deficiencyExperimental Treatment1 Intervention
Norethindrone Acetate-Ethinyl Estradiol will be given to participants with arginine-vasopressin deficiency

Find a Clinic Near You

Who Is Running the Clinical Trial?

Elizabeth Austen Lawson

Lead Sponsor

Trials
4
Recruited
200+

Published Research Related to This Trial

Ethinyl estradiol (EE) and norethindrone acetate (NA), commonly used in oral contraceptives, have low acute and chronic toxicity, indicating they are generally safe for use in humans.
While some studies showed an increased incidence of specific tumors in certain animal models, long-term exposure to EE and NA formulations poses very little health risk to humans, and these agents are not teratogenic when used in combination.
Pharmacology and toxicology of ethinyl estradiol and norethindrone acetate in experimental animals.Maier, WE., Herman, JR.[2018]
In a large study of 59,701 women over 342,348 menstrual cycles, the oral contraceptive norgestimate/ethinyl estradiol demonstrated a very low use-efficacy Pearl index of 0.25 pregnancies per 100 woman-years, indicating high effectiveness in preventing pregnancy.
The contraceptive was well-tolerated, with minimal side effects and significant reductions in bleeding intensity for 32% of women, while only 1% experienced amenorrhea and low rates of spotting (4%) and breakthrough bleeding (3%).
The efficacy and tolerability of norgestimate/ethinyl estradiol (250 micrograms of norgestimate/35 micrograms of ethinyl estradiol): results of an open, multicenter study of 59,701 women.Runnebaum, B., Grunwald, K., Rabe, T.[2022]
In a multicenter study involving patients receiving continuous transdermal estradiol, adding norethindrone acetate at doses of 0.5, 0.75, or 1.0 mg/d for 12 days each month led to significant improvements in symptoms and psychological well-being without major adverse effects.
Skin reactions were mild, with only 10% reporting distinct redness and less than 5% discontinuing treatment due to skin issues, while breakthrough bleeding was infrequent and did not lead to hyperplasia or carcinoma, indicating a safe profile for the combination therapy.
The optimal dose of oral norethindrone acetate for addition to transdermal estradiol: a multicenter study.Fraser, DI., Parsons, A., Whitehead, MI., et al.[2019]

Citations

Pharmacology and toxicology of ethinyl estradiol and norethindrone acetate in experimental animals. [2018]
The efficacy and tolerability of norgestimate/ethinyl estradiol (250 micrograms of norgestimate/35 micrograms of ethinyl estradiol): results of an open, multicenter study of 59,701 women. [2022]
The optimal dose of oral norethindrone acetate for addition to transdermal estradiol: a multicenter study. [2019]
Oral contraceptives. [2017]
Norgestimate: a clinical overview of a new progestin. [2019]
Safety and efficacy of a new oral contraceptive containing drospirenone. [2013]
Radioimmunoassay of norethindrone (17 alpha-ethynyl-17 beta-hydroxy-4-estren-3-one) and ethynyl-estradiol (17 alpha-ethynyl-1,3,5, (10)-estratien-3, 17 beta-diol). Application to human plasma determination of norethindrone after oral administration of this steroid. [2013]
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