Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women

Summary

The purpose of this study is to determine whether young women with functional hypothalamic amenorrhea (premenopausal HypoE) is associated with risk factors for pre-clinical cardiovascular disease (CVD).

For this study, the investigators will measuring vascular function and inflammatory markers on:

* young women with functional hypothalamic amenorrhea (\>3 months of no menstrual cycle due to low estrogen)
* young women with regular menstrual cycles not on hormone therapy.
* recently menopausal women (\<3 years from final menstrual period) not on hormone therapy.

Premenopausal HypoE participants (women with functional hypothalamic amenorrhea) will be randomized to use either an estrogen patch or a placebo patch (no active medicine) for 12 weeks, followed by estrogen or placebo patch plus progesterone or placebo pills for 2 additional weeks. The investigators are looking to see if estrogen improves vascular and inflammation.

Conditions

• Estrogen Deficiency
• Cardiovascular Disease (CVD)
• Functional Hypothalamic Amenorrhea
• Endothelial Dysfunction

Interventions

DRUG

17beta Estradiol

Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides.

DRUG

Transdermal placebo patch

Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.

DRUG

Progesterone

After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.

DRUG

Placebo Pill

After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.

Sponsors & Collaborators

• Cedars-Sinai Medical Center

  lead OTHER

Principal Investigators

• Chrisandra Shufelt, MD · Cedars-Sinai Medical Center

• Noel Bairey-Merz, MD · Cedars-Sinai Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-01-01

Primary Completion

2023-02-01

Completion

2023-02-01

FDA Drug

Yes

Countries

• United States

Study Locations