Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women

PHASE2CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

January 1, 2017

Primary Completion Date

February 1, 2023

Study Completion Date

February 1, 2023

Conditions
Estrogen DeficiencyCardiovascular Disease (CVD)Functional Hypothalamic AmenorrheaEndothelial 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.

Trial Locations (1)

90048

Cedars-Sinai Barbra Streisand Women's Heart Center, Los Angeles

All Listed Sponsors
lead

Cedars-Sinai Medical Center

OTHER

NCT03018366 - Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women | Biotech Hunter | Biotech Hunter