Overview

Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women

Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to determine whether low estrogen levels in young women with hypothalamic amenorrhea (premenopausal HypoE) is associated with risk factors for cardiovascular disease. For this study, the investigators will measuring vascular function and immune markers on: - young women with 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 will then be randomized to use either an estrogen patch or a placebo patch (no active medicine) for 3 months, 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 immune function.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Cedars-Sinai Medical Center
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Estrogens
Polyestradiol phosphate
Progesterone
Criteria
Inclusion Criteria:

For premenopausal Hypo E and normal control women inclusions include:

- Premenopausal currently not on hormone therapy,

- English speaking (for the purposes of complete psychosocial assessment)

- able to give informed consent

- a gynecological age (age since menarche) > 10 and < 25 years, and chronological age >
18 years

- Within 90-110% of ideal body weight as determined by the 1983 Metropolitan height and
weight table for women

- All participants with hypothalamic amenorrhea will be diagnosed based on exclusion of
other etiologies for their amenorrhea, including pregnancy, thyroid dysfunction,
hyperprolactinemia, premature ovarian insufficiency, and polycystic ovary disease

For recently menopausal women inclusions include:

- Follicle stimulating hormones (FSH) >30 and 12 months of amenorrhea,92 within 3 years
of final menstrual period with natural menopausal not on hormone therapy

- English speaking

- Able to give informed consent

- Within 90-110% of ideal body weight

Exclusion Criteria:

For premenopausal Hypo E and normal control women exclusions include:

- Smoking

- Hypertension

- Hyperlipidemia

- Diabetes

- Medications including psychotropic or illicit drugs, medical, neurological

- Ophthalmologic disease except acuity problems

- Major Axis I disorder other than depression

- Pregnancy in the last 12 months and/or lactating in the last 6 months

- Current use of hormone contraceptive or any estrogen or progestin therapy

For HypoE women, exclusion criteria include:

- Allergy to adhesive or tape

For recently menopausal women exclusions also include:

- Previous or current use of hormone therapy, estrogen or progestin

- Surgical or chemotherapy induced menopause

- Premature ovarian failure