CompletedPhase 2

Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women

United States29 participantsStarted 2017-01-01

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, 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, exclu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of Change of Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry

Timeframe: Baseline, week 12 on trial

Trial details

NCT IDNCT03018366

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-01

Results submitted2024-12-20

View on ClinicalTrials.gov More Estrogen Deficiency trials