Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women

What this trial studies

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.

Conditions in scope

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

Interventions

• 17beta Estradiol (Drug) — 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…
• Transdermal placebo patch (Drug) — 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.
• Progesterone (Drug) — 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…
• Placebo Pill (Drug) — After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.

Who can join

Women only · Ages 18 Years to 60 Years · Accepts healthy volunteers.

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:

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE2
• Start date: 2017-01-01
• Primary completion: 2023-02-01
• Last update posted: 2025-03-13
• First posted: 2017-01-12

Sponsor & contact

Lead sponsor: Cedars-Sinai Medical Center (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Rate of Change of Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (Baseline, week 12 on trial)
  Change in PAT measured as reactive hyperemia index (RHI) from baseline to week 12 on treatment or placebo. Reactive hyperemia index (RHI) is the post-to-pre occlusion PAT signal ratio in the occluded arm, relative to the same ratio in the control arm, corrected for baseline vascular tone of the occluded arm calculated by taking the ratio of the pulse amplitude…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.