At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women
In Brief
A Phase 2 clinical trial evaluating 17beta Estradiol, Transdermal placebo patch, and 2 other interventions for Estrogen Deficiency and 3 related conditions. Completed, enrolled 29 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
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.
After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.