Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women
Public ClinicalTrials.gov record NCT03018366. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03018366
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 29 participants
Conditions and interventions
Conditions
Interventions
- 17beta Estradiol Drug
- Transdermal placebo patch Drug
- Progesterone Drug
- Placebo Pill Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2016
- Primary completion
- Jan 31, 2023
- Completion
- Jan 31, 2023
- Last update posted
- Mar 12, 2025
2017 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Barbra Streisand Women's Heart Center | Los Angeles | California | 90048 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03018366, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 12, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03018366 live on ClinicalTrials.gov.