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NCT03018366 · ClinicalTrials.gov registry record · Phase 2
Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women
A Phase 2 study of Endothelial Dysfunction and Estrogen Deficiency, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT03018366: Completed Phase 2 study of Endothelial Dysfunction and Estrogen Deficiency, sponsored by Cedars-Sinai Medical Center.
NCT03018366 is a Phase 2 study of Endothelial Dysfunction and Estrogen Deficiency that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 29 participants, below the 92-participant average among 45 other Endothelial Dysfunction trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03018366, a Phase 2 study of Endothelial Dysfunction and Estrogen Deficiency, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 during the hyperemic phase (after a period of blood flow occlusion) to the baseline pulse amplitude. The values below \<1.67 are abnormal
Conditions Studied
Interventions
- DRUG Progesterone
- DRUG Placebo Pill
- DRUG Transdermal placebo patch
- DRUG 17beta Estradiol
Study Locations (1)
California
- Cedars-Sinai Barbra Streisand Women's Heart Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2017-01-01 |
| Est. Completion | 2023-02-01 |
| Phase | Phase 2 |
What the finished NCT03018366 record still lists
NCT03018366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 92-participant average among 45 other Endothelial Dysfunction trials with a reported enrollment target (68% lower).
The record links to 4 conditions, with Endothelial Dysfunction appearing as the primary indexed condition, and to 4 interventions - of which Progesterone is the first listed.
NCT03018366 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03018366 about?
NCT03018366 is a clinical study titled "Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women". 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: ...
What is the current status of trial NCT03018366?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2017-01-01. Estimated completion is 2023-02-01.
What conditions does trial NCT03018366 study?
This clinical trial studies the following conditions: Endothelial Dysfunction, Estrogen Deficiency, Cardiovascular Disease (CVD), Functional Hypothalamic Amenorrhea.
What interventions are being tested in trial NCT03018366?
The interventions under investigation include: Progesterone (DRUG), Placebo Pill (DRUG), Transdermal placebo patch (DRUG), 17beta Estradiol (DRUG).
Who is sponsoring clinical trial NCT03018366?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03018366 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03018366's enrollment target sits among peer trials
29 34th of 45 higher than 12 of 45 other Endothelial Dysfunction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endothelial Dysfunction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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