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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL161000-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.
Our scientific premise is that in women with endometriosis, elevated cardiovascular disease risk is the result of endothelial dysfunction and chronic systemic inflammation through lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) receptor activation. This cardiovascular disease risk is exacerbated by standard estrogen suppression treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients without endometriosis | Active Comparator | Control subjects will be healthy women, with regular menses every 26-34 days. Subjects will be excluded if they have any symptoms of endometriosis, including severe dysmenorrhea or progressive cyclic pelvic pain or prior surgery showing evidence of endometriosis |
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| patients with endometriosis | Experimental | Endometriosis will be diagnosed by history of the disease seen at the time of prior surgery or will be diagnosed by classic clinical symptoms of the disease (cyclic progressive pelvic pain) using prior surgical report reviewed by Dr. Taylor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elagolix | Drug | Elagolix, 400 mg/day oral, 2X200 mg tablets/day for 4 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated Vasodilation Microvascular skin blood flow analysis | Blood flow velocity will be measured using the Sonoscope S2 ultrasound imaging system. | 2 minutes |
| Microdialysis perfusions | Following recovery from the microdialysis probe insertions we will measure resting skin blood flow (SkBF). | 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nina Stachenfeld, PhD | Contact | 203-562-9901 | 219 | nina.stachenfeld@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nina Stachenfeld, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | Recruiting | New Haven | Connecticut | 06519 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2026 |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C539351 | elagolix |
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2 cohort clinical trial
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no masking, all subjects have endometriosis
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| D000091662 | Genital Diseases |