Cardiovascular Disease Risk in Women With Endometriosis

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT03746535
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Elagolix — DRUG
    Elagolix, 400 mg/day oral, 2X200 mg tablets/day for 4 days.

Study Details

To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.

Key Dates

Start date
Jul 1, 2022
Status verified
May 2025
Primary completion
Dec 1, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: patients without endometriosis
    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
  • Experimental: patients with endometriosis
    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.

Primary Outcome Measure

Flow Mediated Vasodilation Microvascular skin blood flow analysis [ Time Frame: 2 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06519
Nina Stachenfeld
[email protected]
203-530-8071

Find similar trials in New Haven, CT

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Yale School of Medicine· New Haven, CT

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