EndometriosisEarly Phase 1NCT03746535
Cardiovascular Disease Risk in Women With Endometriosis
A Early Phase 1 study testing Elagolix in people with Endometriosis, run by Yale University at 1 site in United States.
Trial summary
To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Elagolix
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 27 May 2025
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young women between the ages of 18 and 45 years (Controls);
- Young women between the ages of 18 and 45 years with endometriosis.
Who cannot join
- Subjects who smoke
- Subjects who have diabetes,
- Subjects with sleep apnea or BP>140/90 will be excluded.
- Women with endometriosis and severe acute pain requiring immediate treatment will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06519
About this study
Official title: Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis
To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.
Read the detailed description
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.
- Conditions
- Endometriosis
- Being tested
- Elagolix
- Keywords
- endometriosis, elagolix, ntradermal microdialysis, GnRH antagonist, flow mediated vasodilation
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElagolixDrug
Elagolix, 400 mg/day oral, 2X200 mg tablets/day for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Elagolix |
| 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. Receives: Drug: Elagolix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Vasodilation
Blood flow velocity measured using the Sonoscope S2 ultrasound imaging system. Percent change is measured pre and post cuff inflation at baseline and during intervention
Measured: Baseline and during intervention (1 month)
Microdialysis Perfusions of Acetylcholine ED50
Skin blood responses to perfusion of acetylcholine at baseline and during intervention
Measured: Baseline and during intervention (1 month)
Microdialysis Perfusions of Acetylcholine Hill Slope
hill slope of skin blood flow dose perfusions of acetylcholine into skin
Measured: baseline and during intervention (1 month)
Microdialysis Perfusions of Estradiol ED50
Skin blood responses to perfusion of estradiol at baseline and during intervention
Measured: Baseline and during intervention (1 month)
Microdialysis Perfusions of Estradiol- Hill Slope
hill slope of skin blood flow dose perfusions of estradiol into skin
Measured: Baseline and during intervention (1 month)
Secondary outcomes (3)
Plasma Estrogen Concentration
blood draw, this is done on baseline and during intervention
Measured: Baseline and during intervention (1 month)
Serum Concentration Progesterone
Serum concentration progesterone at baseline and during intervention
Measured: Baseline and During intervention (1 month)
Serum Sex Hormone Binding Globulin Concentration
Serum concentration of sex hormone binding globulin concentration taken a baseline and during intervention
Measured: Baseline and During intervention (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start1 Jul 2022
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 cohort clinical trial
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nina Stachenfeld, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746535
- Sponsor's protocol ID
- 2000022193
- Other IDs
- 1R01HL161000-01
- Status last verified
- Sep 2026
- First submitted
- 17 Oct 2018
- Last updated
- 16 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No