Recruiting
Early Phase 1

Observational Study

Sponsor:

Yale University

Code:

NCT03746535

Conditions

Endometriosis

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Elagolix

Study Details

Brief summary:

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

Conditions

Endometriosis

Study ID

NCT03746535

Start date

Jul 1, 2022

Status verified date

May, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Young women between the ages of 18 and 45 years (Controls);
  • Young women between the ages of 18 and 45 years with endometriosis.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Elagolix

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

Primary outcome measure

  • Flow Mediated Vasodilation Microvascular skin blood flow analysis [ Time Frame: 2 minutes ]
  • Microdialysis perfusions [ Time Frame: 15 minutes ]

Central Contacts and Locations

Central contacts

Nina Stachenfeld, PhD

203-562-9901nina.stachenfeld@yale.edu

Locations

Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Nina Stachenfeld

203-530-8071nina.stachenfeld@yale.edu

More Information

Sponsor

Yale University

Last update posted

May 23, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Yale University on 2025-05-23.