Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis

Who is this study for? Women with endometriosis
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Purpose: To determine the effects of SERM and simvastatin interventions on endothelial dysfunction in women with endometriosis. Hypothesis: Treatment with the SERM (bazedoxifene + conjugated estrogen) or with simvastatin will decrease systemic inflammation and improve specific measures of cardiovascular function including endothelium-dependent vasodilation.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Women between the ages of 18 and 45 years with endometriosis (diagnosis by prior laparoscopy by subject's own physician \<10 years prior, and reported by the subject to the researchers)

• Tylenol if the subject has acute pain is allowed

• IUD contraceptive use (copper or levonogestrel) is allowed

Locations
United States
Connecticut
The John B. Pierce Laboratory
RECRUITING
New Haven
Contact Information
Primary
Lacy M Alexander, PhD
lma191@psu.edu
814-867-1781
Backup
Susan K Slimak, RN
sks31@psu.edu
814-863-8556
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 28
Treatments
Other: Simvastatin
30 days of Simvastatin (10mg/day)
Other: bazedoxifene + conjugated estrogen
30 days of bazedoxifene + conjugated estrogen (0.45mg/20mg/day)
Related Therapeutic Areas
Sponsors
Collaborators: The John B. Pierce Laboratory
Leads: Penn State University

This content was sourced from clinicaltrials.gov