Actively Recruiting

Phase 4
Age: 18Years - 45Years
FEMALE
NCT05059626

Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

Led by Penn State University · Updated on 2024-11-05

28

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

Sponsors

P

Penn State University

Lead Sponsor

T

The John B. Pierce Laboratory

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 45 years with endometriosis diagnosed by laparoscopy within the past 10 years
  • Use of Tylenol allowed for acute pain
  • Use of intrauterine devices (copper or levonorgestrel) allowed
Not Eligible

You will not qualify if you...

  • Use of nicotine products such as smoking or chewing tobacco
  • Diabetes with HbA1C greater than 6.5%
  • Blood pressure above 140/90 mmHg
  • Use of medications affecting peripheral vascular control (e.g., insulin sensitizers, cardiovascular drugs)
  • Pregnancy
  • Breastfeeding
  • Use of illicit or recreational drugs
  • Abnormal liver function
  • Skin disorders or allergies including rash and pigmentation disorders
  • Diagnosed or suspected metabolic or cardiovascular disease
  • Persistent unexplained high serum transaminases
  • Known allergy to latex or study substances

AI-Screening

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Trial Site Locations

Total: 1 location

1

The John B. Pierce Laboratory

New Haven, Connecticut, United States, 06519

Actively Recruiting

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Research Team

L

Lacy M Alexander, PhD

CONTACT

S

Susan K Slimak, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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