RECRUITING

Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

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Conditions

EndometriosisSkin blood flowEstrogenSelective Estrogen Receptor ModulatorIntradermal Microdialysis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05059626

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Tylenol if the subject has acute pain is allowed
  3. * IUD contraceptive use (copper or levonogestrel) is allowed
  1. * Use of nicotine-containing products (e.g. smoking, chewing tobacco, etc.)
  2. * Diabetes (HbA1C .6.5%)
  3. * BP\>140/90
  4. * Taking pharmacotherapy that could alter peripheral vascular control (e.g. insulin sensitizing, cardiovascular medications)
  5. * Pregnancy
  6. * Breastfeeding
  7. * Taking illicit and/or recreational drugs
  8. * Abnormal liver function
  9. * Rash, skin disease, disorders of pigmentation, known skin allergies
  10. * Diagnosed or suspected metabolic or cardiovascular disease
  11. * Persistent unexplained elevations of serum transaminases
  12. * Known allergy to latex or investigative substances

Contacts and Locations

Study Contact

Lacy M Alexander, PhD
CONTACT
814-867-1781
lma191@psu.edu
Susan K Slimak, RN
CONTACT
814-863-8556
sks31@psu.edu

Study Locations (Sites)

The John B. Pierce Laboratory
New Haven, Connecticut, 06519
United States

Collaborators and Investigators

Sponsor: Penn State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-12-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Skin blood flow
  • Estrogen
  • Selective Estrogen Receptor Modulator
  • Intradermal Microdialysis

Additional Relevant MeSH Terms

  • Endometriosis