RecruitingPhase 4NCT05059626

Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

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


Sponsor

Penn State University

Enrollment

28 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

  • 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

Exclusion Criteria12

  • Use of nicotine-containing products (e.g. smoking, chewing tobacco, etc.)
  • Diabetes (HbA1C .6.5%)
  • BP>140/90
  • Taking pharmacotherapy that could alter peripheral vascular control (e.g. insulin sensitizing, cardiovascular medications)
  • Pregnancy
  • Breastfeeding
  • Taking illicit and/or recreational drugs
  • Abnormal liver function
  • Rash, skin disease, disorders of pigmentation, known skin allergies
  • Diagnosed or suspected metabolic or cardiovascular disease
  • Persistent unexplained elevations of serum transaminases
  • Known allergy to latex or investigative substances

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Interventions

DRUGsimvastatin 10mg

Simvastation acts as a systemic LOX inhibitor.

DRUGBazedoxifene 20/Estrogens,Con 0.45Mg Tb

Duavee is a selective estrogen receptor modulator.


Locations(1)

The John B. Pierce Laboratory

New Haven, Connecticut, United States

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NCT05059626


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