Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

Enrolling by invitation · Phase 4

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID

NCT05059626

Run by

Penn State University

People needed

28

Starts

2023-12-01

Expected to finish

2026-12-31

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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