Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Penn State University
• Collaborator: The John B. Pierce Laboratory
• Treatments: Bazedoxifene; Estrogens; Simvastatin

Criteria

Inclusion Criteria:

• Women between the ages of 18 and 45 years with endometriosis (diagnosis by prior laparoscopy by subject's own physician <5 years prior, and reported by the subject to the researchers)

• Tylenol if the subject has acute pain is allowed

• Contraceptive use is allowed

Exclusion Criteria:

• 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