Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee
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 includ
| Condition(s) | Endometriosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * 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 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 d |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Lead sponsor | Penn State University |
| Locations | New Haven, Connecticut, United States |
| Start date | 2023-12-01 |
| NCT ID | NCT05059626 |
| Official listing | https://clinicaltrials.gov/study/NCT05059626 |