Effects of Simvastatin and Duavee on Endometriosis and Heart Health
Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis
This study is testing if the medications simvastatin and Duavee can help improve heart health and reduce inflammation in women with endometriosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Penn State University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05059626 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of simvastatin and a selective estrogen receptor modulator (SERM) on endothelial dysfunction in women diagnosed with endometriosis. The research aims to determine whether these interventions can reduce systemic inflammation and improve cardiovascular function, particularly endothelium-dependent vasodilation. By focusing on the relationship between endometriosis and cardiovascular disease risk, the study seeks to address a significant gap in understanding how to manage these co-morbidities effectively.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 45 with a confirmed diagnosis of endometriosis.
Not a fit: Patients with pre-existing cardiovascular disease, diabetes, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health and reduced inflammation for women suffering from endometriosis.
How similar studies have performed: While there is limited research specifically targeting this combination of treatments for endometriosis, studies have shown promising results in addressing cardiovascular risks associated with inflammatory conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 disease * Persistent unexplained elevations of serum transaminases * Known allergy to latex or investigative substances
Where this trial is running
New Haven, Connecticut
- The John B. Pierce Laboratory — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Study coordinator: Lacy M Alexander, PhD
- Email: lma191@psu.edu
- Phone: 814-867-1781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.