NCT05059626 Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee
| NCT ID | NCT05059626 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Penn State University |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 28 participants in total. It began in 2023-12-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05059626 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05059626 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05059626 currently recruiting?
Yes, NCT05059626 is actively recruiting participants. Contact the research team at lma191@psu.edu for enrollment information.
Where is the NCT05059626 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT05059626 clinical trial?
NCT05059626 is sponsored by Penn State University. The trial plans to enroll 28 participants.