NCT05059626Enrolling by invitationPhase 4
Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee
Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 10 Sept 2021
- Start date
- 1 Dec 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Penn State University
- Diseases
- Endometriosis
- NCT number
- NCT05059626
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 28
- From 1 Dec 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking pharmacotherapy that could alter peripheral vascular control (e.g. insulin sensitizing, cardiovascular medications)
- Taking illicit and/or recreational drugs
Other illness
- Rash, skin disease, disorders of pigmentation, known skin allergies
- Diagnosed or suspected metabolic or cardiovascular disease
- Known allergy to latex or investigative substances
Lab values
- Diabetes (HbA1C .6.5%)
- Persistent unexplained elevations of serum transaminases
Other
- Use of nicotine-containing products (e.g. smoking, chewing tobacco, etc.)
- BP\>140/90
- Pregnancy
- Breastfeeding
- Abnormal liver function
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The John B. Pierce Laboratory Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.