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Selective Estrogen Receptor Modulator

Simvastatin + Duavee for Endometriosis (Endo2/SA3 Trial)

Phase 4
Recruiting
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Diabetes (HbA1C .6.5%)
Taking pharmacotherapy that could alter peripheral vascular control (e.g. insulin sensitizing, cardiovascular medications)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before intervention and 30 days post-intervention
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing whether two different treatments can improve heart function in women with endometriosis by reducing inflammation.

Who is the study for?
This trial is for women aged 18-45 with a prior diagnosis of endometriosis confirmed by laparoscopy within the last 5 years. Participants must not use nicotine, have diabetes, high blood pressure, abnormal liver function, cardiovascular disease, skin conditions or allergies relevant to the study drugs, and cannot be pregnant or breastfeeding.
What is being tested?
The trial is testing whether simvastatin (10mg) and SERM (bazedoxifene + conjugated estrogens) can reduce inflammation and improve cardiovascular function in women with endometriosis. The focus is on how these treatments affect endothelium-dependent vasodilation—a marker of vascular health.
What are the potential side effects?
Potential side effects may include muscle pain or weakness from simvastatin and hormonal changes such as hot flashes or leg cramps from bazedoxifene/estrogen therapy. Liver function might also be affected due to medication metabolism.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My diabetes is confirmed with an HbA1C over 6.5%.
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I am on medication that affects blood flow or heart health.
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My liver isn't working properly.
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I have a skin condition, rash, pigmentation disorder, or known skin allergies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before intervention and 30 days post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and before intervention and 30 days post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in peripheral blood flow
Change in skin blood flow
Secondary study objectives
Change in LOX-1 activity
Change in inflammation
Body Weight Changes
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: bazedoxifene + conjugated estrogenExperimental Treatment1 Intervention
30 days of bazedoxifene + conjugated estrogen (0.45mg/20mg/day)
Group II: SimvastatinExperimental Treatment1 Intervention
30 days of Simvastatin (10mg/day)

Find a Location

Who is running the clinical trial?

Penn State UniversityLead Sponsor
370 Previous Clinical Trials
127,977 Total Patients Enrolled
4 Trials studying Endometriosis
240 Patients Enrolled for Endometriosis
The John B. Pierce LaboratoryOTHER
2 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

Bazedoxifene/Estrogens,Conjugated (Selective Estrogen Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05059626 — Phase 4
Endometriosis Research Study Groups: bazedoxifene + conjugated estrogen, Simvastatin
Endometriosis Clinical Trial 2023: Bazedoxifene/Estrogens,Conjugated Highlights & Side Effects. Trial Name: NCT05059626 — Phase 4
Bazedoxifene/Estrogens,Conjugated (Selective Estrogen Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05059626 — Phase 4
~14 spots leftby Dec 2025
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