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Selective Estrogen Receptor Modulator

Simvastatin + Duavee for Endometriosis(Endo2/SA3 Trial)

Phase 4
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tylenol if the subject has acute pain is allowed
Be between 18 and 65 years old
Must not have
Be younger than 18 years old
Be older than 65 years old
Screening 3 weeks
Treatment Varies
Follow Upbefore intervention and 30 days post-intervention
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Endo2/SA3 Trial Summary

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

Endo2/SA3 Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You can take Tylenol if you have temporary pain.

Endo2/SA3 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in peripheral blood flow
Change in skin blood flow
Secondary outcome measures
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.

Endo2/SA3 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
348 Previous Clinical Trials
125,130 Total Patients Enrolled
4 Trials studying Endometriosis
244 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with 10mg daily doses of simvastatin?

"Based on its Phase 4 trial status, simvastatin 10mg is deemed to have a safety rating of 3."

Answered by AI

Who are the eligible participants for this clinical trial?

"This research trial is open to 28 individuals aged 18-45 years old suffering from endometrioma. To be considered, applicants must adhere to the following conditions: taking Tylenol for acute pain is acceptable."

Answered by AI

How many participants are currently involved in this research?

"Affirmative. According to the clinicaltrials.gov database, this medical experiment is actively recruiting patients; it was first posted on January 1st 2022 and has since been revised November 8th of the same year. 28 participants are required from a single site for successful completion of the study."

Answered by AI

Is the eligibility criteria for this research study limited to individuals under 35 years of age?

"The requirements to qualify for this clinical trial are that applicants lie between the ages of eighteen and forty-five. For those under 18, there are nine trials available while seventy exist for individuals over 65 years old."

Answered by AI

What is the purpose of this experiment?

"This trial, to be evaluated in a before-and-after timeframe of 30 days, aims at assessing alterations in peripheral blood flow. Additionally, secondary goals include measuring changes in reproductive hormones concentrations, inflammation cytokine concentration and LOX-1 receptor expression."

Answered by AI

Is there currently an opportunity for patients to participate in this experiment?

"This clinical trial, which first went live on the 1st of January 2022, is currently enrolling patients. According to its latest update from 8th November 2022 it can be found on clinicaltrials.gov."

Answered by AI

What is typically the purpose of dosing with simvastatin 10mg?

"Simvastatin 10mg is often recommended for treating hypercholesterolemia. It has been proven to be effective in managing advanced androgen dependent prostate cancer, amenorrhea, and hypoestrogenism as well."

Answered by AI
~19 spots leftby Dec 2025