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Nonsteroidal Anti-inflammatory Drug

Salsalate for Endometriosis (Endo3/SA2 Trial)

Phase < 1
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
Abnormal liver function
History of gastrointestinal bleeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days after treatment

Summary

This trial is being conducted to study the effects of an emerging endometriosis treatment, on cardiovascular function in women with endometriosis.

Who is the study for?
This trial is for healthy women aged 18-45, either on birth control or with regular menstrual cycles, who have been diagnosed with endometriosis by laparoscopy within the last 5 years. It's not for those with abnormal liver function, drug use, skin allergies including latex and salsalate, gastrointestinal bleeding history, diabetes (HbA1C ≥6.5%), high blood pressure (>140/90), pregnancy or breastfeeding.
What is being tested?
The study aims to understand how endometriosis may increase heart disease risk by looking at inflammation and blood vessel health. Women will take either a Salsalate pill or a placebo to see if it affects cardiovascular biomarkers like LDL cholesterol and its role in activating certain receptors linked to heart disease.
What are the potential side effects?
Salsalate can cause side effects such as digestive issues (like upset stomach), ringing in the ears, liver problems, rash or hives. Since it's related to aspirin, people allergic to aspirin might react similarly.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver isn't working properly.
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I have had bleeding in my stomach or intestines.
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I have a skin condition, rash, pigmentation disorder, or known skin allergies.
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I am allergic to latex or certain medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biopsy LOX-1 protein expression
Sera LOX-1 protein expression
brachial artery diameter and blood flow velocity
+1 more
Secondary study objectives
sera cytokine expression analysis
sera reproductive hormone analysis
skin biopsy biochemical analysis

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SalsalateExperimental Treatment1 Intervention
3000 mg/day salsalate (1500 mg twice daily) for 5 days
Group II: PlaceboPlacebo Group1 Intervention
1 capsule contain microcrystalline cellulose filler (twice daily) for 5 days

Find a Location

Who is running the clinical trial?

Penn State UniversityLead Sponsor
368 Previous Clinical Trials
127,539 Total Patients Enrolled
4 Trials studying Endometriosis
244 Patients Enrolled for Endometriosis

Media Library

Salsalate Pill (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05069740 — Phase < 1
Salsalate Pill (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05069740 — Phase < 1
Endometriosis Research Study Groups: Salsalate, Placebo
Endometriosis Clinical Trial 2023: Salsalate Pill Highlights & Side Effects. Trial Name: NCT05069740 — Phase < 1
~7 spots leftby Dec 2025
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