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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days after treatment
Awards & highlights

Endo3/SA2 Trial 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.Check my eligibility
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.See study design
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.

Endo3/SA2 Trial 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

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

Endo3/SA2 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
355 Previous Clinical Trials
125,733 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

Frequently Asked Questions

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

Are there any open opportunities to participate in this research?

"Affirmative. The pertinent information found on clinicaltrials.gov indicates that this study, which was initialled shared to the public on January 1st 2022, is currently seeking participants. A total of 40 patients need to be enrolled from 2 separate medical facilities."

Answered by AI

Are participants over 80 years of age excluded from this research endeavor?

"Eligibility to participate in this trial is restricted patients between 18 and 45 years of age. For younger or older participants, there are respectively 4 and 16 other studies available."

Answered by AI

Could you enumerate the investigative endeavors with regards to Salsalate Pill?

"Currently, there is 1 Phase 3 trial and 4 other studies researching Salsalate Pill. The majority of these investigations are conducted in Ann Arbor, Michigan whilst 10 different sites partake in studying this drug."

Answered by AI

What is the highest capacity of patients that can be included in this research experiment?

"Affirmative. According to clinicaltrials.gov, this medical investigation is currently in the recruitment phase. It was first published on January 1st 2022 and recently revised on April 8th 2022; 40 subjects are necessary from 2 different sites for participation."

Answered by AI

Is there an option for me to participate in this experiment?

"This clinical trial is in pursuit of 40 volunteers aged 18-45 who have been diagnosed with endometrioma. As a stipulation, participants are allowed to use Tylenol for the management of acute pain."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Endometriosis and Microvascular Dysfunction: Role of Inflammation
Lacy Alexander 2022. "Endometriosis and Microvascular Dysfunction: Role of Inflammation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05069740.
All > Endometriosis
~10 spots leftby Dec 2025
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