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Nonacetylated Salicylate

Salsalate for Polycystic Ovary Syndrome (TIN-PCOS-AOD Trial)

Phase 2

Recruiting

Led By Frank González, M.D.

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-40 years of age

Willingness to use double-barrier contraception such as condoms and topical spermicide or non-hormonal intrauterine device (IUD), or permanent sterilization of the subject or her partner

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from pre-treatment baseline after 12 weeks of salsalate administration

Awards & highlights

TIN-PCOS-AOD Trial Summary

This trial is testing whether salsalate, a nonacetylated salicylate, can reduce ovarian androgen secretion and inflammation in women with PCOS, independent of excess adiposity or IR status.

Who is the study for?

Women aged 18-40 with PCOS, who are in good health and not on medication affecting hormone or carbohydrate metabolism. They must use reliable contraception if sexually active and have a diagnosis of PCOS confirmed by specific criteria including hyperandrogenism and menstrual irregularities.Check my eligibility

What is being tested?

The trial is testing the effect of salsalate, an anti-inflammatory drug, on ovarian function and inflammation in women with PCOS. It's a randomized study comparing salsalate to placebo over 12 weeks to see if it reduces ovarian androgen production and inflammation.See study design

What are the potential side effects?

Salsalate may cause side effects similar to other salicylates such as stomach pain, heartburn, nausea, vomiting, ringing in the ears or allergic reactions. Since it affects inflammation pathways, there might be changes in blood sugar levels or interactions with other medications.

TIN-PCOS-AOD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 40 years old.

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I agree to use effective birth control methods during the study.

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I have PCOS, shown by high male hormones, irregular periods, and bleeding after a progestin test.

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I am between 18 and 40 years old.

TIN-PCOS-AOD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from pre-treatment baseline after 12 weeks of salsalate administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from pre-treatment baseline after 12 weeks of salsalate administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre-treatment baseline after 12 weeks of salsalate administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aim 1: Area under the curve (AUC) for circulating testosterone from serial measurements during HCG stimulation test

Aim 2: Maximum lipid-stimulated mononuclear cell nuclear factor ĸB activation during cream challenge test

Secondary outcome measures

Aim1: Fractional glucose disappearance / insulin concentration unit during insulin-modified frequently-sampled intravenous tolerance test adjusted for hepatic and peripheral insulin clearance

TIN-PCOS-AOD Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Salsalate-Treated Obese PCOSExperimental Treatment1 Intervention

n=15

Group II: Salsalate-Treated Lean PCOS without IRExperimental Treatment1 Intervention

n=15

Group III: Salsalate-Treated Lean PCOS with IRExperimental Treatment1 Intervention

n=15

Group IV: Placebo-Treated Lean PCOS without IRPlacebo Group1 Intervention

n=15

Group V: Placebo-Treated Lean PCOS with IRPlacebo Group1 Intervention

n=15

Group VI: Placebo-Treated Obese PCOSPlacebo Group1 Intervention

n=15

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Salsalate

2007

Completed Phase 4

~1650

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

609 Previous Clinical Trials

1,559,219 Total Patients Enrolled

2 Trials studying Polycystic Ovary Syndrome

327 Patients Enrolled for Polycystic Ovary Syndrome

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,405 Total Patients Enrolled

6 Trials studying Polycystic Ovary Syndrome

621 Patients Enrolled for Polycystic Ovary Syndrome

Frank González, M.D.Principal InvestigatorUniversity of Illinois at Chicago

2 Previous Clinical Trials

72 Total Patients Enrolled

1 Trials studying Polycystic Ovary Syndrome

47 Patients Enrolled for Polycystic Ovary Syndrome

Media Library

Salsalate (Nonacetylated Salicylate) Clinical Trial Eligibility Overview. Trial Name: NCT03229408 — Phase 2

Polycystic Ovary Syndrome Research Study Groups: Salsalate-Treated Lean PCOS without IR, Placebo-Treated Lean PCOS without IR, Salsalate-Treated Lean PCOS with IR, Placebo-Treated Lean PCOS with IR, Salsalate-Treated Obese PCOS, Placebo-Treated Obese PCOS

Polycystic Ovary Syndrome Clinical Trial 2023: Salsalate Highlights & Side Effects. Trial Name: NCT03229408 — Phase 2

Salsalate (Nonacetylated Salicylate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03229408 — Phase 2

Frequently Asked Questions

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

Would octogenarians be eligible to participate in this research?

"People aged 18 to 40 who wish to enroll in this clinical trial are eligible to do so. In contrast, there are 423 trials for people under 18 and 1302 trials for patients over the age of 65."

Answered by AI

How many people are the investigators hoping to enroll in this research project?

"The listing on clinicaltrials.gov verifies that this study is still recruiting patients. This particular trial was first posted on December 5th, 2018 and was last updated on May 18th, 2020. They are currently seeking 90 individuals to participate at a single location."

Answered by AI

What other investigations have included Salsalate as a variable?

"Currently, there are five ongoing studies investigating salsalate. One of these studies has progressed to phase 3 clinical trials. The majority of research locations for salsalate are in Ann Arbor, Michigan; however, there are a total of 10 sites running active trials."

Answered by AI