Low Dose Aspirin to Lower Inflammation and Prevent Endometrial Cancer in Postmenopausal Women With Non-atrophic Endometrial Changes and Pain

August 3, 2026 updated by: Mayo Clinic

Mechanistic Randomized Controlled Feasibility Trial of Aspirin on Endometrium and Inflammatory Metabolites in Postmenopausal Women With Non-Atrophic Endometrial Changes

This phase IV trial studies whether low dose aspirin can be used to lower inflammation and prevent endometrial cancer in postmenopausal women with changes in the endometrial tissue that are not related to thinning (non-atrophic endometrial changes) and pain. As people age, there is an accumulation of fats, cell death, and inflammation, which causes a surge of pro-cancer-causing events. It is thought that there are several factors involved in the development of endometrial cancer, but that managing the inflammation may address the root cause. Low dose aspirin is aspirin that contains a lower dose than a standard adult tablet. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. Aspirin belongs to the family of drugs called nonsteroidal anti-inflammatory agents. It is also being studied in cancer prevention. Giving low dose aspirin may be an effective way to lower inflammation and prevent endometrial cancer in postmenopausal women with non-atrophic endometrial changes and pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Caroline Chang
  • Phone Number: 904-953-4637

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
        • Contact:
          • Caroline Chang
          • Phone Number: 904-953-4637
        • Principal Investigator:
          • Christopher C. DeStephano, MD, MPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • PRE-REGISTRATION: Postmenopausal women
  • PRE-REGISTRATION: Transvaginal ultrasound
  • PRE-REGISTRATION: Scheduled endometrial biopsy
  • PRE-REGISTRATION: Provide risk factor survey
  • REGISTRATION: Postmenopausal (defined clinically by no period for over 1 year or postmenopausal follicle-stimulating hormone [FSH], estradiol, or anti-Mullerian hormone [AMH] levels due to natural, medical, or surgical causes)
  • REGISTRATION: Have pain (an indicator of inflammation) and other findings warranting endometrial sampling (postmenopausal bleeding [PMB], incidentally noted thickened endometrium > 4mm on ultrasound, obesity, fibroids)
  • REGISTRATION: Capable of providing informed consent
  • REGISTRATION: Understands English or Spanish language for consent and questionnaires
  • REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance
  • REGISTRATION: Willingness to provide mandatory blood specimens for correlative research
  • REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research
  • REGISTRATION: Willingness to provide mandatory urine sample for correlative research

Exclusion Criteria:

  • PRE-REGISTRATION: Not postmenopausal person born with uterus
  • PRE-REGISTRATION: Atrophic endometrium
  • PRE-REGISTRATION: No uterus
  • PRE-REGISTRATION: Malignancy found
  • REGISTRATION: Patients with previous hysterectomy (removal of the uterus)
  • REGISTRATION: Atrophic endometrium on endometrial sampling performed clinically
  • REGISTRATION: Patients from outside the Mayo Clinic Comprehensive Cancer Center (MCCCC) area
  • REGISTRATION: Clinically contraindicated to discontinue use of anticoagulation other than aspirin
  • REGISTRATION: Contraindication to use of nonsteroidal anti-inflammatory drugs (NSAIDs) or previous adverse reaction or intolerance to NSAIDs
  • REGISTRATION: History of uterine, cervical, or ovarian cancers or precancers (endometrial hyperplasia, cervical dysplasia, fallopian tube intraepithelial carcinoma)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (low dose aspirin)
Participants receive low dose aspirin PO QD for up to 42 days in the absence of unacceptable toxicity. Additionally, patients undergo pelvic ultrasound and blood, urine, and endometrial tissue sample collection throughout the trial.
Other: Questionnaire Administration
Ancillary studies
Drug: Low-Dose Aspirin
Given PO
Other Names:
  • Baby Aspirin
Procedure: Ultrasound Imaging
Undergo pelvic ultrasound
Other Names:
  • Ultrasound
  • 2-Dimensional Grayscale Ultrasound Imaging
  • 2-Dimensional Ultrasound Imaging
  • 2D-US
  • Ultrasound Test
  • Ultrasound, Medical
  • US
  • Ultrasonography
Procedure: Biospecimen Collection
Undergo blood, urine, and endometrial tissue sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Active Comparator: Arm II (observation)
Participants undergo observation for up to 42 days in the absence of unacceptable toxicity. Additionally, patients undergo pelvic ultrasound and blood, urine, and endometrial tissue sample collection throughout the trial.
Other: Questionnaire Administration
Ancillary studies
Other: Patient Observation
Undergo observation
Other Names:
  • Observation
  • Active Surveillance
  • deferred therapy
  • expectant management
  • Watchful Waiting
Procedure: Ultrasound Imaging
Undergo pelvic ultrasound
Other Names:
  • Ultrasound
  • 2-Dimensional Grayscale Ultrasound Imaging
  • 2-Dimensional Ultrasound Imaging
  • 2D-US
  • Ultrasound Test
  • Ultrasound, Medical
  • US
  • Ultrasonography
Procedure: Biospecimen Collection
Undergo blood, urine, and endometrial tissue sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in prostaglandin E2 (PGE2)
Time Frame: Baseline to 6 weeks
Assessed by repeated tissue sampling of the endometrium and compared between treatment and observation groups. A linear mixed-effects model (LMM) will be used to compare the change in PGE2 levels obtained from paired endometrial sampling between two groups of patients (aspirin versus [vs.] no aspirin). The continuous time that elapses between sampling will be assessed together with the binary patient group (aspirin vs. no aspirin) to investigate the change in continuous PGE2 measurement.
Baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facilitators and Barriers to Participating in a Clinical Trial After Consenting to Clinical Trial
Time Frame: Baseline to 6 weeks
Assessed at baseline (after consent to participate) using a questionnaire developed for this study: Facilitators and Barriers to Participating in a Clinical Trial After Consenting to Clinical Trial. The survey consists of 7 questions evaluating motivation for participating, barriers to participating, and expectations and understanding of study outcomes. Questions can be answered with one of the listed multiple choice options or with an open-ended "other" option. Post-study data collection will be completed via interview using questions similar to the baseline survey. Results will be analyzed and reported descriptively.
Baseline to 6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of biomarkers with endometrial status
Time Frame: Baseline to 42 days
Biomarkers obtained from biospecimen samples will be assessed for correlation with endometrial status in women on low-dose aspirin versus those not taking low-dose aspirin (observational cohort). Biomarker data will be tested in LMMs for significant association with treatment group and change over time.
Baseline to 42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Christopher C. DeStephano, MD, MPH, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 12, 2027

Primary Completion (Estimated)

June 11, 2028

Study Completion (Estimated)

June 11, 2028

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC240602 (Mayo Clinic)
  • 24-006515 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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