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NCT Number: NCT07281547

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

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.

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Key information

Conditions

Endometrial Carcinoma Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location contact

Caroline Chang

CONTACT

904-953-4637

Christopher C. DeStephano, MD, MPH

PRINCIPAL_INVESTIGATOR

Clinical Trials Referral Office

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood, urine, and endometrial tissue sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Low-dose aspirin

Drug

Given PO

Other names: Baby Aspirin

Patient Observation

Other

Undergo observation

Other names: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting

Questionnaire Administration

Other

Ancillary studies

Ultrasound Imaging

Procedure

Undergo pelvic ultrasound

Other names: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, Ultrasound, Ultrasound Test, Ultrasound, Medical, US

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Chang

CONTACT

904-953-4637

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 15, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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