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NCT07281547

PHASE4

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-12

Completion Date

2027-06-11

Last Updated

2026-02-18

Healthy Volunteers

Yes

Conditions

Endometrial Carcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood, urine, and endometrial tissue sample collection

DRUG

Low-Dose Aspirin

Given PO

OTHER

Patient Observation

Undergo observation

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Ultrasound Imaging

Undergo pelvic ultrasound

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)

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States