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NCT07281547

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

Not Yet Recruiting
PHASE4All AgesInterventionalPrevention
Mayo Clinic
~20 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Biospecimen CollectionLow-Dose AspirinPatient ObservationQuestionnaire AdministrationUltrasound Imaging

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in prostaglandin E2 (PGE2)
Measured over Baseline to 6 weeks

Conditions

Endometrial Carcinoma

Explore related trials

Endometrial Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Christopher C. DeStephano, MD, MPH · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Change in prostaglandin E2 (PGE2)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.