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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT07281547
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood, urine, and endometrial tissue sample collection
  • Low-Dose Aspirin — DRUG
    Given PO
  • Patient Observation — OTHER
    Undergo observation
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Ultrasound Imaging — PROCEDURE
    Undergo pelvic ultrasound

Study Details

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.

Key Dates

Start date
Aug 12, 2026
Status verified
Feb 2026
Primary completion
Jun 11, 2027
Completion
Jun 11, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in prostaglandin E2 (PGE2) [ Time Frame: Baseline to 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
Caroline Chang
904-953-4637
Christopher C. DeStephano, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Mayo Clinic in Florida· Jacksonville, FL

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