NCT07281547Not yet recruitingPhase 4
Low Dose Aspirin to Lower Inflammation and Prevent Endometrial Cancer in Postmenopausal Women With Non-atrophic Endometrial Changes and Pain
Mechanistic Randomized Controlled Feasibility Trial of Aspirin on Endometrium and Inflammatory Metabolites in Postmenopausal Women With Non-Atrophic Endometrial Changes
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 2 Dec 2025
- Start date
- 12 Feb 2027
- Primary completion date
- 11 Jun 2028
- Lead sponsor
- Mayo Clinic
- Diseases
- Endometrial cancer, Childhood cancers
- NCT number
- NCT07281547
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 20
- From 12 Feb 2027 to the primary completion date, 11 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- REGISTRATION: Patients with previous hysterectomy (removal of the uterus)
- REGISTRATION: Contraindication to use of nonsteroidal anti-inflammatory drugs (NSAIDs) or previous adverse reaction or intolerance to NSAIDs
Other illness
- PRE-REGISTRATION: Malignancy found
- REGISTRATION: Patients from outside the Mayo Clinic Comprehensive Cancer Center (MCCCC) area
- REGISTRATION: History of uterine, cervical, or ovarian cancers or precancers (endometrial hyperplasia, cervical dysplasia, fallopian tube intraepithelial carcinoma)
Other
- PRE-REGISTRATION: Not postmenopausal person born with uterus
- PRE-REGISTRATION: Atrophic endometrium
- PRE-REGISTRATION: No uterus
- REGISTRATION: Atrophic endometrium on endometrial sampling performed clinically
- REGISTRATION: Clinically contraindicated to discontinue use of anticoagulation other than aspirin
Who the study is looking for
- 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
Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.