Aspirin for reduction of breast density and inflammatio

Phase 1

• Conditions: Healthy volunteers; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2017-000317-22-SE
• Lead Sponsor: inköping University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-17
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

•Postmenopausal women defined as > 12 months since last menstruation
•55-74 years of age
•A baseline left breast density score of > 75% as measured by standard digital
mammography (BIRADs score D)
•A willingness to follow the study protocol, as indicated by provision of informed consent to participate
•A willingness to avoid taking NSAIDs outside of the trial (rare NSAID use for musculoskeletal symptoms excepted)
•Healthy without serious co-morbidity, according to the investigators decision
•Normal renal function as determined by a serum creatinine < upper limit of normal

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•Abnormal finding on MRI at screening
•Any sex steroid containing systemic hormonal therapy including postmenopausal replacement therapy and hormonal IUD (intrauterine device) ongoing or within the last 3 months
•Previously affected or treated breasts including irradiation and reductive surgery. Diagnostic and investigative punctures are allowed.
•Current or anticipated need for daily NSAID use including ASA for cardiovascular protection
•Known intolerance to NSAIDs
•History of cardiovascular disease including prior myocardial infarction, angina, stroke, or transient ischemic attack (TIA)
•Known contraindication to NSAID use
•History of breast cancer including in situ disease
•Diabetes requiring drug therapy
•Current smoker
•Uncontrolled hypertension
•History of GI ulcers, chronic GERD (reflux disease), or GI bleeding in the past 5 years
•History of a bleeding diathesis or current anticoagulant therapy
•History of claustrophobia
•MR contraindications according to the radiologist’s decision
•Allergy to gadolinium contrast

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified