Actively Recruiting
External Mastalgia-oil Versus Placebo in Premenopausal Women With Severe Mastalgia
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-02-02
190
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, double-blind, randomized clinical trial to explore the efficacy and safety of external mastalgia-oil versus placebo in premenopausal women with severe mastalgia.
CONDITIONS
Official Title
External Mastalgia-oil Versus Placebo in Premenopausal Women With Severe Mastalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premenopausal females aged 18 years or older
- Regular menstrual cycles (28 ± 5 days) with severe mastalgia lasting at least 6 consecutive cycles, with a pain score of 4 or higher for at least 7 days
- Breast ultrasound showing BI-RADS classification 1-3; if mammography is done, also BI-RADS 1-3
- Willingness to complete follow-up visits, tests, and questionnaires independently or with help
- Willingness to use effective contraception before, during, and for three months after the study; negative pregnancy test if of childbearing potential
- Laboratory results within specified safe limits for blood counts, liver and kidney function tests
You will not qualify if you...
- Suspected breast diseases other than breast pain or benign cysts, or other malignant tumors
- Use of hormonal medications, sex hormone modulators, B vitamins, essential oils, NSAIDs, or strong pain relievers in the past 3 months; tamoxifen use in the past 6 months
- History of breast surgery, malignancy, or thromboembolism within the last 5 years
- Smokers or those with systemic or skin sensitivity to essential oils or placebo
- Serious diseases of heart, liver, kidneys, blood system, or mental illness
- Breast skin damage that destroys the outer skin layer (e.g., eczema, ulcers)
- Serious or uncontrolled infections including active hepatitis, HIV, syphilis, or lung infections
- Pregnant, breastfeeding, or planning pregnancy; recent unprotected sex; implanted breasts
- More than 25% decrease in breast pain during placebo lead-in cycle, excluding further treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, China
Actively Recruiting
Research Team
C
Chang Gong, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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