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Compares treatment options for Mastalgia
Official title External Mastalgia-oil Versus Placebo in Premenopausal Women With Severe Mastalgia
ClinicalTrials.gov ID: NCT06966245
What this study is testing
What is mastalgia-oil?
mastalgia-oil is an investigational medicine, being studied as a potential treatment for mastalgia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join if
- Premenopausal females aged ≥ 18 years old
- Pre-existing regular menstrual cycle (28 ± 5 days) with mastalgia lasting for at least 6 consecutive menstrual cycles; with severe mastalgia [visual...
- With breast ultrasound: BI-RADS classification 1-3; if mammography is required: also BI-RADS classification 1-3
- Willingness to follow up and complete required tests; ability to complete questionnaires independently or with assistance
- Willingness to use effective contraception (vaginally administered estrogen and hormone-coated IUDs are permitted) prior to study entry, during study...
You likely can't join if
- With suspected breast disease (e.g., mastitis, malignant breast tumor) other than breast pain or benign breast cysts, or with other malignant tumors
- Use of hormonal medications (e.g., oral contraceptives, glucocorticoids, etc.), sex hormone modulators (SERMS, AIs, SERDs, etc.), B vitamins...
- Prior history of breast surgery (including minimally invasive surgery), history of malignancy, or history of thromboembolism within the last 5 years...
- Smokers; essential oils or placebo systemic/skin sensitization
- With serious primary diseases of the heart, liver, kidneys and hematopoietic system, or mental illness, etc.
- Accompanied by skin damage on the breast that destroys the stratum corneum (e.g., eczema, ulcers)
See the full eligibility criteria
- Premenopausal females aged ≥ 18 years old
- Pre-existing regular menstrual cycle (28 ± 5 days) with mastalgia lasting for at least 6 consecutive menstrual cycles; with severe mastalgia [visual analog scale (VAS) score ≥ 4 for at least 7 days] and without chest...
- With breast ultrasound: BI-RADS classification 1-3; if mammography is required: also BI-RADS classification 1-3
- Willingness to follow up and complete required tests; ability to complete questionnaires independently or with assistance
- Willingness to use effective contraception (vaginally administered estrogen and hormone-coated IUDs are permitted) prior to study entry, during study participation, and for three months after discontinuation of the...
- Requisite laboratory values:white blood cell count: ≥ 4.0 × 10\^9/L, absolute neutrophil count: ≥ 2 × 10\^9/L, platelet count: ≥ 100 × 10\^9/L; hemoglobin: ≥ 110 g/L; aspartate aminotransferase and alanine...
- With suspected breast disease (e.g., mastitis, malignant breast tumor) other than breast pain or benign breast cysts, or with other malignant tumors
- Use of hormonal medications (e.g., oral contraceptives, glucocorticoids, etc.), sex hormone modulators (SERMS, AIs, SERDs, etc.), B vitamins, essential oils, nonsteroidal anti-inflammatory drugs, or higher pain...
- Prior history of breast surgery (including minimally invasive surgery), history of malignancy, or history of thromboembolism within the last 5 years (history of varicose veins and superficial phlebitis allowed)
- Smokers; essential oils or placebo systemic/skin sensitization
- With serious primary diseases of the heart, liver, kidneys and hematopoietic system, or mental illness, etc.
- Accompanied by skin damage on the breast that destroys the stratum corneum (e.g., eczema, ulcers)
- Serious or uncontrolled infections that may interfere with study treatment or assessment of study results, including but not limited to active hepatitis viral infection, human immunodeficiency virus antibody positivity...
- people who are breastfeeding or pregnant at the time of screening (of childbearing age and with serum human chorionic gonadotropin test results higher than the reference value); people of childbearing age who have had...
- Decrease in total breast pain score by more than 25% during the placebo lead-in cycle. These patients will not receive subsequent randomization and treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.