New oil could ease severe breast pain without pills
NCT ID NCT06966245
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if an external oil can reduce severe breast pain in premenopausal women. About 190 women will apply either the oil or a placebo for three menstrual cycles. The main goal is to see if the oil cuts pain by at least half. This is a phase 3 trial, meaning it's in the final testing stage before possible approval.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 190 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2025
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 wall pain in the baseline menstrual cycle (nonmedicated menstrual cycle) * 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 drug; negative pregnancy test in females of childbearing potential * 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 aminotransferase: ≤ upper limit of normal, alkaline phosphatase: ≤ upper limit of normal, blood total bilirubin: ≤ upper limit of normal; serum creatinine and blood urea nitrogen: ≤ upper limit of normal Exclusion Criteria: * 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 relievers in the past 3 months; use of tamoxifen or analogs in the past 6 months * 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, syphilis spirochete antibody positivity with evidence of active infection, and pulmonary infections * Subjects 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); subjects of childbearing age who have had unprotected sex with a heterosexual partner within 2 weeks prior to the screening; subjects of childbearing age who are planning to prepare for conception, become pregnant, breastfeed, or donate their eggs during the test period or within 3 months of the end of the test; and those with implanted breasts * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Mastalgia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
RECRUITINGGuangzhou, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.