External Mastalgia-oil Versus Placebo in Premenopausal Women With Severe Mastalgia

January 29, 2026 updated by: Chang Gong, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

External Mastalgia-oil Versus Placebo in Premenopausal Women With Severe Mastalgia: a Double-blind, Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: External mastalgia-oil
Drug: mastalgia-oil
External mastalgia-oil 1 ml/d per breast for 3 consecutive menstrual cycles
Placebo Comparator: Mastalgia-oil placebo
Drug: Mastalgia-oil placebo
External mastalgia-oil placebo 1 ml/d per breast for 3 consecutive menstrual cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mastalgia clinical response rate
Time Frame: Within 4 weeks after the end of the third treatment menstrual cycle
The recruited patients with mastalgia will be asked to record their symptoms of breast pain using a daily VAS breast pain chart, and the sum of the daily VAS within a menstrual cycle is considered the breast pain score (BPS). Effective rate (%)= [BPS (P) - BPS (T3)]/BPS (P)*100%, where BPS (P) indicates BPS of the placebo lead-in cycle and BPS (T3) indicates BPS at the end of the third treatment cycle. An effective rate of ≥50% is considered a clinical response.
Within 4 weeks after the end of the third treatment menstrual cycle

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subgroup mastalgia clinical response rate
Time Frame: Within 4 weeks after the end of the third treatment menstrual cycle
Mastalgia clinical response rate in women with cyclical mastalgia; Mastalgia clinical response rate in women with non-cyclical mastalgia
Within 4 weeks after the end of the third treatment menstrual cycle
Breast nodularity
Time Frame: Within 7 days before the first treatment and the end of each treatment menstrual cycle
Breast nodularity will be assessed according to the Lucknow-Cardiff breast nodularity scale.The above breast nodularity scale is a 5-point ordinal scale depicting increasing order of nodularity in upper outer quadrants of the breasts. Grade-0 depicts a smooth textured breast with extreme extent of normalcy and grade-4 the maximum nodularity.
Within 7 days before the first treatment and the end of each treatment menstrual cycle
Pharmacokinetics of mastodynia-oil
Time Frame: Within 4 weeks after the end of the third treatment menstrual cycle
Collection of blood samples for pharmacokinetic trough concentration-effect analysis of mastodynia-oil
Within 4 weeks after the end of the third treatment menstrual cycle
Changes in blood metabolites
Time Frame: Within 4 weeks after the end of the third treatment menstrual cycle
Comparison of changes in blood metabolites before and after treatment and their correlation with primary endpoints using metabolomics.
Within 4 weeks after the end of the third treatment menstrual cycle
Safety (AEs+SAEs)
Time Frame: From signing the informed consent form until 28 days after completion of treatment
Safety will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
From signing the informed consent form until 28 days after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 2, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RELIEF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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