NCT06966245 External Mastalgia-oil Versus Placebo in Premenopausal Women With Severe Mastalgia
| NCT ID | NCT06966245 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Mastalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2025-06-08 |
| Primary Completion | 2027-06-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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, platele