NCT06966245

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mastalgia

Interventions

Type	Name	Description
DRUG	mastalgia-oil	External mastalgia-oil 1 ml/d per breast for 3 consecutive menstrual cycles
DRUG	Mastalgia-oil placebo	External mastalgia-oil placebo 1 ml/d per breast for 3 consecutive menstrual cycles

Timeline

• Start date: 2025-06-08
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2025-05-11
• Last updated: 2026-02-02

Locations

1 site across 1 country: China