NCT06404775

External Mastalgia-oil Versus Oral Tamoxifen in Premenopausal Women with Severe Mastalgia

External Mastalgia-oil Versus Oral Tamoxifen in Premenopausal Women with Severe Mastalgia: a Double-blind, Double-simulated, Positive-controlled Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 456 (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, double-simulated, positive-controlled, randomized clinical trial to explore the efficacy and safety of external mastalgia-oil versus oral tamoxifen in premenopausal women with severe mastalgia.

Conditions

• Mastalgia

Interventions

Type	Name	Description
DRUG	mastalgia-oil, tamoxifen placebo	external mastalgia-oil 1 ml/d per breast plus oral tamoxifen placebo 10mg/d for 3 consecutive menstrual cycles
DRUG	mastalgia-oil placebo, tamoxifen	oral tamoxifen 10mg/d plus external mastalgia-oil placebo 1 ml/d per breast for 3 consecutive menstrual cycles

Timeline

• Start date: 2025-01-16
• Primary completion: 2029-01-16
• Completion: 2030-05-16
• First posted: 2024-05-08
• Last updated: 2024-11-29

Locations

1 site across 1 country: China