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NOT YET RECRUITING
NCT06404775
PHASE3

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

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

456

Start Date

2025-01-16

Completion Date

2030-05-16

Last Updated

2024-11-29

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

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

Guangzhou, Guangdong, China