drugset / Trial / NCT04498013

Study of the Effects of Cyclodynon on Reducing the Cumulative Risk of Breast Cancer Development in a Female Aged 40-52

NCT04498013 ↗

Phase 4 Unknown 150 enrolled Dr. Struk Tetiana Bionorica SE · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Increased mammographic density of mammary gland tissues and hyperprolactinaemia are regarded as one of the risk factors for the development of breast cancer in women aged 40 to 52 years, which necessitates closer monitoring of the mammary gland and can be considered as modifiable. The herbal drug Cyclodynone® has a dopaminergic effect on the hypothalamus, which causes its inhibitory effect on the secretion of prolactin. At present, a significant positive clinical and scientific experience has been accumulated in the use of the Cyclodynone® for the treatment of benign breast dysplasias against a background of mild hyperprolactinaemia in women of reproductive age. Demonstration of the positive effect of this drug on the reduction of hyperprolactinemia, mammographic density of MF, evaluation on the scale BI-RADS would justify its application for the modification of this risk factor in women aged 40 to 52 years.

Timeline

Start
2020-07-22
Primary completion
2022-04-01
Completion
2022-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclodynon Traditional medicine (herbal / TCM) 1 unknown —

Indications