drugset / Trial / NCT04079517

Karolinska Interventional Study of Mammograhic Density (Karisma-1)

NCT04079517

Phase 1/2 Completed 42 enrolled Karolinska Institutet
RandomizedParallel-groupTriple-blindPrevention

Summary

A feasibility study, randomising to either 10 or 20 mg of tamoxifen. The primary aim is to identify the time to mammographic density change and piloting the procedures. It is known that a density change is seen after 12 months of 20 mg of tamoxifen, but the clinical experience indicates that an effect of drugs influencing mammographic density could be seen already after a few months. The second aim is to evaluate if there is a density change from 10 mg of tamoxifen equivalent to 20 mg.

Timeline

Start
2015-03
Primary completion
2016-02
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Tamoxifen Small molecule 10 mg Oral
Subject Tamoxifen Small molecule 20 mg Oral

Indications