Karolinska Institutet
Stockholm, Sodersjukhuset, Sweden
NCT Number: NCT04616430
Karma CREME-1 consisted of 90 participants from the Karma Cohort. The major focus of the pilot trial was to estimate time to mammographic density change. The primary objective was to determine the effect size of the breast density change between topical placebo and two doses of topical endoxifen.
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Notify Me40 year–74 year
Female
Interventional
Phase 2
Stockholm, Sodersjukhuset, Sweden
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
topical solution
topical
Time frame: From baseline to study exit up to 6 months
Change, on an individual level, in mammographic breast density, measured at 6 months or when exiting from the study (baseline screening mammography)
Atossa Therapeutics, Inc.
Industry
Karma CREME-1: A Double-blind, Placebo-controlled, Three-armed, Pilot Study of the Effects, Safety and Tolerability of Topical Endoxifen in Women Within the Karma Cohort
Acronym: CREME
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