drugset / Trial / NCT04616430
Topical Endoxifen in Women
RandomizedParallel-groupTriple-blindTreatment
Summary
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.
Timeline
- Start
- 2018-04-09
- Primary completion
- 2018-09-10
- Completion
- 2019-09-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Endoxifen | Small molecule | 10 mg | Topical |
| Comparator | Endoxifen | Small molecule | 20 mg | Topical |