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Topical Endoxifen in Women

NCT04616430 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-07-12

Study results available
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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.

Conditions

  • Mammographic Breast Density

Interventions

DRUG

Topical endoxifen

topical solution

DRUG

Placebo

topical

Sponsors & Collaborators

Principal Investigators

  • Per Hall, MD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-09
Primary Completion
2018-09-10
Completion
2019-09-04

Countries

  • Sweden

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04616430 on ClinicalTrials.gov