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Low Dose Tamoxifen for Mammographic Density Reduction

NCT03346200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1440

Last updated 2025-03-07

Study results available
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Summary

KARISMA2 is a randomized, double-blinded, six-armed placebo controlled study to identify a low dose of tamoxifen, with less side-effects and a density reduction non-inferior to the standard dose of 20 mg.

Conditions

  • Risk Reduction
  • Mammographic Density Reduction

Interventions

DRUG

Tamoxifen Oral Tablet

Randomised dose of tamoxifen 1 pill/day for 180 days

DRUG

Placebo Oral Tablet

Randomised dose of tamoxifen 1 pill/day for 180 days

Sponsors & Collaborators

  • Per Hall

    lead OTHER

Principal Investigators

  • Per Hall, Professor · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-10-31
Completion
2019-12-31

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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 NCT03346200 on ClinicalTrials.gov