At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,440 enrolled
Drug / intervention
Tamoxifen Oral Tablet +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double Blinded, Six-armed Placebo Controlled Study to Investigate Optimal Dose of Tamoxifen With the Most Favourable Side Effect Spectre and With Mammography Density Reduction Non-inferior to That of 20 mg Tamoxifen
In Brief
A Phase 2 clinical trial evaluating Tamoxifen Oral Tablet and Placebo Oral Tablet for Risk Reduction and Mammographic Density Reduction. Completed, enrolled 1,440 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRisk Reduction, Mammographic Density Reduction
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartNov 2016
First PostedNov 2017
Primary CompletionOct 2019
Study CompletionDec 2019
TodayJul 2026
First PostedNov 17, 2017
Enrollment StartNov 1, 2016
Primary CompletionOct 1, 2019
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.6 years ago
Interventions
Tamoxifen Oral Tabletdrug
Randomised dose of tamoxifen 1 pill/day for 180 days
Placebo Oral Tabletdrug
Randomised dose of tamoxifen 1 pill/day for 180 days