Clinical Trial: NCT03346200
Low Dose Tamoxifen for Mammographic Density Reduction
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Per Hall |
| Information Provided By: | Karolinska Institutet |
| Last Update Posted: | 2025-03-07 |
Study Overview
Brief 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.
Official Title
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
Conditions
Risk Reduction, Mammographic Density Reduction
Intervention / Treatment
- Drug: Tamoxifen Oral Tablet
- Drug: Placebo Oral Tablet
Other Study ID Numbers
- 2016-000882-22
- 2016
Start Date (Actual)
2016-11
Primary Completion Date (Actual)
2019-10
Study Completion Date (Actual)
2019-12
Enrollment (Actual)
1440
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Per Hall |
| Information Provided By: | Karolinska Institutet |
| Last Update Posted: | 2025-03-07 |
Study Overview
Brief 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.
Official Title
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
Conditions
Risk Reduction, Mammographic Density Reduction
Intervention / Treatment
- Drug: Tamoxifen Oral Tablet
- Drug: Placebo Oral Tablet
Other Study ID Numbers
- 2016-000882-22
- 2016
Start Date (Actual)
2016-11
Primary Completion Date (Actual)
2019-10
Study Completion Date (Actual)
2019-12
Enrollment (Actual)
1440
Study Type
Interventional
Phase
Phase 2