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ACTIVE NOT RECRUITING
NCT05068388
PHASE2

Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density

Sponsor: Atossa Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a randomized, double-blinded, placebo-controlled dose-response efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density. There will be 5 in-clinic visits (Screening, Day 1, Months 1, 3 and 6) and 3 self-report visits (Months 2, 4 and 5). Standard of care mammograms will be used for the screening mammogram as well as the 24-month follow up visit.

Official title: A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-Response Study of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density

Key Details

Gender

FEMALE

Age Range

40 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2021-12-21

Completion Date

2025-12-31

Last Updated

2024-04-26

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Z-Endoxifen

Z-Endoxifen

DRUG

Placebo

Placebo

Locations (1)

Karma Study Centre

Stockholm, Sweden