Trials / Active Not Recruiting
Active Not RecruitingNCT05068388
Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density
A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-Response Study of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Atossa Therapeutics, Inc. · Industry
- Sex
- Female
- Age
- 40 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Z-Endoxifen | Z-Endoxifen |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2021-12-21
- Primary completion
- 2024-08-28
- Completion
- 2025-12-31
- First posted
- 2021-10-05
- Last updated
- 2024-04-26
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT05068388. Inclusion in this directory is not an endorsement.