Trials / Completed
CompletedNCT04616430
Topical Endoxifen in Women
Karma CREME-1: A Double-blind, Placebo-controlled, Three-armed, Pilot Study of the Effects, Safety and Tolerability of Topical Endoxifen in Women Within the Karma Cohort
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Atossa Therapeutics, Inc. · Industry
- Sex
- Female
- Age
- 40 Years – 74 Years
- Healthy volunteers
- Accepted
Summary
Karma CREME-1 consisted of 90 participants from the Karma Cohort. The major focus of the pilot trial was to estimate time to mammographic density change. The primary objective was to determine the effect size of the breast density change between topical placebo and two doses of topical endoxifen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Topical endoxifen | topical solution |
| DRUG | Placebo | topical |
Timeline
- Start date
- 2018-04-09
- Primary completion
- 2018-09-10
- Completion
- 2019-09-04
- First posted
- 2020-11-05
- Last updated
- 2021-07-12
- Results posted
- 2021-06-18
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT04616430. Inclusion in this directory is not an endorsement.