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NOT YET RECRUITING
NCT07869732
PHASE2

(Z)-Endoxifen in Girls With MAS-Associated Peripheral Precocious Puberty

Sponsor: Atossa Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, and blood levels of (Z)-endoxifen in girls with McCune-Albright Syndrome that have peripheral precocious puberty. The main question it aims to answer \[is/are\]: Are there any safety concerns? Is there any evidence of efficacy? There is no comparison group. Participants will: * take a capsule once a day for 3 months; * have doctor visits (tele-health and in-person); * blood samples collected; and * complete questionnaires

Official title: A Phase 2 Open-Label, Safety, Tolerability and Exposure Study of Oral (Z)-Endoxifen for the Treatment of Gonadotropin-Independent Precocious Puberty in Girls With McCune-Albright Syndrome

Key Details

Gender

FEMALE

Age Range

4 Years - 9 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2027-03

Completion Date

2028-09

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

DRUG

(Z)-endoxifen

(Z)-endoxifen will be administered once daily via the oral route

Locations (1)

NIH

Bethesda, Maryland, United States