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(Z)-Endoxifen for Precocious Puberty

Age: < 18
Sex: Female
Trial Phase: Phase 2
Sponsor: Atossa Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

AB

Alison Boyce, MD

Principal Investigator

Lasker Clinical Research Scholar Chief, Metabolic Bone Disorders Unit National Institute of Dental and Craniofacial Research National Institutes of Health

Are You a Good Fit for This Trial?

This trial is for girls diagnosed with McCune-Albright Syndrome who are experiencing early puberty not caused by the brain. Participants should be able to take daily medication and attend regular doctor visits.

Inclusion Criteria

I have McCune-Albright syndrome with early puberty and another symptom besides skin spots.
Prepubertal or low-normal basal luteinizing hormone (LH) and follicle-stimulating hormone (FSH), consistent with predominantly gonadotropin-independent disease activity
Advanced bone age, defined as bone age exceeding chronological age by ≥1 year at screening, determined using the protocol-specified standardized radiographic method and central or qualified local reading procedures
See 8 more

Exclusion Criteria

Pregnancy or breastfeeding; pregnancy testing applies only to post-menarche or otherwise at-risk participants as medically and ethically appropriate
Any serious concomitant medical, developmental, behavioral, or psychiatric condition that, in the Investigator's judgment, would make participation unsafe, prevent reliable completion of study procedures, or compromise study integrity
ALT or AST >3 × upper limit of normal (ULN), total bilirubin >2 × ULN, or other clinically significant hepatic impairment at screening (post-letrozole 14 day wash-out), unless the abnormality is explained, stable, and approved by the Sponsor Medical Monitor
See 13 more

What Are the Treatments Tested in This Trial?

Interventions

  • (Z)-Endoxifen

Trial Overview

(Z)-endoxifen, taken as a daily capsule for 3 months, is being studied to see if it is safe and effective in treating early puberty in girls with MAS. There is no comparison group; all participants receive the study drug.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: (Z)-endoxifen armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Atossa Therapeutics, Inc.

Lead Sponsor

Trials
8
Recruited
640+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials
312
Recruited
853,000+

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