(Z)-Endoxifen in Girls With MAS-Associated Peripheral Precocious Puberty
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- Atossa Therapeutics, Inc.
- Study ID
- NCT07869732
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Precocious Puberty, Gonadotropin-dependent
Eligibility Criteria
- Sex
- FEMALE
- Age
- 4 Years - 9 Years
- Healthy Volunteers
- Not accepted
Interventions
- (Z)-endoxifen — DRUG(Z)-endoxifen will be administered once daily via the oral route
Study Details
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
Key Dates
- First listed
- Oct 9, 2026
- Start date
- Mar 31, 2027
- Status verified
- Oct 2026
- Primary completion
- Jun 30, 2028
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 6 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: (Z)-endoxifen arm
Primary Outcome Measure
Safety and tolerability [ Time Frame: 3 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NIH | Bethesda | Maryland | 20817 | - |