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NCT05493709 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
A Phase 3 study of Puberty; Precocious, Central, sponsored by Foresee Pharmaceuticals Co..
- Active
- Registry status
- Phase 3
- Development phase
- 93
- Enrollment target
- 20
- Study locations
NCT05493709: Active Phase 3 study of Puberty; Precocious, Central, sponsored by Foresee Pharmaceuticals Co..
NCT05493709 is a Phase 3 study of Puberty; Precocious, Central that is active but no longer recruiting, run by Foresee Pharmaceuticals Co.. The registered enrollment target is 93 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05493709, a Phase 3 study of Puberty; Precocious, Central, is active but no longer recruiting, sponsored by Foresee Pharmaceuticals Co..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 93 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with central (gonadotropin-dependent) precocious puberty, when administered as two injections six months apart.
Primary Outcome
The percentage of patients with serum LH concentrations \< 4 mIU/mL 60 minutes following an abbreviated GnRHa stimulation test at Visit 6 (Week 24).
Conditions Studied
Interventions
- DRUG Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide
Study Locations (20)
Guangdong
- Pearl River Hospital, Southern Medical University - Guangzhou
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University - Guangzhou
- The First Affiliated Hospital, Sun Yat-sen University - Guangzhou
- The Third Affiliated Hospital, Sun Yat-Sen University - Guangzhou
Florida
- Nemours Children's Health Center - Jacksonville
- Johns Hopkins - All Children's Hospital - St. Petersburg
Texas
- University of Texas Southwestern Medical Center - Dallas
- Cook Children's - Fort Worth
Hubei
- Tongji Hospital, Tongji Medical College of HUST - Wuhan
- Wuhan Children's Hospital, Tongji Medical College of HUST - Wuhan
Arizona
- Arizona University - Tucson
California
- Rady Children's Hospital- San Diego - San Diego
Idaho
- Rocky Mountain Clinical Research - Idaho Falls
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2023-06-02 |
| Est. Completion | 2026-06 |
| Phase | Phase 3 |
What the registry record for NCT05493709 still lists
NCT05493709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Puberty; Precocious, Central appearing as the primary indexed condition, and to 1 intervention - of which Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide is the first listed.
NCT05493709 names 20 study sites across 14 states, led by Guangdong, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT05493709 about?
NCT05493709 is a clinical study titled "Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty". The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with central (gonadotropin-dependent) precocious puberty, when administered as two injections six months apart.
What is the current status of trial NCT05493709?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 93 participants. The study started on 2023-06-02. Estimated completion is 2026-06.
What conditions does trial NCT05493709 study?
This clinical trial studies the following conditions: Puberty; Precocious, Central.
What interventions are being tested in trial NCT05493709?
The interventions under investigation include: Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide (DRUG).
Who is sponsoring clinical trial NCT05493709?
This trial is sponsored by Foresee Pharmaceuticals Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05493709 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Idaho, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05493709's enrollment target sits among peer trials
93 1723rd of 2000 higher than 278 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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