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NCT02452931 · ClinicalTrials.gov registry record · Phase 3
Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
A Phase 3 study of Precocious Puberty, Central, sponsored by Tolmar.
- Completed
- Registry status
- Phase 3
- Development phase
- 64
- Enrollment target
- 20
- Study locations
NCT02452931: Completed Phase 3 study of Precocious Puberty, Central, sponsored by Tolmar.
NCT02452931 is a Phase 3 study of Precocious Puberty, Central that has completed, run by Tolmar. The registered enrollment target is 64 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02452931, a Phase 3 study of Precocious Puberty, Central, has completed, sponsored by Tolmar.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 64 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.
Primary Outcome
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \<4 IU/L. Peak stimulated LH refers to the maximum LH concentration measured 30 minutes after a gonadotropin-releasing hormone agonst (GnRHa) stimulation test.
Conditions Studied
Interventions
- DRUG Leuprolide Acetate 45 mg
Study Locations (20)
Other
- Hospital de Ninos - Buenos Aires
- CHU de Quebec-Universite Laval - Québec
- Instituto de Investigaciones Aplicadas a la Neurociencia, A.C. - Durango
- The Liggins Institute, University of Auckland - Auckland
Florida
- Joe DiMaggio Children's Hospital - Hollywood
- Nemours Children's Clinic - Jacksonville
- Nemours Children's Hospital - Orlando
Washington
- Seattle Children's - Seattle
- MultiCare Institute for Research and Innovation - Tacoma
Santiago Metropolitan
- Pontificia Universidad Catolica de Chile - Santiago
- Instituto de Investigaciones Materno Infantil (IDIMI) - Santiago
California
- University of California, San Diego - San Diego
Indiana
- Riley Hospital for Children at Indiana University Health - Indianapolis
Minnesota
- University of Minnesota - Minneapolis
Ohio
- Cincinnati Children's Hospital Medical Center, Endocrine - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2015-08-31 |
| Est. Completion | 2018-09-05 |
| Phase | Phase 3 |
What the finished NCT02452931 record still lists
NCT02452931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Precocious Puberty, Central appearing as the primary indexed condition, and to 1 intervention - of which Leuprolide Acetate 45 mg is the first listed.
NCT02452931 names 20 study sites across 13 states, led by Other, Florida, Washington.
Frequently Asked Questions
What is clinical trial NCT02452931 about?
NCT02452931 is a clinical study titled "Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty". This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.
What is the current status of trial NCT02452931?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 64 participants. The study started on 2015-08-31. Estimated completion is 2018-09-05.
What conditions does trial NCT02452931 study?
This clinical trial studies the following conditions: Precocious Puberty, Central.
What interventions are being tested in trial NCT02452931?
The interventions under investigation include: Leuprolide Acetate 45 mg (DRUG).
Who is sponsoring clinical trial NCT02452931?
This trial is sponsored by Tolmar, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02452931 being conducted?
This trial has 20 study locations across California, Florida, Indiana, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02452931's enrollment target sits among peer trials
64 1799th of 2000 higher than 201 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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