Trial · NCT05493709
Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
NCT05493709, Phase 3, Completed, Foresee Pharmaceuticals Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty. Trials, record NCT05493709. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05493709
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
- NCT number
- NCT05493709
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 94 participants, actual
- Lead sponsor
- Foresee Pharmaceuticals Co., Ltd.
- Conditions
- Puberty; Precocious, Central
- Interventions
- Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide
- First posted
- 2022-08-09
- Last updated
- 2026-07-20
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Leuprolide Mesylate (FP-001 42 mg) | 48 weeks | The percentage of patients with serum LH concentrations \< 4 mIU/mL 60 minutes following an abbreviated GnRHa stimulation test at Visit 6 (Week 24). |
| Secondary | Effect of FP-001 42 mg on bone age progression | 24 and 48 weeks | Evaluate the changes in bone age progression from the baseline to Weeks 24 and 48 using centralized analysis of wrist x-ray |
| Secondary | Effect of FP-001 42 mg on growth rate | 48 weeks | Evaluate the changes in growth rate and bone age advancement relative to chronological age from baseline to end of study using height in meters |
| Secondary | Effect of FP-001 42 mg on physical signs of puberty | 48 weeks | Evaluate the change in physical signs of puberty as measure by Tanner stages from baseline to end of study |
| Secondary | Effect of FP-001 42 mg on suppression of physical signs of puberty | 48 weeks | Evaluate the percentage of patients with suppression of physical signs of puberty |
| Secondary | Acute-On-Chronic (AOC) phenomenon of serum testosterone and LH | 48 weeks | Evaluate The proportion of subjects exhibiting "acute-on-chronic" phenomenon (i.e., related to the second dose of FP-001 42 mg) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05493709
GET https://conductscience.org/api/trials/v1/NCT05493709/registered