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Trial · NCT06025409

Evaluate the Efficacy and Safety of DWJ108J

NCT06025409, Phase 3, Unknown, Daewoong Pharmaceutical Co. LTD.

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Evaluate the Efficacy and Safety of DWJ108J. Trials, record NCT06025409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06025409

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Evaluate the Efficacy and Safety of DWJ108J
NCT number
NCT06025409
Status
Unknown
Phases
Phase 3
Enrollment
79 participants, estimated
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Conditions
Central Precocious Puberty
Interventions
Leuprolide Acetate 11.25 MG/ML
First posted
2023-09-06
Last updated
2023-09-06

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPercentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.6 monthsLuteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.
SecondaryPercentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months.3 monthsLuteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.
SecondaryAverage LH and FSH concentrations at each time point, and the changes from baseline levels before administration.Baseline, 3 and 6 monthsAverage LH and FSH concentrations at each time point, and the changes from baseline levels before administration.
SecondaryAverage LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration3 and 6 monthsAverage LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration
SecondaryAverage concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.Baseline, 3 and 6 monthsAverage concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.
SecondaryAverage bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.6 monthsAverage bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.
SecondaryAverage Tanner Stage at 6 months after administration, and the changes compared to before administration.6 monthsAverage Tanner Stage at 6 months after administration, and the changes compared to before administration.
SecondaryAverage growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.6 monthsAverage growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT06025409

GET https://conductscience.org/api/trials/v1/NCT06025409/registered