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Trial · NCT05029622

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage of Participants With Luteinising Hormone (LH) SuppressionAt Month 6The ITT population consisted of all participants who received at least 1 dose of study intervention.percentage of participantsNUMBER
SECONDARYPercentage of Participants With LH Response to GnRH TestAt Months 3 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.percentage of participantsNUMBER
SECONDARYChange From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) LevelsBaseline and at Months 3, 6, 9 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.IU/LMEAN
SECONDARYChange From Baseline in Peak Serum LH and FSH Level After the GnRH Stimulation TestBaseline and at Months 3, 6 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.IU/LMEAN
SECONDARYPercentage of Participants With LH Response (Peak LH <=5 IU/L) From Month 6 to Month 12Month 6 to Month 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.percentage of participantsNUMBER
SECONDARYPercentage of Participants With Prepubertal Levels of Sex SteroidsAt Months 3, 6, 9 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.percentage of participantsNUMBER
SECONDARYChange From Baseline in Mean Height for Age (Z-Score)Baseline and at Months 6 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.Z-scoreMEAN
SECONDARYChange From Baseline in Percentile for Height for AgeBaseline and at Months 6 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.percentiles of Z-scoreMEAN
SECONDARYChange From Baseline in Growth VelocityBaseline and at Months 6 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.centimeter (cm)/yearMEAN
SECONDARYPercentage of Participants With Bone Age (BA)/Chronological Age (CA) Ratio Not RisenAt Months 6 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.percentage of participantsNUMBER
SECONDARYChange From Baseline in BA:CA RatioBaseline, Months 6 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.ratioMEAN
SECONDARYPercentage of Participants With Stabilized Pubertal StageAt Months 6 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.percentage of participantsNUMBER
SECONDARYPercentage of Participants With Regression of Uterine LengthAt Months 6 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the female participants analyzed were reported.percentage of participantsNUMBER
SECONDARYPercentage of Participants With Absence of Progression of Testis VolumesAt Months 6 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the male participants analyzed were reported.percentage of participantsNUMBER
SECONDARYChange From Baseline in Body Mass Index (BMI)Baseline and at Months 6 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.kilogram (kg)/meter squareMEAN
SECONDARYChange From Baseline in WeightBaseline and at Months 6 and 12The ITT population consisted of all participants who received at least 1 dose of study intervention. Only data from the participants analyzed were reported.kgMEAN
SECONDARYPlasma Concentrations of TriptorelinDay 1, 4 hours post-injection; Month 3; Month 6, predose; Month 6, 4 hours post-injection; and Month 12
The Pharmacokinetic (PK) set consisted of all participants who received at 1 dose of study treatment and had at least 1 valid triptorelin concentration. Only data from the participants analyzed were reported.
ng/mLGEOMETRIC_MEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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