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Trial · NCT00564850

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryNumber of Participants With a GnRH-stimulated LH Level ≤3 IU/L3 months after the first injection of triptorelin pamoate 11.25 mg
SecondaryNumber of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/LMonth 6
SecondaryFollicle Stimulating Hormone (FSH) Level Following GnRH TestScreening, month 3 and 6
SecondaryBasal FSH LevelMonth 0, 1, 2, 3, 4, 5, and 6
SecondaryBasal LH LevelMonth 0, 1, 2, 3, 4, 5 and 6
SecondaryNumber of Girls With Oestradiol Levels ≤ 20 pg/mlMonth 0, 1, 2, 3, 4, 5 and 6
SecondaryTestosterone LevelMonth 0, 3 and 6
SecondaryNumber of Girls With Inhibin B Levels < 6 pg/mlMonth 0, 3 and 6
SecondaryChange From Screening in Pubertal Stage (Tanner Method) at Month 6Between screening and month 6
Pubertal stage (graded from 1 to 5 for penis and breast development, graded from 1 to 6 for pubic hair development) according to the Tanner method was collected. A low stage (i.e. 1) corresponds to a pre-pubertal stage and a high stage (i.e. 5 or 6) to an adult stage. Any increase of grade was defined as 'increased' and no change in grade or a reduced grade was defined as 'stabilised or reduced'.
SecondaryHeight Standard Deviation Score (SDS)Month 0, 3 and 6
Standard deviation (SD) is a standard term used in growth studies and represents Standard Deviations calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child.
SecondaryBody Mass Index (BMI) SDSMonth 0, 3 and 6
SecondaryChange From Baseline in Growth Velocity (GV) SDS at Month 6Baseline and month 6
Change from baseline of GV was calculated as: GV at month 6 - GV at baseline. GV SDS was calculated using SAS algorithm. Growth velocity during the study was calculated using the two height measures as: GV = (Height at baseline - Height at screening)\*365/delay between two height measures.
SecondaryDifference Between Bone Age and Chronological AgeMonth 0 and 6Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.
SecondaryUterine LengthMonth 0, 3 and 6
SecondaryTriptorelin Plasma LevelsMonth 1, 2, 3, 4, 5 and 6

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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