Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-03-03 @ 12:20 AM
Study NCT ID:
NCT00564850
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2007-11-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011629', 'term': 'Puberty, Precocious'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017329', 'term': 'Triptorelin Pamoate'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@ipsen.com', 'title': 'Medical Director, Endocrinology', 'organization': 'Ipsen'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.', 'otherNumAtRisk': 37, 'otherNumAffected': 7, 'seriousNumAtRisk': 37, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Yes [ITT (n=37)]', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '68.0', 'upperLimit': '93.8'}]}]}, {'title': 'No [ITT (n=37)]', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Yes [mITT (n=34)]', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '76.3', 'upperLimit': '98.1'}]}]}, {'title': 'No [mITT (n=34)]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Yes [PP (n=32)]', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '99.2'}]}]}, {'title': 'No [PP (n=32)]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months after the first injection of triptorelin pamoate 11.25 mg', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses performed on:\n\n* Intention to Treat (ITT): all patients having received ≥1 injection. Any subject with missing data is considered a non-responder.\n* Modified ITT (mITT): all ITT patients with ≥ Month 3 post-baseline assessment of primary efficacy criterion.\n* Per Protocol (PP): all mITT patients without major protocol deviations.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Yes (n=37)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '71.2', 'upperLimit': '95.5'}]}]}, {'title': 'No (n=37)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Intention to Treat population (ITT) defined as all participants having received at least one injection of 11.25 mg triptorelin pamoate. "n" indicates the number of patients who had an assessment at the visit.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Follicle Stimulating Hormone (FSH) Level Following GnRH Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Screening (n=37)', 'categories': [{'measurements': [{'value': '11.84', 'spread': '3.23', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=34)', 'categories': [{'measurements': [{'value': '2.26', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=35)', 'categories': [{'measurements': [{'value': '2.34', 'spread': '1.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, month 3 and 6', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population. 3 participants and 2 participants had missing data at month 3 and month 6 respectively.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Basal FSH Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Month 0 (screening, n=37)', 'categories': [{'measurements': [{'value': '4.13', 'spread': '2.65', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 (n=35)', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.53', 'groupId': 'OG000'}]}]}, {'title': 'Month 2 (n=36)', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=35)', 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.73', 'groupId': 'OG000'}]}]}, {'title': 'Month 4 (n=35)', 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.39', 'groupId': 'OG000'}]}]}, {'title': 'Month 5 (n=34)', 'categories': [{'measurements': [{'value': '1.41', 'spread': '2.09', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=35)', 'categories': [{'measurements': [{'value': '1.36', 'spread': '1.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0, 1, 2, 3, 4, 5, and 6', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Basal LH Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Month 0 (screening, n=37)', 'categories': [{'measurements': [{'value': '1.49', 'spread': '1.78', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 (n=35)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.22', 'groupId': 'OG000'}]}]}, {'title': 'Month 2 (n=36)', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=35)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.27', 'groupId': 'OG000'}]}]}, {'title': 'Month 4 (n=35)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.23', 'groupId': 'OG000'}]}]}, {'title': 'Month 5 (n=34)', 'categories': [{'measurements': [{'value': '0.48', 'spread': '0.70', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=35)', 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0, 1, 2, 3, 4, 5 and 6', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Number of Girls With Oestradiol Levels ≤ 20 pg/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Yes - month 0 (n=36)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'No - month 0 (n=36)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Yes - month 1 (n=34)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '99.9'}]}]}, {'title': 'No - month 1 (n=34)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Yes - month 2 (n=35)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '99.9'}]}]}, {'title': 'No - month 2 (n=35)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Yes - month 3 (n=34)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '84.7', 'upperLimit': '99.9'}]}]}, {'title': 'No - month 3 (n=34)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Yes - month 4 (n=34)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '100'}]}]}, {'title': 'No - month 4 (n=34)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Yes - month 5 (n=33)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '89.4', 'upperLimit': '100'}]}]}, {'title': 'No - month 5 (n=33)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Yes - month 6 (n=34)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '84.7', 'upperLimit': '99.9'}]}]}, {'title': 'No - month 6 (n=34)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0, 1, 2, 3, 4, 5 and 6', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 participant and 3 participants had missing data at month 2 and 5 respectively.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Testosterone Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Month 0 (screening)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0, 3 and 6', 'unitOfMeasure': 'ng/ml', 'reportingStatus': 'POSTED', 'populationDescription': 'Testosterone level from the male patient in the ITT population.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Number of Girls With Inhibin B Levels < 6 pg/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Yes - month 0 (screening, n=36)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'No - month 0 (screening, n=36)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Yes - month 3 (n=34)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '84.7', 'upperLimit': '99.9'}]}]}, {'title': 'No - month 3 (n=34)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Yes - month 6 (n=34)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '80.3', 'upperLimit': '99.3'}]}]}, {'title': 'No - month 6 (n=34)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0, 3 and 6', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and month 6.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Change From Screening in Pubertal Stage (Tanner Method) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Pubic hair stage stabilised or reduced (n=35)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Pubic hair stage increased (n=35)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Breast stage stabilised or reduced (n=34)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Breast stage increased (n=34)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Penis stage stabilised or reduced (n=1)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Penis stage increased (n=1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between screening and month 6', 'description': "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'.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population. 2 participants had missing data for pubic hair stage and breast stage.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Height Standard Deviation Score (SDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Month 0 (baseline, n=37)', 'categories': [{'measurements': [{'value': '1.25', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=37)', 'categories': [{'measurements': [{'value': '1.32', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=35)', 'categories': [{'measurements': [{'value': '1.32', 'spread': '1.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0, 3 and 6', 'description': '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.', 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population. 2 participants had missing data at month 6.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Body Mass Index (BMI) SDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Month 0 (baseline, n=36)', 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=37)', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.89', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=35)', 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0, 3 and 6', 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population. 1 and 2 participants had missing data at month 0 and month 6 respectively.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Growth Velocity (GV) SDS at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.95', 'spread': '2.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and month 6', 'description': 'Change from baseline of GV was calculated as: GV at month 6 - GV at baseline. GV SDS was calculated using SAS algorithm.\n\nGrowth 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.', 'unitOfMeasure': 'SD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population. If GV at screening was missing, the value was derived from data recorded between 5 to 19 months ago otherwise GV at screening was considered missing. 9 participants had missing data.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Difference Between Bone Age and Chronological Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Month 0 (screening, n=37)', 'categories': [{'measurements': [{'value': '2.09', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=33)', 'categories': [{'measurements': [{'value': '2.02', 'spread': '0.88', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 and 6', 'description': 'Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ITT population. 33 participants were assessed. 4 participants had missing data at month 6.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Uterine Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Month 0 (screening, n=35)', 'categories': [{'measurements': [{'value': '37.6', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=34)', 'categories': [{'measurements': [{'value': '37.4', 'spread': '8.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=34)', 'categories': [{'measurements': [{'value': '36.8', 'spread': '6.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0, 3 and 6', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and 6.', 'anticipatedPostingDate': '2011-10'}, {'type': 'SECONDARY', 'title': 'Triptorelin Plasma Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'classes': [{'title': 'Month 1 (n=35)', 'categories': [{'measurements': [{'value': '0.187', 'spread': '0.115', 'groupId': 'OG000'}]}]}, {'title': 'Month 2 (n=36)', 'categories': [{'measurements': [{'value': '0.048', 'spread': '0.023', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=35)', 'categories': [{'measurements': [{'value': '0.034', 'spread': '0.018', 'groupId': 'OG000'}]}]}, {'title': 'Month 4 (n=34)', 'categories': [{'measurements': [{'value': '0.201', 'spread': '0.120', 'groupId': 'OG000'}]}]}, {'title': 'Month 5 (n=33)', 'categories': [{'measurements': [{'value': '0.045', 'spread': '0.023', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=35)', 'categories': [{'measurements': [{'value': '0.030', 'spread': '0.017', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 2, 3, 4, 5 and 6', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Pharmacokinetics (PK) Valid population defined as all participants who received at least one injection of 11.25 mg triptorelin pamoate and had at least one PK assessment. 2 participants had data missing at month 1,3 and 6. 1, 3 and 4 participants had data missing at month 2, 4 and 5 respectively.', 'anticipatedPostingDate': '2011-10'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': "62 participants were screened, of which 37 met the study's entry criteria and received at least one dose of investigational medicinal product. 25 participants failed screening. Participants were recruited from October 2007 at 18 Hospital clinics across France."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Triptorelin Pamoate 11.25 mg', 'description': '11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '1.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '32.76', 'spread': '7.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2007-11-27', 'resultsFirstSubmitDate': '2011-11-01', 'studyFirstSubmitQcDate': '2007-11-27', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-11-01', 'studyFirstPostDateStruct': {'date': '2007-11-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L', 'timeFrame': '3 months after the first injection of triptorelin pamoate 11.25 mg'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L', 'timeFrame': 'Month 6'}, {'measure': 'Follicle Stimulating Hormone (FSH) Level Following GnRH Test', 'timeFrame': 'Screening, month 3 and 6'}, {'measure': 'Basal FSH Level', 'timeFrame': 'Month 0, 1, 2, 3, 4, 5, and 6'}, {'measure': 'Basal LH Level', 'timeFrame': 'Month 0, 1, 2, 3, 4, 5 and 6'}, {'measure': 'Number of Girls With Oestradiol Levels ≤ 20 pg/ml', 'timeFrame': 'Month 0, 1, 2, 3, 4, 5 and 6'}, {'measure': 'Testosterone Level', 'timeFrame': 'Month 0, 3 and 6'}, {'measure': 'Number of Girls With Inhibin B Levels < 6 pg/ml', 'timeFrame': 'Month 0, 3 and 6'}, {'measure': 'Change From Screening in Pubertal Stage (Tanner Method) at Month 6', 'timeFrame': 'Between screening and month 6', 'description': "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'."}, {'measure': 'Height Standard Deviation Score (SDS)', 'timeFrame': 'Month 0, 3 and 6', 'description': '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.'}, {'measure': 'Body Mass Index (BMI) SDS', 'timeFrame': 'Month 0, 3 and 6'}, {'measure': 'Change From Baseline in Growth Velocity (GV) SDS at Month 6', 'timeFrame': 'Baseline and month 6', 'description': 'Change from baseline of GV was calculated as: GV at month 6 - GV at baseline. GV SDS was calculated using SAS algorithm.\n\nGrowth 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.'}, {'measure': 'Difference Between Bone Age and Chronological Age', 'timeFrame': 'Month 0 and 6', 'description': 'Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.'}, {'measure': 'Uterine Length', 'timeFrame': 'Month 0, 3 and 6'}, {'measure': 'Triptorelin Plasma Levels', 'timeFrame': 'Month 1, 2, 3, 4, 5 and 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Precocious Puberty']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria in the screening phase:\n\n* Onset of sex characteristics (Tanner method) breast development in girls or testicular enlargement in boys before the age of 8 years in girls and 9 years in boys.\n* Weight ≥ 20 kg.\n\nInclusion Criteria in the treatment phase:\n\n* Proven central precocious puberty defined as onset of sex characteristics development (according to Tanner method) diagnosed before the age of 8 years in girls and 9 years in boys.\n* Age at evaluation less than 9 years for girls and 10 years for boys.\n* A pubertal response of LH to GnRH test in both sexes (stimulated LH ≥ 5 IU/l).\n* Difference Bone age (BA) (according to Greulich et Pyle method) - Chronological age (CA) \\> 1 year.\n* Testosterone level ≥ 0.5 ng/ml in boys.\n\nExclusion Criteria:\n\n* Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion.\n* Patient with a cerebral tumour requiring a neurosurgery or cerebral irradiation.\n* Patient with a Body Weight ≥ 125% of the ideal weight for the height and age (growth curves).\n* The patient has received a previous treatment with a GnRH analogue, or medroxyprogesterone or cyproterone acetate.'}, 'identificationModule': {'nctId': 'NCT00564850', 'acronym': 'DECAPUB', 'briefTitle': 'Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'Phase III, Multicentre, Non-comparative, Open and Single Stage Study to Assess the Efficacy and Safety of Pamoate of Triptorelin 11.25 MG in Children With Precocious Puberty', 'orgStudyIdInfo': {'id': '2-54-52014-143'}, 'secondaryIdInfos': [{'id': '2005-005644-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triptorelin pamoate 11.25mg (Decapeptyl® SR)', 'interventionNames': ['Drug: Triptorelin pamoate 11.25mg (Decapeptyl® SR)']}], 'interventions': [{'name': 'Triptorelin pamoate 11.25mg (Decapeptyl® SR)', 'type': 'DRUG', 'description': 'One intra muscular injection at day 1 and month 3.', 'armGroupLabels': ['Triptorelin pamoate 11.25mg (Decapeptyl® SR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49033', 'city': 'Angers', 'country': 'France', 'facility': 'Hôpital Hotel-Dieu (CHU)', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Hôpital Saint-Jacques', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Medical Centre', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '21034', 'city': 'Dijon', 'country': 'France', 'facility': 'Hôpital du Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '76083', 'city': 'Le Havre', 'country': 'France', 'facility': 'Hôpital Flaubert', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Jeanne de Flandre', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69322', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Debrousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital de la Timone Enfants', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'Hôpital Archet 2', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital St-Vincent de Paul', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker - Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'American Memorial Hospital', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Hôpital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '67100', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpital Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '65013', 'city': 'Tarbes', 'country': 'France', 'facility': 'Hôpital de la Gespe', 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}, {'zip': '31026', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital des Enfants', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/members/ourmembers/', 'timeFrame': 'Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.', 'ipdSharing': 'YES', 'description': 'Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.\n\nAny requests should be submitted to www.vivli.org for assessment by an independent scientific review board.', 'accessCriteria': "Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}