Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT00988260
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japanese Bridging Trial of Org 37462 (Study P05969)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C061018', 'term': 'ganirelix'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 266}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2004-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2009-10-01', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Luteinizing Hormone (LH) rise', 'timeFrame': 'During treatment (1-14 days)'}, {'measure': 'Intrauterine vital pregnancy rate', 'timeFrame': '5-6 weeks after embryo transfer (ET)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Controlled Ovarian Stimulation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find the optimal dose of Org 37462 for Japanese females undergoing controlled ovarian stimulation for in vitro fertilization intracytoplasmic sperm injection (IVF-ICSI).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese females of infertile married couples with an indication for COH and IVF with or without ICSI.\n* At least 20 but not older than 39 years of age at the time of screening.\n* A body mass index (BMI) between 18 and 29.\n* Normal menstrual cycle with a range of 24-35 days and an intra-individual variation of plus or minus 3 days (but never outside the 24-35 days range).\n* Infertile couple that is willing to give written informed consent.\n* Determination of inclusion criteria\n\n * is determined in view of the planned therapeutic indication.\n * is determined based on ethical considerations for the subjects (not younger than 20) and also in view of the planned therapeutic indication (not older than 39)\n * is determined to avoid bias on the effects of Org 37462 by emaciation and obesity.\n * is determined to avoid the influences of endogenous hormones considering the purpose of this trial to select the minimal effective dose of Org 37462.\n * is determined from the ethical consideration of the subjects.\n\nExclusion Criteria:\n\n* History of/or current endocrine abnormality such as polycystic ovary syndrome (PCOS) or polycystic ovaries according to USS, (treated) hyperprolactinemia or evidence of ovarian dysfunction.\n* History of non- or low- ovarian response to FSH/hMG treatment.\n* Abnormal cervical smear according to the Papanicolaou (\\>= class III) or Bethesda (\\>= CIN 1) scale.\n* History of/or current Type I hypersensitivity (urticaria, eczema, hay fever, asthma), meaning that the subject is using prescribed medication on a regular basis or that the subjects history is prohibitive for Org 37462 treatment according to the clinical opinion of the sub-investigator.\n* Any hormone value outside the reference range during the early follicular phase as measured by the central laboratory (Japan) \\[FSH, LH, E2, P, androstenedione (AD), dehydroepiandrosterone sulphate (DHEAS), testosterone (T), thyroid stimulating hormone (TSH) and prolactin\\].\n* Any clinically significant abnormal laboratory value of the central laboratory (Japan) (routine hematology, blood biochemistry).\n* Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of both ovaries, thus excluding subjects with only one ovary.\n* Contra-indications for the use of gonadotropins i.e.,\n\n * tumors of ovary, breast, uterus, pituitary or hypothalamus.\n * pregnancy or lactation.\n * undiagnosed vaginal bleeding.\n * hypersensitivity to any of the substances in recFSH (FSH, sucrose, sodium citrate, polysorbate 20 and sodium chloride, L-methionine).\n * ovarian cysts or enlarged ovaries not related to PCOS.\n * malformation of the sexual organs incompatible with pregnancy.\n * fibroid tumors of the uterus incompatible with pregnancy.\n* Use of hormonal preparations within 1 month prior to screening.\n* Hypertension (systolic blood pressure \\>150 mm Hg and/or diastolic blood pressure \\>90 mm Hg) or treated hypertension.\n* Epilepsia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease.\n* Administration of investigational drugs within 3 months prior to screening.'}, 'identificationModule': {'nctId': 'NCT00988260', 'briefTitle': 'Japanese Bridging Trial of Org 37462 (Study P05969)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Phase II Bridging Trial of Org 37462', 'orgStudyIdInfo': {'id': 'P05969'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ganirelix 0.125 mg', 'interventionNames': ['Drug: Ganirelix']}, {'type': 'EXPERIMENTAL', 'label': 'Ganirelix 0.25 mg', 'interventionNames': ['Drug: Ganirelix']}, {'type': 'EXPERIMENTAL', 'label': 'Ganirelix 0.5 mg', 'interventionNames': ['Drug: Ganirelix']}], 'interventions': [{'name': 'Ganirelix', 'type': 'DRUG', 'otherNames': ['Org 37462', 'SCH 900761', 'Orgalutran', 'Ganirelix Acetate', 'Ganirest'], 'description': 'Ganirelix 0.125 mg subcutaneous daily (SC OD) for up to 14 days', 'armGroupLabels': ['Ganirelix 0.125 mg']}, {'name': 'Ganirelix', 'type': 'DRUG', 'otherNames': ['Org 37462', 'SCH 900761', 'Orgalutran', 'Ganirelix Acetate', 'Ganirest'], 'description': 'Ganirelix 0.25 mg subcutaneous daily (SC OD) for up to 14 days', 'armGroupLabels': ['Ganirelix 0.25 mg']}, {'name': 'Ganirelix', 'type': 'DRUG', 'otherNames': ['Org 37462', 'SCH 900761', 'Orgalutran', 'Ganirelix Acetate', 'Ganirest'], 'description': 'Ganirelix 0.5 mg subcutaneous daily (SC OD) for up to 14 days', 'armGroupLabels': ['Ganirelix 0.5 mg']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}