Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-27 @ 9:17 PM
Study NCT ID:
NCT00920361
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2009-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C571802', 'term': 'follitropin beta'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1664}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-02', 'studyFirstSubmitDate': '2009-06-12', 'studyFirstSubmitQcDate': '2009-06-12', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of retrieved oocytes', 'timeFrame': '2 months, from initiation of treatment to confirmation of pregnancy.'}], 'secondaryOutcomes': [{'measure': 'Pregnancy outcome', 'timeFrame': '2 months, from initiation of treatment to confirmation of pregnancy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fertilization in Vitro']}, 'descriptionModule': {'briefSummary': 'To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method.\n\nPost-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Japanese 1100 patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent IVF\n\nExclusion Criteria:\n\n* Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus\n* Pregnant or possible pregnant women, or lactating women\n* Patients with undiagnosed atypical vaginal bleeding\n* Patients with a history of hypersensitivity to any of the ingredients of this product.\n* Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease'}, 'identificationModule': {'nctId': 'NCT00920361', 'briefTitle': 'Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Designated Drug Use Investigation 1 of Follistim Injection', 'orgStudyIdInfo': {'id': 'P06130'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients who underwent IVF', 'interventionNames': ['Drug: Follitropin beta']}], 'interventions': [{'name': 'Follitropin beta', 'type': 'DRUG', 'description': 'Normally, Follistim Injection 150 or 225 IU will be administered (s.c. or i.m.) once a day for 4 days as follitropin beta (genetical recombination). The dosage will be adapted to growth of follicles (75-375 IU for 6-12 days, in general). If more than 3 follicles of mean diameter 16-20 mm are confirmed by ultrasound tomography, ovulation will be stimulated by using Human Chorionic Gonadotropin (hCG) drugs.', 'armGroupLabels': ['1']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}