Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-28 @ 10:41 PM
Study NCT ID:
NCT00920634
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2009-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000858', 'term': 'Anovulation'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571802', 'term': 'follitropin beta'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 384}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, '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': 'Occurrence of ovulation', 'timeFrame': '3 months, from initiation of treatment to confirmation of pregnancy.'}], 'secondaryOutcomes': [{'measure': 'Pregnancy outcome', 'timeFrame': '3 months, from initiation of treatment to confirmation of pregnancy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anovulation']}, 'descriptionModule': {'briefSummary': 'The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction.\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 300 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': 'NCT00920634', 'briefTitle': 'Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Protocol for Drug Use Investigation of Follistim Injection', 'orgStudyIdInfo': {'id': 'P06132'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction (amenorrhea first grade, anovulatory cycle, polycystic ovary syndrome, oligoamenorrhea) who underwent ovulation induction', 'interventionNames': ['Drug: Follitropin beta']}], 'interventions': [{'name': 'Follitropin beta', 'type': 'DRUG', 'description': 'For subcutaneous or intramuscular injection, the usual dosage is 50 IU of follitropin beta (recombinant) once daily for 7 days. The dosage should be adjusted subsequently while monitoring the development of follicles (dose increase by 25 IU every 7 days if the response of the ovaries is poor) and, after confirming presence of follicles of 18 mm or larger in mean diameter by the ultrasonic tomography, ovulation is induced by the administration of a human chorionic gonadotropin preparation.', 'armGroupLabels': ['1']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}