Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-01 @ 10:01 AM
Study NCT ID:
NCT00647933
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2008-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C437186', 'term': 'follicle stimulating hormone, human, with HCG C-terminal peptide'}, {'id': 'C002746', 'term': 'Noracycline'}, {'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'D008234', 'term': 'Lynestrenol'}], 'ancestors': [{'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009652', 'term': 'Norpregnenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2000-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-01', 'studyFirstSubmitDate': '2008-03-27', 'studyFirstSubmitQcDate': '2008-03-31', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum number of follicles >= 5 mm (nmax)', 'timeFrame': 'Days 2 - 35'}, {'measure': 'Mean dose-normalized maximum plasma concentration (Cmax) post single dose Org 36286', 'timeFrame': 'Days 1 - 15'}, {'measure': 'Mean dose-normalized area under the curve (AUC) post single dose Org 36286', 'timeFrame': 'Days 1 - 15'}, {'measure': 'Mean total plasma clearance (CL) post single dose Org 36286', 'timeFrame': 'Days 1 - 15'}, {'measure': 'Number of participants with an adverse event (AE)', 'timeFrame': 'Start of treatment up to day 28'}], 'secondaryOutcomes': [{'measure': 'Day on which the number of follicles >= 5 mm was equal to nmax for the first time (dmax)', 'timeFrame': 'Days 2 - 35'}, {'measure': 'Total number of follicles >= 5 mm per day', 'timeFrame': 'Days 2 - 35'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Females', 'Corifollitropin alfa', 'Antibodies', 'Pharmacokinetics', 'Pharmacodynamics'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good physical and mental health;\n* Body Mass Index between 18 and 29 kg/m\\^2;\n* Good venous accessibility;\n\nExclusion Criteria:\n\n* Clinically relevant abnormal blood chemistry, hematology and/or urinalysis at screening;\n* Hypertension (sitting diastolic blood pressure \\> 90 mmHg and/or systolic blood pressure \\> 150 mmHg);\n* Contraindications for the use of oral contraceptives or gonadotropins;\n* PAP-smear (= III) according to the Papanicolaou classification;\n* History of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or any evidence of ovarian dysfunction;\n* Primary ovarian failure;\n* Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease;\n* Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation;\n* Ovarian surgery;\n* Smoking more than 10 cigarettes or equivalents a day;\n* History (within 12 months) of alcohol or drugs abuse;\n* Blood donation (\\> 200 ml) within 90 days prior to screening;\n* Administration of investigational drugs within 90 days prior to start Org 36286.'}, 'identificationModule': {'nctId': 'NCT00647933', 'briefTitle': 'An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 After a Single Subcutaneous Dose in Healthy Female Volunteers Whose Pituitary Function is Suppressed by Lyndiol®.', 'orgStudyIdInfo': {'id': 'P07004'}, 'secondaryIdInfos': [{'id': '38802'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Org 36286 15 μg + Lyndiol®', 'description': 'After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 15 μg.', 'interventionNames': ['Drug: Org 36286', 'Drug: Lyndiol®']}, {'type': 'EXPERIMENTAL', 'label': 'Org 36286 30 μg + Lyndiol®', 'description': 'After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 30 μg.', 'interventionNames': ['Drug: Org 36286', 'Drug: Lyndiol®']}, {'type': 'EXPERIMENTAL', 'label': 'Org 36286 60 μg + Lyndiol®', 'description': 'After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 60 μg.', 'interventionNames': ['Drug: Org 36286', 'Drug: Lyndiol®']}, {'type': 'EXPERIMENTAL', 'label': 'Org 36286 120 μg + Lyndiol®', 'description': 'After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 120 μg.', 'interventionNames': ['Drug: Org 36286', 'Drug: Lyndiol®']}], 'interventions': [{'name': 'Org 36286', 'type': 'DRUG', 'otherNames': ['Corifollitropin alfa'], 'description': 'Subcutaneous Org 36286', 'armGroupLabels': ['Org 36286 120 μg + Lyndiol®', 'Org 36286 15 μg + Lyndiol®', 'Org 36286 30 μg + Lyndiol®', 'Org 36286 60 μg + Lyndiol®']}, {'name': 'Lyndiol®', 'type': 'DRUG', 'otherNames': ['50 μg ethinylestradiol + 2.5 mg lynestrenol'], 'description': 'Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.', 'armGroupLabels': ['Org 36286 120 μg + Lyndiol®', 'Org 36286 15 μg + Lyndiol®', 'Org 36286 30 μg + Lyndiol®', 'Org 36286 60 μg + Lyndiol®']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}