Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2026-01-17 @ 9:37 PM
Study NCT ID:
NCT02667561
Status:
WITHDRAWN
Last Update Posted:
2018-06-06
First Post:
2016-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study has been cancelled and it has not been initiated.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-04', 'studyFirstSubmitDate': '2016-01-26', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics, area under the curve (AUC)', 'timeFrame': '28 days'}, {'measure': 'Pharmacokinetics, maximum concentration (Cmax)', 'timeFrame': '28 days'}, {'measure': 'Pharmacokinetics, time to maximum concentration (Tmax)', 'timeFrame': '28 days'}, {'measure': 'Pharmacokinetics, half-life (t1/2)', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamics, response rate, by Female Sexual Function Index', 'timeFrame': '28 days'}, {'measure': 'Safety, number of adverse events', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-menopausal Period']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Testosterone gel 1% for topic usage in post-menopausal women, for 28 days', 'detailedDescription': 'This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Testosterone gel 1% for topic usage in post-menopausal women, Study participants will receive investigational product for 28 consecutive days, once daily, as per the following allocation: 2.2 mg, 4.4 mg. 8.8 mg or placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '42 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female subjects aged ≥ 42 years and ≤ 65 years, in post-menopausal period for at least 1 year and with active sexual life;\n* Serum testosterone levels \\< 33 ng/mL;\n* Follicle-stimulating hormone (FSH) levels \\> 22 mU/mL;\n* Absence of other significant diseases which, at the physician's discretion, could impact subject's participation in the trial, according to protocol requirements, and study evaluations: medical history, blood pressure and heart rate measurements, physical examination and complimentary laboratory tests;\n* Ability to understand the nature and objective of the trial, including risks and adverse events, which shall be confirmed by Informed Consent Form signature.\n\nExclusion Criteria:\n\n* Screening laboratory tests results presenting clinically relevant deviations that, at the investigator discretion, prevent the subject to participate in the trial due to possible risks;\n* Drugs addiction, including alcohol;\n* Treatment with any drugs known to have a well-established toxic potential to major organs, within 3 months before the trial, ;\n* Participation in any other experimental research or administration of any experimental drug within six months before the initiation of this trial;\n* Pregnancy, labor or miscarriage in the last 12 weeks before the antecipated date of the study treatment start;\n* Any conditions, according to investigator's best judgement, that prevents the subject to participate in the trial."}, 'identificationModule': {'nctId': 'NCT02667561', 'briefTitle': 'Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biolab Sanus Farmaceutica'}, 'officialTitle': 'Phase I Clinical Trial for Evaluation of Pharmacokinetics, Pharmacodynamics and Safety of Testosterone Gel 1% for Topical Use, After Administration of Three Different Doses (2.2 mg, 4.4 mg, 8.8 mg and Placebo) for 28 Consecutive Days in Post-menopausal Women.', 'orgStudyIdInfo': {'id': 'GDN 060/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Testosterone gel 1% 2.2 mg', 'description': 'Testosterone gel 1% Topical use 2.2 mg (220 mg of gel) once daily duration of treatment: 28 days', 'interventionNames': ['Drug: Testosterone gel 1% 2.2 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Testosterone gel 1% 4.4 mg', 'description': 'Testosterone gel 1% Topical use 4.4 mg (440 mg of gel) once daily duration of treatment: 28 days', 'interventionNames': ['Drug: Testosterone gel 1% 4.4 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Testosterone gel 1% 8.8 mg', 'description': 'Testosterone gel 1% Topical use 8.8 mg (880 mg of gel) once daily duration of treatment: 28 days', 'interventionNames': ['Drug: Testosterone gel 1% 8.8 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of Testosterone Gel 1%', 'description': 'Placebo of Testosterone Gel 1% Topical use Approximately 550 mg of gel Once daily duration of treatment: 28 days', 'interventionNames': ['Drug: Placebo of Testosterone Gel 1%']}], 'interventions': [{'name': 'Testosterone gel 1% 2.2 mg', 'type': 'DRUG', 'description': 'Application of 220 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.', 'armGroupLabels': ['Testosterone gel 1% 2.2 mg']}, {'name': 'Testosterone gel 1% 4.4 mg', 'type': 'DRUG', 'description': 'Application of 440 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.', 'armGroupLabels': ['Testosterone gel 1% 4.4 mg']}, {'name': 'Testosterone gel 1% 8.8 mg', 'type': 'DRUG', 'description': 'Application of 880 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.', 'armGroupLabels': ['Testosterone gel 1% 8.8 mg']}, {'name': 'Placebo of Testosterone Gel 1%', 'type': 'DRUG', 'description': 'Application of approximately 550 mg of Placebo of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.', 'armGroupLabels': ['Placebo of Testosterone Gel 1%']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gilberto De Nucci, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Galeno Desenvolvimento de Pesquisas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biolab Sanus Farmaceutica', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}