Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT00403793
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2006-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark', 'Finland', 'Germany', 'Italy', 'Netherlands', 'United Kingdom']}, 'interventionBrowseModule': {'meshes': [{'id': 'C044815', 'term': 'etonogestrel'}, {'id': 'C010792', 'term': 'testosterone undecanoate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-02', 'studyFirstSubmitDate': '2006-11-22', 'studyFirstSubmitQcDate': '2006-11-24', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% of men who had a sperm concentration of 1 million/ml or less at week 16.', 'timeFrame': 'Week 16'}], 'secondaryOutcomes': [{'measure': 'Semen Parameters', 'timeFrame': 'At several timepoints during treatment'}, {'measure': 'Reversibility of Suppression', 'timeFrame': 'Post-Treatment'}, {'measure': 'Hormones', 'timeFrame': 'At several timepoints'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'At several timepoints'}, {'measure': 'Safety', 'timeFrame': 'At several timepoints'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '18413423', 'type': 'RESULT', 'citation': 'Mommers E, Kersemaekers WM, Elliesen J, Kepers M, Apter D, Behre HM, Beynon J, Bouloux PM, Costantino A, Gerbershagen HP, Gronlund L, Heger-Mahn D, Huhtaniemi I, Koldewijn EL, Lange C, Lindenberg S, Meriggiola MC, Meuleman E, Mulders PF, Nieschlag E, Perheentupa A, Solomon A, Vaisala L, Wu FC, Zitzmann M. Male hormonal contraception: a double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2008 Jul;93(7):2572-80. doi: 10.1210/jc.2008-0265. Epub 2008 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'Male volunteers receive a new hormonal contraceptive consisting of an implant releasing a hormone and hormone injections in order to investigate the suppressive effect on sperm production and reversibility of sperm production after end of treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Mentally and physically healthy\n* BMI between 18 and 32 kg/m\\^2\n* Two pre-treatment semen samples \\> 20 million/ml with normal morphology and motility\n\nExclusion Criteria:\n\n* History or presence of psychiatric disease, liver disease, renal disease, diabetes, cardiovascular disease, any malignancy, prostatic disease, or genitourinary infection\n* PSA \\> 2.5 ng/ml\n* Use of drugs known to interfere with pharmacokinetics of steroids\n* Use of lipid-lowering drugs'}, 'identificationModule': {'nctId': 'NCT00403793', 'briefTitle': 'Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Phase II -b, Placebo-Controlled Trial Investigating the Efficacy, Safety and Pharmacokinetics of a Subcutaneous Etonogestrel Implant Combined With i.m. Testosterone Undecanoate for Male Contraception', 'orgStudyIdInfo': {'id': 'P06057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'etonogestrel with testosterone undecanoate', 'interventionNames': ['Drug: etonogestrel with testosterone undecanoate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'etonogestrel with testosterone undecanoate', 'type': 'DRUG', 'description': '42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks', 'armGroupLabels': ['Arm 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '42 or 44 weeks with placebo implant and placebo injections', 'armGroupLabels': ['Arm 2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}