Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT06188767
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2023-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testosterone-induced Muscle Memory and Underlying Mechanisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C010792', 'term': 'testosterone undecanoate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fiber cross-sectional area', 'timeFrame': 'The change in fiber cross-sectional is assessed at baseline, 4, 20 and 24 weeks', 'description': 'Immunohistochemistry to determine fiber cross-sectional area'}, {'measure': 'Myonuclei', 'timeFrame': 'The change in myonuclei is assessed at baseline, 4, 20 and 24 weeks', 'description': 'Immunohistochemistry to determine number of myonuclei'}, {'measure': 'Skeletal muscle proteome', 'timeFrame': 'The change in the muscle proteome is assessed at baseline, 4, 20 and 24 weeks', 'description': 'Pathway enrichment analysis of the muscle proteome using mass spectrometry-based proteomics'}], 'secondaryOutcomes': [{'measure': 'Lean mass', 'timeFrame': 'The change in lean mass is assessed at baseline, 4, 20 and 24 weeks', 'description': 'Lean mass assessed by dual X-ray absorptiometry (DXA)'}, {'measure': 'Satellite cells', 'timeFrame': 'The change in satellite cells is assessed at baseline, 4, 20 and 24 weeks', 'description': 'Immunohistochemistry to determine number of satellite cells'}, {'measure': 'Muscle strength', 'timeFrame': 'The change in 1-repetition maximum is assessed at baseline, 4, 20 and 24 weeks', 'description': '1-repetition maximum'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skeletal Muscle Physiology']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to investigate underlying mechanisms of testosterone- and resistance training-induced muscle hypertrophy and muscle memory in humans.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* BMI of \\<26 and normal ECG and blood pressure\n\nExclusion Criteria:\n\n* Smoking\n* Chronic disease,\n* Use of prescription medication\n* Pain due to current or previous musculoskeletal injury\n* Resistance training more than once per week in the 12 months leading up to the intervention\n* Current or previous use of prohibited anabolic substances'}, 'identificationModule': {'nctId': 'NCT06188767', 'briefTitle': 'Testosterone-induced Muscle Memory and Underlying Mechanisms', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Long-term Effects of Anabolic Androgenic Steroids on Muscle Growth Potential: Testosterone-induced Muscle Memory and Underlying Mechanisms', 'orgStudyIdInfo': {'id': 'TESTO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Testosterone', 'description': 'Participants are randomized to a single injection of 1000 mg testosterone undecanoate', 'interventionNames': ['Drug: Testosterone Undecanoate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants are randomized to a single placebo injection', 'interventionNames': ['Drug: Testosterone Undecanoate']}], 'interventions': [{'name': 'Testosterone Undecanoate', 'type': 'DRUG', 'description': 'Following testosterone/placebo injection, participants undergo supervised resistance training for 4 weeks. This period is followed by a washout period with no drug and either continued resistance training or detraining for 16 weeks. Thereafter, another 4-week period with supervised resistance training is commenced, with no drug.', 'armGroupLabels': ['Placebo', 'Testosterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lukas Moesgaard, MSc', 'role': 'CONTACT', 'email': 'lm@nexs.ku.dk', 'phone': '+4561724440'}], 'facility': 'The August Krogh Section for Human and Molecular Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Lukas Moesgaard', 'role': 'CONTACT', 'email': 'lm@nexs.ku.dk', 'phone': '+4561724440'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Morten Hostrup, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Morten Hostrup, PhD', 'investigatorAffiliation': 'University of Copenhagen'}}}}