Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT04975334
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2021-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Antagonism in Hypogonadotropic Hypogonadism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009270', 'term': 'Naloxone'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average change in mean Luteinizing Hormone (LH) value', 'timeFrame': 'Before and after treatment', 'description': 'Change in mean LH before vs. after naloxone bolus'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypogonadotropic Hypogonadism', 'naloxone'], 'conditions': ['Hypogonadotropic Hypogonadism', 'Low Testosterone']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with hypogonadotropic hypogonadism (HH).', 'detailedDescription': 'Assignment: Each study subject will serve as their own control.\n\nDelivery of Interventions:\n\n* Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.\n* During the study, the subjects will undergo the following:\n\n * Undergo q10 min blood sampling for 3 hours\n * Receive a naloxone bolus at the midpoint of q10 min sampling'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion\n\n* Male\n* Age 18-75 years\n* Confirmed diagnosis of hypogonadotropic hypogonadism (low testosterone)\n* All medical conditions stable\n* Normal blood pressure (systolic BP \\< 140 mm Hg, diastolic \\< 90 mm Hg)\n* Negative urine drug screening panel\n* Hemoglobin\n* Men on adequate testosterone replacement therapy: normal male reference range\n* Men off testosterone replacement therapy: no lower than 0.5 gm/dL below the lower limit of the reference range for normal women\n\nExclusion\n\n* Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol\n* Current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis and, if applicable, unwilling to complete an appropriate washout for that particular medication and its method of administration\n* Current or recent use of a medication that affects the opioid pathway\n* Active illicit drug use'}, 'identificationModule': {'nctId': 'NCT04975334', 'briefTitle': 'Opioid Antagonism in Hypogonadotropic Hypogonadism', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Opioid Antagonism in Hypogonadotropic Hypogonadism', 'orgStudyIdInfo': {'id': '313510'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'naloxone', 'description': 'one period of frequent blood sampling with IV administration of naloxone (one bolus)', 'interventionNames': ['Drug: Naloxone']}], 'interventions': [{'name': 'Naloxone', 'type': 'DRUG', 'description': 'One bolus of naloxone', 'armGroupLabels': ['naloxone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Stephanie Seminara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stephanie B. Seminara, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine', 'investigatorFullName': 'Stephanie B. Seminara, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}