Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT04648969
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2020-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prolonged Pulsatile Kisspeptin Administration 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': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2020-11-11', 'studyFirstSubmitQcDate': '2020-11-24', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average change in luteinizing hormone (LH) pulse amplitude in response to kisspeptin', 'timeFrame': '52 hours', 'description': 'Change in LH amplitude before, during and after kisspeptin administration'}], 'secondaryOutcomes': [{'measure': 'Average change in LH pulse frequency in response to kisspeptin', 'timeFrame': '52 hours', 'description': 'Change in LH frequency before and after kisspeptin administration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypogonadotropic hypogonadism, kisspeptin'], 'conditions': ['Hypogonadotropic Hypogonadism']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.', 'detailedDescription': '* Assignment: Each study subject will serve as their own control. The order of kisspeptin doses will be randomized within each set/exposure.\n* Delivery of Interventions:\n\n * Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. Subjects will also wear a gonadotropin releasing hormone (GnRH) pump prior to the inpatient study visit.\n * On the day of the inpatient study, the subjects will\n\n * Undergo q10 min blood sampling for 6 hours,\n * Receive kisspeptin intravenous (IV) boluses from hour 6 to hour 44 (20 boluses total),\n * Undergo q10 min blood samplings for another 6 hours,\n * Receive a single GnRH IV bolus at hour 51.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion/exclusion criteria:\n\n* Age 18 years and older,\n* Confirmed diagnosis of HH with\n\n * Low testosterone or estradiol,\n * Low or low-normal gonadotropin levels,\n * Thyroid stimulating hormone (TSH) and prolactin within the reference range,\n * Absence of abnormal pituitary or hypothalamic findings on Magnetic resonance imaging (MRI),\n* All other medical conditions stable and well controlled,\n* No prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) except for medications used to treat the subject's reproductive condition,\n* No history of a medication reaction requiring emergency medical care,\n* No illicit drug use,\n* No excessive alcohol consumption (\\<10 drinks/week),\n* Normal blood pressure (BP), (systolic BP \\< 140 mm Hg, diastolic \\< 90 mm Hg),\n* White blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of the upper limit of the reference range,\n* Prolactin below 110% of the upper limit of the reference range,\n* Hemoglobin\n\n * Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women,\n * Men: on adequate testosterone replacement therapy: normal male reference range,\n* Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT) not elevated,\n* For women,\n\n * Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration),\n * Not breastfeeding and not pregnant."}, 'identificationModule': {'nctId': 'NCT04648969', 'briefTitle': 'Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism', 'orgStudyIdInfo': {'id': '313509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: kisspeptin, GnRH', 'description': '• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.', 'interventionNames': ['Drug: kisspeptin 112-121', 'Drug: GnRH']}], 'interventions': [{'name': 'kisspeptin 112-121', 'type': 'DRUG', 'otherNames': ['metastin 45-54'], 'description': '20 intravenous doses of kisspeptin 112-121 (4 different doses of kisspeptin (randomized) in 5 sets)', 'armGroupLabels': ['Experimental: kisspeptin, GnRH']}, {'name': 'GnRH', 'type': 'DRUG', 'otherNames': ['gonadotropin-releasing hormone'], 'description': '1 intravenous dose of GnRH', 'armGroupLabels': ['Experimental: kisspeptin, GnRH']}]}, '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', '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; Massachusetts General Hospital; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine', 'investigatorFullName': 'Stephanie B. Seminara, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}