Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT05586802
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2022-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007713', 'term': 'Klinefelter Syndrome'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D058533', 'term': 'Sex Chromosome Disorders of Sex Development'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'C000591245', 'term': 'semaglutide'}, {'id': 'D006063', 'term': 'Chorionic Gonadotropin'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two designs according to the presence of fertility desire (Design 1) or high metabolic risk (Design 2)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-30', 'studyFirstSubmitDate': '2022-10-15', 'studyFirstSubmitQcDate': '2022-10-15', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Design 1 : sperm retrieval rate at mTESE biopsy', 'timeFrame': 'mTESE biopsy 26 weeks after hormonal intervention', 'description': 'Sperm retrieval rate at mTESE biopsy (Group A and B)'}, {'measure': 'Design 2 : change in insulin resistance index (HOMA-IR)', 'timeFrame': 'From baseline to week 26 of intervention', 'description': 'HOMA-IR calculated using fasting glucose and insulin levels'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolic syndrome', 'Infertility', 'Aromatase', 'Testosterone/estradiol ratio', 'mTESE biopsy', 'GLP1 agonists'], 'conditions': ['Klinefelter Syndrome']}, 'descriptionModule': {'briefSummary': 'The study seeks primarily to determine whether modulation of systemic and testicular sex steroids balance by aromatase inhibitors will positively affect the metabolic health and spermatogenesis of men with Klinefelter syndrome (KFS) as compared to the current state of the art for each issue.\n\nSecondary objectives of this study are (i) to unravel the heterogeneity of the reproductive and metabolic phenotype of men with KFS by performing a multi-omic analysis in a large cohort at baseline; (ii) to evaluate the efficacy of semaglutide-induced weight loss to achieve metabolic and reproductive benefit in men with Klinefelter syndrome as compared to standard testosterone replacement; (ii) to assess whether addition of hCG to aromatase inhibitors further increases intratesticular testosterone and promotes spermatogenesis in men with KFS.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Diagnosis of Klinefelter syndrome (47,XXY or mosaicism)\n\nDesign 1:\n\n* Age range: 16-40 years old\n* Intention to become parent or interest in fertility preservation\n* Confirmed azoospermia (lack of spermatozoids) after centrifugation of one semen sample\n\nDesign 2:\n\n* Age range: 18-65 years old\n* No interest in fertility or fertility preservation\n* Hypogonadism at diagnosis or after wash-out of testosterone replacement therapy\n* High metabolic risk defined as overweight (BMI 25-28 kg/m2) and insulin resistance (HOMA-IR \\> 2.6)\n\nExclusion Criteria:\n\n* Contraindications to testosterone-rising therapies (prostate or breast cancer, PSA \\> 4 µg/l, active liver disease, symptomatic heart disease)\n* Decreased life expectancy due to terminal disease\n* Known or suspected non-compliance, drug or alcohol abuse\n* Inability to follow the procedures of the study (language problems, severe psychological or mental disorders)'}, 'identificationModule': {'nctId': 'NCT05586802', 'acronym': 'KLIN-HEALTH', 'briefTitle': 'Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Dissecting the Importance of Sex Steroids Balance for Metabolic and Reproductive Health in Men With Klinefelter Syndrome: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'PZ00P3_202151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group 1 (Fertility) - positive micro-dissection testicular sperm extraction (mTESE) biopsy 1', 'description': 'Men with Klinefelter syndrome seeking fertility or interested in fertility preservation that undergo mTESE biopsy after wash-out of testosterone replacement therapy and have positive sperm retrieval (detectable spermatozoids)'}, {'type': 'EXPERIMENTAL', 'label': 'Group 1 (Fertility) - negative mTESE biopsy 1, then randomized to Arm A', 'description': 'Men with Klinefelter syndrome seeking fertility or interested in fertility preservation that undergo mTESE biopsy after wash-out of testosterone replacement therapy and have negative sperm retrieval (no detectable spermatozoids), subsequently randomized to receive an hormonal stimulation for 26 weeks', 'interventionNames': ['Drug: Anastrozole']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1 (Fertility) - negative mTESE biopsy 1, then randomized to Arm B', 'description': 'Men with Klinefelter syndrome seeking fertility or interested in fertility preservation that undergo mTESE biopsy after wash-out of testosterone replacement therapy and have negative sperm retrieval (no detectable spermatozoids), subsequently randomized to receive an hormonal stimulation for 26 weeks', 'interventionNames': ['Drug: Anastrozole', 'Drug: human chorionic gonadotropin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 (Metabolic Risk) - randomized to Arm C', 'description': 'Men with Klinefelter syndrome not interested in fertility that present with high metabolic risk and consent to a wash-out of testosterone replacement therapy. They are subsequently randomized to receive an hormonal treatment to improve metabolic health. This arm will receive an active comparator by a testosterone gel', 'interventionNames': ['Drug: Testosterone gel']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (Metabolic Risk) - randomized to Arm D', 'description': 'Men with Klinefelter syndrome not interested in fertility that present with high metabolic risk and consent to a wash-out of testosterone replacement therapy. They are subsequently randomized to receive an hormonal treatment to improve metabolic health. This arm will receive an an experimental treatment', 'interventionNames': ['Drug: Anastrozole']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (Metabolic Risk) - randomized to Arm E', 'description': 'Men with Klinefelter syndrome not interested in fertility that present with high metabolic risk and consent to a wash-out of testosterone replacement therapy. They are subsequently randomized to receive an hormonal treatment to improve metabolic health. This arm will receive an an experimental treatment', 'interventionNames': ['Drug: Semaglutide']}], 'interventions': [{'name': 'Anastrozole', 'type': 'DRUG', 'otherNames': ['Anastrozole Teva'], 'description': 'This will be an experimental treatment for 26 weeks in Group 1 Arm A and Arm B as well for Group 2 Arm D', 'armGroupLabels': ['Group 1 (Fertility) - negative mTESE biopsy 1, then randomized to Arm A', 'Group 1 (Fertility) - negative mTESE biopsy 1, then randomized to Arm B', 'Group 2 (Metabolic Risk) - randomized to Arm D']}, {'name': 'Semaglutide', 'type': 'DRUG', 'otherNames': ['Ozempic'], 'description': 'This will be an experimental treatment for 26 weeks in Group 2 Arm E', 'armGroupLabels': ['Group 2 (Metabolic Risk) - randomized to Arm E']}, {'name': 'human chorionic gonadotropin', 'type': 'DRUG', 'otherNames': ['Choriomon'], 'description': 'This will be an experimental treatment for 26 weeks in addition to anastrozole in Group 1 - Arm B', 'armGroupLabels': ['Group 1 (Fertility) - negative mTESE biopsy 1, then randomized to Arm B']}, {'name': 'Testosterone gel', 'type': 'DRUG', 'otherNames': ['Tostran'], 'description': 'This will be an active comparator for 26 weeks in Group 2 - Arm C', 'armGroupLabels': ['Group 2 (Metabolic Risk) - randomized to Arm C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'GEORGIOS PAPADAKIS, PD Dr med', 'role': 'CONTACT', 'email': 'georgios.papadakis@chuv.ch', 'phone': '+ 41795560308'}], 'facility': 'Service of Endocrinology, Diabetes & Metabolism', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'GEORGIOS PAPADAKIS, MD', 'role': 'CONTACT', 'email': 'georgios.papadakis@chuv.ch', 'phone': '+41795560308'}, {'name': 'RIKIATOU FRANCIOLI, MD', 'role': 'CONTACT', 'email': 'Rikiatou.Francioli@chuv.ch', 'phone': '+41795562861'}], 'overallOfficials': [{'name': 'GEORGIOS PAPADAKIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service of endocrinology, diabetes & metabolism, CHUV, Lausanne University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'At study completion', 'ipdSharing': 'YES', 'description': 'Upon reasonable request and data transfer agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgios Papadakis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer (Privat docent & MERclin)', 'investigatorFullName': 'Georgios Papadakis', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}