Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-27 @ 10:39 PM
Study NCT ID:
NCT01904734
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2013-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clomid in Men With Low Testosterone With and Without Prior Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005058', 'term': 'Eunuchism'}, {'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002996', 'term': 'Clomiphene'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2013-07-15', 'studyFirstSubmitQcDate': '2013-07-17', 'lastUpdatePostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total serum testosterone', 'timeFrame': 'at the end of 8 weeks of treatment', 'description': 'laboratory measurement by standard immunometric method'}], 'secondaryOutcomes': [{'measure': 'Bioavailable testosterone', 'timeFrame': 'at the end of 8 weeks of treatment', 'description': 'Non-SHBG bound testosterone by ammonium sulfate precipitation method'}, {'measure': 'Serum sex hormone binding globulin (SHBG)level', 'timeFrame': 'at the end of 8 weeks of treatment', 'description': 'Laboratory measurement of SHBG by standard immunometric technique'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['testosterone', 'hypogonadism', 'pituitary'], 'conditions': ['Hypogonadism, Male']}, 'referencesModule': {'references': [{'pmid': '22458540', 'type': 'BACKGROUND', 'citation': 'Moskovic DJ, Katz DJ, Akhavan A, Park K, Mulhall JP. Clomiphene citrate is safe and effective for long-term management of hypogonadism. BJU Int. 2012 Nov;110(10):1524-8. doi: 10.1111/j.1464-410X.2012.10968.x. Epub 2012 Mar 28.'}, {'pmid': '22044663', 'type': 'BACKGROUND', 'citation': 'Katz DJ, Nabulsi O, Tal R, Mulhall JP. Outcomes of clomiphene citrate treatment in young hypogonadal men. BJU Int. 2012 Aug;110(4):573-8. doi: 10.1111/j.1464-410X.2011.10702.x. Epub 2011 Nov 1.'}, {'pmid': '19694928', 'type': 'BACKGROUND', 'citation': 'Taylor F, Levine L. Clomiphene citrate and testosterone gel replacement therapy for male hypogonadism: efficacy and treatment cost. J Sex Med. 2010 Jan;7(1 Pt 1):269-76. doi: 10.1111/j.1743-6109.2009.01454.x. Epub 2009 Aug 17.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to explore whether men with low testosterone levels, due to altered brain regulation of male hormone function, who have been previously treated with testosterone, respond as well as men who have not been so treated to clomiphene citrate, an agent commonly used for female infertility that has been shown to improve male hormone secretion in some cases.', 'detailedDescription': 'Clomiphene, an oral FDA-approved agent for female infertility has been shown to normalize testosterone levels in men with hypogonadotropic hypogonadism. It appears to be safe and well tolerated. This study will compare testosterone responses to clomiphene citrate in male veterans with hypothalamic hypogonadism naïve to treatment with responses of similar patients already receiving treatment with injectable or transdermal testosterone. This is an open-label, prospective, interventional trial to be conducted in an outpatient specialty care setting. We will randomize 64 hypogonadal male veterans evenly divided between naive and previous treatment and treat for 8 weeks with clomid, increasing the initial dose of 25 mg to 50 mg/day in those who fail to achieve target testosterone level (450 ng/dl) after the first 3 weeks. Endpoint measurements performed in the Phoenix VA Health Care System (PVAHCS) clinical laboratory will be total testosterone as well as bioavailable testosterone and sex hormone binding globulin. Total testosterone level at 8 weeks of treatment will be reported as the primary endpoint. Safety measures (CBC,liver functions, PSA) will be assessed at 8 weeks as well. This study will help serve as a guide for design of future studies of clomiphene in hypogonadal men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient or eligible for care at Phoenix VA Health Care System\n* Male ages 30-70 years\n* testosterone level below 250 ng/dl before treatment\n* able to provide informed written consent\n\nExclusion Criteria:\n\n* evidence of pituitary tumor \\>1mm by MRI or CAT scan\n* chronic illness (renal, cardiac, liver failure)\n* Prostate specific antigen (PSA) \\>4.0 ng/ml\n* history of prostate, breast, or testicular cancer\n* eye disease compromising vision (e.g. cataracts)'}, 'identificationModule': {'nctId': 'NCT01904734', 'briefTitle': 'Clomid in Men With Low Testosterone With and Without Prior Treatment', 'organization': {'class': 'FED', 'fullName': 'Phoenix VA Health Care System'}, 'officialTitle': 'A Comparison of Clomiphene Citrate Responses in Men With Hypothalamic Hypogonadism naïve to, and Previously Treated With, Testosterone', 'orgStudyIdInfo': {'id': 'VETSCLOMIDPHX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'No previous male hormone treatment', 'description': 'Clomiphene', 'interventionNames': ['Drug: Clomiphene']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Previously treated with testosterone', 'description': 'Clomiphene', 'interventionNames': ['Drug: Clomiphene']}], 'interventions': [{'name': 'Clomiphene', 'type': 'DRUG', 'otherNames': ['Clomid', 'Clomiphene citrate'], 'description': 'Start with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks', 'armGroupLabels': ['No previous male hormone treatment', 'Previously treated with testosterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix VA Health Care System', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Sherman M Harman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Phoenix VA Health Care System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phoenix VA Health Care System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Endocrine Division, Dept. of Internal Medicine', 'investigatorFullName': 'Sherman M. Harman', 'investigatorAffiliation': 'Phoenix VA Health Care System'}}}}