Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT00290134
Status:
COMPLETED
Last Update Posted:
2008-03-03
First Post:
2006-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-29', 'studyFirstSubmitDate': '2006-02-09', 'studyFirstSubmitQcDate': '2006-02-09', 'lastUpdatePostDateStruct': {'date': '2008-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in morning total testosterone levels from baseline to Week 4 (end of therapy)'}], 'secondaryOutcomes': [{'measure': 'Change in total testosterone levels from baseline to Weeks 2 and 6'}, {'measure': 'Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 2, 4, and 6'}, {'measure': 'Change in SHBG, E2, LH, FSH and inhibin B from baseline to Weeks 2, 4, and 6'}]}, 'conditionsModule': {'keywords': ['Hypogonadism', 'Testosterone'], 'conditions': ['Hypogonadism']}, 'referencesModule': {'references': [{'pmid': '25009850', 'type': 'BACKGROUND', 'citation': 'Institute of Medicine (US) Committee on Assessing the Need for Clinical Trials of Testosterone Replacement Therapy; Liverman CT, Blazer DG, editors. Testosterone and Aging: Clinical Research Directions. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216173/'}, {'pmid': '11158037', 'type': 'BACKGROUND', 'citation': 'Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR; Baltimore Longitudinal Study of Aging. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab. 2001 Feb;86(2):724-31. doi: 10.1210/jcem.86.2.7219.'}, {'pmid': '11836290', 'type': 'BACKGROUND', 'citation': 'Feldman HA, Longcope C, Derby CA, Johannes CB, Araujo AB, Coviello AD, Bremner WJ, McKinlay JB. Age trends in the level of serum testosterone and other hormones in middle-aged men: longitudinal results from the Massachusetts male aging study. J Clin Endocrinol Metab. 2002 Feb;87(2):589-98. doi: 10.1210/jcem.87.2.8201.'}, {'pmid': '15951102', 'type': 'BACKGROUND', 'citation': 'Nieschlag E, Swerdloff R, Behre HM, Gooren LJ, Kaufman JM, Legros JJ, Lunenfeld B, Morley JE, Schulman C, Wang C, Weidner W, Wu FC; International Society of Andrology (ISA); International Society for the Study of the Aging Male (ISSAM); European Association of Urology (EAU). Investigation, treatment and monitoring of late-onset hypogonadism in males. ISA, ISSAM, and EAU recommendations. Eur Urol. 2005 Jul;48(1):1-4. doi: 10.1016/j.eururo.2005.04.027. No abstract available.'}, {'pmid': '12198738', 'type': 'BACKGROUND', 'citation': 'Morales A, Lunenfeld B; International Society for the Study of the Aging Male. Investigation, treatment and monitoring of late-onset hypogonadism in males. Official recommendations of ISSAM. International Society for the Study of the Aging Male. Aging Male. 2002 Jun;5(2):74-86. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether one or more fispemifene dose regimens are more effective than placebo in the treatment of hypogonadism in older men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total testosterone level \\<240 ng/dL\n* Serum LH and FSH levels within normal limits\n\nExclusion Criteria:\n\n* Elevated prolactin\n* Evidence of Benign Prostatic Hypertrophy\n* History of or current breast cancer, prostate cancer, abnormal DRE or elevated PSA or any other malignancy\n* Clinically significant endocrine/metabolic or cardiovascular disease\n* Significant polycythemia'}, 'identificationModule': {'nctId': 'NCT00290134', 'briefTitle': 'A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of Hypogonadism', 'organization': {'class': 'INDUSTRY', 'fullName': 'QuatRx Pharmaceuticals Company'}, 'officialTitle': 'Preliminary Efficacy and Safety of Fispemifene in the Treatment of Hypogonadism: A 4 Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Daily Oral Doses of 100, 200, and 300 mg Fispemifene and Placebo', 'orgStudyIdInfo': {'id': '101-50204'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fispemifene once daily for 4 weeks', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '95350', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '20770', 'city': 'Greenbelt', 'state': 'Maryland', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 39.00455, 'lon': -76.87553}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11530', 'city': 'Garden City', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '14221', 'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}, {'zip': '73008', 'city': 'Bethany', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 35.51867, 'lon': -97.63226}}, {'zip': '29650', 'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98166', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Janne Komi, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hormos Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QuatRx Pharmaceuticals Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hormos Medical', 'class': 'INDUSTRY'}]}}}