Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
NCT ID: NCT01534208
Last Updated: 2014-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
499 participants
INTERVENTIONAL
2012-05-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Androxal 12.5 mg
Androxal 12.5 mg daily
Androxal
Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Androxal 25 mg
Androxal 25 mg daily
Androxal
Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Interventions
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Androxal
Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1.
3. All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
4. Previously or concurrently diagnosed as having secondary hypogonadism and confirmed with morning testosterone level \< 350 ng/dL for men age \< 55 and \< 300ng/dl for men age 55-65
5. LH \< 15mIU/mL (at Visit 1 only)
6. Ability to complete the study in compliance with the protocol
7. Ability to understand and provide written informed consent.
Exclusion Criteria
2. Use testosterone injection, spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
3. Use of Clomid in the past year
4. Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study.
5. A hematocrit ≥ 51% or a hemoglobin ≥ 17 g/dL
6. Clinically significant abnormal findings on screening examination, based on the Investigator's assessment.
7. Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication.
8. Known hypersensitivity to Clomid
9. Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade \> 2 based on 0-4 scale or any trace of posterior subcapsular cataract)
10. Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study
11. Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, or tumors of the pituitary)
12. Current or history of breast cancer
13. Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA \> 3.6
14. Presence or history of known hyperprolactinemia with or without a tumor
15. Chronic use of medications use such as glucocorticoids
16. Chronic use of narcotics
17. Subjects know to be positive for HIV
18. End stage renal disease
19. Subjects with cystic fibrosis (mutation of the CFTR gene)
20. Enrollment in a previous Androxal study
18 Years
65 Years
MALE
No
Sponsors
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Repros Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph S Podolski
Role: STUDY_CHAIR
Repros Therapeutics Inc.
Locations
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Clinical Research Advantage
Glendale, Arizona, United States
Clinical Research Advantage
Phoenix, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Catalina Research Institute
Chino, California, United States
SC Clinical Research
Garden Grove, California, United States
South Orange County Endocrinology
Laguna Hills, California, United States
Anthony Mills, MD
Los Angeles, California, United States
SD Uro-Research
San Diego, California, United States
San Diego Sexual Medicine
San Diego, California, United States
SC Clinical Research
Santa Ana, California, United States
West Coast Clinical Research
Tarzana, California, United States
Clinical Research Advantage
Colorado Springs, Colorado, United States
Clinical Research Advantage
Colorado Springs, Colorado, United States
Meridien Research
Bradenton, Florida, United States
Florida Fertility Institute
Clearwater, Florida, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
East Coast Institute for Clinical Research
Jacksonville, Florida, United States
East Coast Institute for Research
Jacksonville, Florida, United States
East Coast Institute for Research
Jacksonville, Florida, United States
Well Pharma Medical Research
Miami, Florida, United States
Cetero Research
Miami Gardens, Florida, United States
DMI Research
Pinellas Park, Florida, United States
Ebon Bourne, MD
Plantation, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
IRC Clinics
Towson, Maryland, United States
Premier Urology Associates
Lawrenceville, New Jersey, United States
Advances in Health
Houston, Texas, United States
Breco Research
Sugar Land, Texas, United States
Center of Reproductive Medicine
Webster, Texas, United States
Lone Peak Family Medicine
Draper, Utah, United States
Granger Medical Clin ic
Riverton, Utah, United States
Countries
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Related Links
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Sponsor home page
Other Identifiers
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ZA-300
Identifier Type: -
Identifier Source: org_study_id
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