Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Study Description

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Brief Summary:

ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.

Condition or disease	Intervention/treatment	Phase
Secondary Hypogonadism	Drug: Androxal	Phase 3

Detailed Description:

This study is a phase III, open label safety study with a six month active dosing period. All subjects will be started at 12.5 mg Androxal and titrated to 25 mg if needed. Safety will be assessed by physical and visual acuity exams, slit lamp eye exams, clinical laboratory tests and adverse event reporting.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	499 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Study Start Date :	May 2012
Actual Primary Completion Date :	October 2013
Actual Study Completion Date :	October 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Androxal 12.5 mg; Androxal 12.5 mg daily	Drug: Androxal; Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated; Other Name: Enclomiphene citrate
Experimental: Androxal 25 mg; Androxal 25 mg daily	Drug: Androxal; Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated; Other Name: Enclomiphene citrate

Outcome Measures

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Primary Outcome Measures :

1. Change From Baseline in Total Morning Testosterone at 26 Weeks [ Time Frame: 6 months ]
   Changes in values from baseline of total morning testosterone levels at Week 26
2. Change From Baseline in LH [ Time Frame: 6 months ]
   Mean change from baseline in LH at end of treatment (26 weeks)
3. Absolute Values of Morning Testosterone [ Time Frame: 6 months ]
   Absolute values of morning testosterone at end of treatment (26 weeks)
4. Mean Change From Baseline FPG [ Time Frame: 6 months ]
   Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)
5. Change From Baseline in BMI [ Time Frame: 6 months ]
   Mean change from baseline in BMI at end of treatment (26 weeks)
6. Change From Baseline in FSH [ Time Frame: 6 months ]
   Change from baseline in FSH at end of treatment (26 weeks)

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Secondary hypogonadal males between the ages of 18 and 65
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:

1. Use of an injectable pelleted testosterone within 6 months prior to study (men currently on topical testosterone products may be enrolled in the study after a 7-day washout period).
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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arizona
Clinical Research Advantage
Glendale, Arizona, United States, 85306
Clinical Research Advantage
Phoenix, Arizona, United States, 85020
United States, Arkansas
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
United States, California
Catalina Research Institute
Chino, California, United States, 91710
SC Clinical Research
Garden Grove, California, United States, 92844
South Orange County Endocrinology
Laguna Hills, California, United States, 92653
Anthony Mills, MD
Los Angeles, California, United States, 90069
SD Uro-Research
San Diego, California, United States, 92103
San Diego Sexual Medicine
San Diego, California, United States, 92120
SC Clinical Research
Santa Ana, California, United States, 92703
West Coast Clinical Research
Tarzana, California, United States, 91356
United States, Colorado
Clinical Research Advantage
Colorado Springs, Colorado, United States, 80906
Clinical Research Advantage
Colorado Springs, Colorado, United States, 80922
United States, Florida
Meridien Research
Bradenton, Florida, United States, 34208
Florida Fertility Institute
Clearwater, Florida, United States, 33759
Therafirst Medical Center
Fort Lauderdale, Florida, United States, 33308
East Coast Institute for Clinical Research
Jacksonville, Florida, United States, 32204
East Coast Institute for Research
Jacksonville, Florida, United States, 32204
East Coast Institute for Research
Jacksonville, Florida, United States, 32258
Cetero Research
Miami Gardens, Florida, United States, 33169
Well Pharma Medical Research
Miami, Florida, United States, 33143
DMI Research
Pinellas Park, Florida, United States, 33782
Ebon Bourne, MD
Plantation, Florida, United States, 33324
Meridien Research
St. Petersburg, Florida, United States, 33709
United States, Maryland
IRC Clinics
Towson, Maryland, United States, 21204
United States, New Jersey
Premier Urology Associates
Lawrenceville, New Jersey, United States, 08648
United States, Texas
Advances in Health
Houston, Texas, United States, 77030
Breco Research
Sugar Land, Texas, United States, 77479
Center of Reproductive Medicine
Webster, Texas, United States, 77598
United States, Utah
Lone Peak Family Medicine
Draper, Utah, United States, 84020
Granger Medical Clin ic
Riverton, Utah, United States, 84065

Sponsors and Collaborators

Repros Therapeutics Inc.

Investigators

Study Chair:	Joseph S Podolski	Repros Therapeutics Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Sponsor home page 

Responsible Party:	Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT01534208 History of Changes
Other Study ID Numbers:	ZA-300
First Posted:	February 16, 2012
Results First Posted:	July 24, 2014
Last Update Posted:	July 24, 2014
Last Verified:	June 2014

Additional relevant MeSH terms:

Neoplasm Metastasis; Hypogonadism; Neoplastic Processes; Neoplasms; Pathologic Processes; Gonadal Disorders; Endocrine System Diseases; Citric Acid; Enclomiphene; Clomiphene; Zuclomiphene; Anticoagulants; Calcium Chelating Agents	Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Fertility Agents, Female; Fertility Agents; Reproductive Control Agents; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators