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

Phase 3

Completed

Conditions: Secondary Hypogonadism

Interventions: Drug: Androxal

Registration Number: NCT01534208

Lead Sponsor: Repros Therapeutics Inc.

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 499

Inclusion Criteria

Secondary hypogonadal males between the ages of 18 and 65
Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1.
All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
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
LH < 15mIU/mL (at Visit 1 only)
Ability to complete the study in compliance with the protocol
Ability to understand and provide written informed consent.

Exclusion Criteria

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).
Use testosterone injection, spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
Use of Clomid in the past year
Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study.
A hematocrit ≥ 51% or a hemoglobin ≥ 17 g/dL
Clinically significant abnormal findings on screening examination, based on the Investigator's assessment.
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.
Known hypersensitivity to Clomid
Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based on 0-4 scale or any trace of posterior subcapsular cataract)
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
Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, or tumors of the pituitary)
Current or history of breast cancer
Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA > 3.6
Presence or history of known hyperprolactinemia with or without a tumor
Chronic use of medications use such as glucocorticoids
Chronic use of narcotics
Subjects know to be positive for HIV
End stage renal disease
Subjects with cystic fibrosis (mutation of the CFTR gene)
Enrollment in a previous Androxal study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Androxal 25 mg	Androxal	Androxal 25 mg daily
Androxal 12.5 mg	Androxal	Androxal 12.5 mg daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in BMI	6 months	Mean change from baseline in BMI at end of treatment (26 weeks)
Change From Baseline in LH	6 months	Mean change from baseline in LH at end of treatment (26 weeks)
Absolute Values of Morning Testosterone	6 months	Absolute values of morning testosterone at end of treatment (26 weeks)
Mean Change From Baseline FPG	6 months	Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)
Change From Baseline in Total Morning Testosterone at 26 Weeks	6 months	Changes in values from baseline of total morning testosterone levels at Week 26
Change From Baseline in FSH	6 months	Change from baseline in FSH at end of treatment (26 weeks)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (25): IRC Clinics
🇺🇸
Towson, Maryland, United States
Meridien Research
🇺🇸
St. Petersburg, Florida, United States
Breco Research
🇺🇸
Sugar Land, Texas, United States
South Orange County Endocrinology
🇺🇸
Laguna Hills, California, United States
Ebon Bourne, MD
🇺🇸
Plantation, Florida, United States
Advances in Health
🇺🇸
Houston, Texas, United States
Lone Peak Family Medicine
🇺🇸
Draper, Utah, United States
East Coast Institute for Research
🇺🇸
Jacksonville, Florida, United States
DMI Research
🇺🇸
Pinellas Park, Florida, United States
East Coast Institute for Clinical Research
🇺🇸
Jacksonville, Florida, United States
SD Uro-Research
🇺🇸
San Diego, California, United States
Anthony Mills, MD
🇺🇸
Los Angeles, California, United States
Florida Fertility Institute
🇺🇸
Clearwater, Florida, United States
San Diego Sexual Medicine
🇺🇸
San Diego, California, United States
Well Pharma Medical Research
🇺🇸
Miami, Florida, United States
Premier Urology Associates
🇺🇸
Lawrenceville, New Jersey, United States
Granger Medical Clin ic
🇺🇸
Riverton, Utah, United States
Center of Reproductive Medicine
🇺🇸
Webster, Texas, United States
Baptist Health Center for Clinical Research
🇺🇸
Little Rock, Arkansas, United States
Clinical Research Advantage
🇺🇸
Colorado Springs, Colorado, United States
Therafirst Medical Center
🇺🇸
Fort Lauderdale, Florida, United States
Catalina Research Institute
🇺🇸
Chino, California, United States
Cetero Research
🇺🇸
Miami Gardens, Florida, United States
SC Clinical Research
🇺🇸
Santa Ana, California, United States
West Coast Clinical Research
🇺🇸
Tarzana, California, United States