Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism

Completed · Phase 3 · Has a placebo group

Conditions studied: Secondary Hypogonadism

In brief

The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T\<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not have previously been treated with testosterone products within the last 6 months.

Key facts

Study ID: NCT01532414
Run by: Repros Therapeutics Inc.
People needed: 151
Starts: 2012-08-01
Expected to finish: 2013-03-01
Last updated by the study team: 2015-05-27

Who can join

Age: 18 and older, up to 60. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Overweight (BMI 25 to 42 kg/m2 inclusive) males age 18 to 60 inclusive
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 characterized as having 2 consecutive morning testosterone assessments < 300ng/dL, one of which must be confirmed at Baseline.
LH < 9.4 mIU/mL (at Visit 1 only)
Sperm count ≥ 15 million per milliliter (assessed twice at least 48 hours apart)
Ability to complete the study in compliance with the protocol
Ability to understand and provide written informed consent
Agreement to provide a total of up to 6 semen sample in a sponsor-approved clinic on up to 6 separate occasions.

You may not qualify if…

Any prior use of testosterone treatments within the last 6 months
Use of 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 or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
Clinically significant abnormal findings at Screening (Visit 1) or Baseline, based on the Investigator's assessment
A hematocrit >54% or a hemoglobin >17 g/dL (sponsor may approve enrollment of subjects with hemoglobin up to 17.5 g/dL if the subject is at a location with a high elevation)
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)
Abnormal fundoscopy exam such as central retinal vein occlusion
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, vasectomy, 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 such as glucocorticoids
History of drug abuse or chronic narcotic use including methadone
A recent history of alcoholism or illegal substance or steroid abuse (<2 years) or presence of moderate alcohol use (>21 drinks per week)
Subjects with known history of HIV and/or Hepatitis C
Subjects with end stage renal disease
History of liver disease (including malignancy) or a confirmed AST or ALT >3 times the upper limit of normal
History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia or know history of QTc interval prolongation
History of cerebrovascular disease
History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism)
History of erythrocytosis or polycythemia

Where it is running

Coastal Clinical Research — Mobile, Alabama, United States
Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
SC Clinical Research — Garden Grove, California, United States
Mission Internal Medicine Group — Mission Viejo, California, United States
Rancho Cucamonga Clinical Trials — Rancho Cucamonga, California, United States
San Diego Sexual Medicine — San Diego, California, United States
West Coast Clinical Research — Tarzana, California, United States
Florida Fertility Institute — Clearwater, Florida, United States
Tampa Bay Medical Research — Clearwater, Florida, United States
ALL Medical Research — Cooper City, Florida, United States
Clinical Research of South Florida — Coral Gables, Florida, United States
Therafirst Medical Center — Fort Lauderdale, Florida, United States
Well Pharma Medical Research Group — Miami, Florida, United States
Phase One Solutions — Miami Gardens, Florida, United States
Meridien Research — St. Petersburg, Florida, United States
Central Kentucky Research Associates — Lexington, Kentucky, United States
Clinical Research Advantage — Henderson, Nevada, United States
Premier Urology Associates — Lawrenceville, New Jersey, United States
Rochester Clinical Research — Rochester, New York, United States
Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
New Orleans Center for Clinical Research — Knoxville, Tennessee, United States
Lone Peak Family Medicine — Draper, Utah, United States
Granger Medical Clinic — West Valley City, Utah, United States

Full record on ClinicalTrials.gov

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