Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

Completed · Phase 2 · Has a placebo group

Conditions studied: Secondary Hypogonadism

In brief

The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.

Key facts

Study ID

NCT01270841

Run by

Repros Therapeutics Inc.

People needed

83

Starts

2011-01-01

Expected to finish

2011-12-01

Last updated by the study team

2014-07-28

Who can join

Age: 21 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Healthy males between the ages of 21 and 65 years of age
• 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 morning testosterone <250ng/dL (two assessments at least 10 days apart)
• Ability to complete the study in compliance with the protocol
• Ability to understand and provide written informed consent
• Agreement to use double barrier contraception if with a fertile female partner
• Agreement to provide a semen sample in the clinic

You may not qualify if…

• Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 6 months prior to study
• 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 but exhibiting glycemic control will be allowed into the study
• A hematocrit >50% or a hemoglobin >17 g/dL
• Clinically significant abnormal findings on screening examination
• 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, 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 hyperprolactinemia with or without a tumor
• Chronic use of medications use such as glucocorticoids
• Subjects with cystic fibrosis (mutation of the CFTR gene)
• Subjects unable to provide a semen sample in the clinic
• Subject has a BMI >36 kg/m2

Where it is running

• Paradigm Clinical Inc. — Garden Grove, California, United States
• Northern California Research Corp — Sacramento, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Los Angeles Biomedical Research Institute — Torrance, California, United States
• Affiliated Clinical Research — Las Vegas, Nevada, United States
• Affiliated Clinical Research Inc. — Las Vegas, Nevada, United States
• Weill Cornell Medical College and Smith Institute — Great Neck, New York, United States
• Jed Kaminetsky — New York, New York, United States
• Natan Bar-Chama — New York, New York, United States
• Michael A Werner — Purchase, New York, United States
• Discovery Clinical Trials — Austin, Texas, United States
• Research Across America — Carrollton, Texas, United States
• Texas Urology Specialist — Houston, Texas, United States
• Centex Research — Houston, Texas, United States
• Endocrine and Psychiatry Center — Houston, Texas, United States
• Protenium Clinical Research — Hurst, Texas, United States
• R/D Clinical Research — Lake Jackson, Texas, United States
• Cetero Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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