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

Completed · Phase 3

Conditions studied: Secondary Hypogonadism

In brief

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

Key facts

Study ID

NCT01534208

Run by

Repros Therapeutics Inc.

People needed

499

Starts

2012-05-01

Expected to finish

2013-10-01

Last updated by the study team

2014-07-24

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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