Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism

Completed · Phase 3 · Has a placebo group

Conditions studied: Effect of Treatment on Bone Mineral Density

In brief

To determine the effects of 12 months of treatment with Androxal on bone mineral density in men with secondary hypogonadism.

Key facts

Study ID

NCT01619683

Run by

Repros Therapeutics Inc.

People needed

300

Starts

2012-09-01

Expected to finish

2014-09-01

Last updated by the study team

2014-10-01

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, or BMI 23 to 42 inclusive in Asian subjects) males age 18 to 60 inclusive
• 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 <300ng/dL measured twice on separate days. One of the two TT levels must be confirmed at baseline. Subjects who fail this criterion will be enrolled in the placebo group.
• LH <9.4 mIU/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 or pelleted testosterone within 6 months prior to study (men currently on topical products may be enrolled in the study after a 7-day washout period)
• Use of 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 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), based on the Investigator's assessment.
• A hematocrit >54% or a hemoglobin >17 g/dL
• Clinically significant abnormal laboratory findings at baseline (Visit 2), 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)
• 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, or tumors of the pituitary)
• Current or history of breast cancer
• Subjects with a Z-score of <2
• Hyperparathyroidism, metabolic bone disease, previous fracture of the spine, recent chemotherapy, use of medications that may influence BMD (thyroid replacement therapy, immunosuppressive therapy, prednisone or antiepileptic drugs
• No intravenous or oral contrast agents within 7 days.
• Subject weighs >300 pounds (>136 kg)
• 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
• History of drug abuse or chronic narcotic use including methadone
• Subjects with known history of HIV and/or Hepatitis C
• Subjects with end stage renal disease
• Subjects with cystic fibrosis (mutation of the CFTR gene)

Where it is running

• Study site — Clearwater, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Gardens, Florida, United States
• Study site — Henderson, Nevada, United States
• Study site — Lawrenceville, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Mission Viejo, California, United States
• Study site — Newport Beach, California, United States
• Study site — Rancho Cucamonga, California, United States

Full record on ClinicalTrials.gov

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