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Trial record 34 of 51 for:    "Hypogonadism" | "Estrogens"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01619683
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : October 1, 2014
Information provided by (Responsible Party):
Repros Therapeutics Inc.

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

Condition or disease Intervention/treatment Phase
Effect of Treatment on Bone Mineral Density Drug: enclomiphene citrate Drug: Placebo Phase 3

Detailed Description:
This study is a phase III single-blind placebo-controlled safety study with a 52 week active dosing period with Androxal. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy eye exams, clinical laboratory tests, DEXA scanning, lean soft tissue assessment (LST), and adverse event reporting. Results will be compared to an age-matched placebo group.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: A 12 Month, Single Blind, Placebo Controlled, Phase III Study to Assess the Effects of Enclomiphene Citrate Treatment On Bone Mineral Density in Men With Secondary Hypogonadism
Study Start Date : September 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Androxal Drug: enclomiphene citrate
12.5 mg, 1 capsule, daily, oral. After 6 weeks of treatment, subjects will remain on 12.5 mg/day if their morning testosterone level is greater than 300 ng/dL. If a subject's testosterone is less than 300 ng/dL, the subject's dose will be increased to 25 mg/day
Other Name: Androxal

Placebo Comparator: Placebo Drug: Placebo
1 placebo capsule per day, oral

Primary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: 52 weeks ]
    Change in bome mineral density at the end of study compared to placebo

Secondary Outcome Measures :
  1. Testosterone [ Time Frame: 52 weeks ]
    Changes of values from baseline in total morning Testosterone levels at week 52.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Overweight (BMI 25 to 42 kg/m2 inclusive, or BMI 23 to 42 inclusive in Asian subjects) males age 18 to 60 inclusive
  2. Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1
  3. All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
  4. 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.
  5. LH <9.4 mIU/mL (at Visit 1 only)
  6. Ability to complete the study in compliance with the protocol
  7. Ability to understand and provide written informed consent

Exclusion Criteria:

  1. 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)
  2. Use of testosterone injection, spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
  3. Use of Clomid in the past year
  4. 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
  5. Clinically significant abnormal findings at screening (Visit 1), based on the Investigator's assessment.
  6. A hematocrit >54% or a hemoglobin >17 g/dL
  7. Clinically significant abnormal laboratory findings at baseline (Visit 2), based on the Investigator's assessment
  8. 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.
  9. Known hypersensitivity to Clomid
  10. Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based on 0-4 scale or any trace of posterior subcapsular cataract)
  11. Abnormal fundoscopy exam such as central retinal vein occlusion
  12. 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
  13. Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, or tumors of the pituitary)
  14. Current or history of breast cancer
  15. Subjects with a Z-score of <2
  16. 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
  17. No intravenous or oral contrast agents within 7 days.
  18. Subject weighs >300 pounds (>136 kg)
  19. Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA>3.6
  20. Presence or history of known hyperprolactinemia with or without a tumor
  21. Chronic use of medications use such as glucocorticoids
  22. History of drug abuse or chronic narcotic use including methadone
  23. Subjects with known history of HIV and/or Hepatitis C
  24. Subjects with end stage renal disease
  25. Subjects with cystic fibrosis (mutation of the CFTR gene)
  26. Enrollment in a previous Androxal study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01619683

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United States, Arizona
Mesa, Arizona, United States, 85213
Phoenix, Arizona, United States, 85050
Tempe, Arizona, United States, 85283
United States, California
Mission Viejo, California, United States, 92691
Newport Beach, California, United States, 92663
Rancho Cucamonga, California, United States, 91730
United States, Florida
Clearwater, Florida, United States, 33761
Fort Lauderdale, Florida, United States, 33308
Jupiter, Florida, United States, 33458
Miami Gardens, Florida, United States, 33169
Miami, Florida, United States, 33143
United States, Nevada
Henderson, Nevada, United States, 89052
United States, New Jersey
Lawrenceville, New Jersey, United States, 08690
United States, New York
New York, New York, United States, 10016
Rochester, New York, United States, 14609
United States, Texas
Houston, Texas, United States, 77030
United States, Utah
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Repros Therapeutics Inc.

Additional Information:
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Responsible Party: Repros Therapeutics Inc. Identifier: NCT01619683     History of Changes
Other Study ID Numbers: ZA-303
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Estrogen Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents