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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01619683
First received: June 12, 2012
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Change in bome mineral density at the end of study compared to placebo


Secondary Outcome Measures:
  • Testosterone [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Changes of values from baseline in total morning Testosterone levels at week 52.


Enrollment: 300
Study Start Date: September 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619683

Locations
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, Florida, United States, 33143
Miami Gardens, Florida, United States, 33169
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.
  More Information

Additional Information:
No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01619683     History of Changes
Other Study ID Numbers: ZA-303
Study First Received: June 12, 2012
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypogonadism
Endocrine System Diseases
Gonadal Disorders
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Chelating Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Fertility Agents
Fertility Agents, Female
Hematologic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014