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

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ClinicalTrials.gov Identifier: NCT01619683
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : October 1, 2014
Information provided by (Responsible Party):
Repros Therapeutics Inc.

June 12, 2012
June 14, 2012
October 1, 2014
September 2012
September 2014   (Final data collection date for primary outcome measure)
Bone Mineral Density [ Time Frame: 52 weeks ]
Change in bome mineral density at the end of study compared to placebo
Same as current
Complete list of historical versions of study NCT01619683 on ClinicalTrials.gov Archive Site
Testosterone [ Time Frame: 52 weeks ]
Changes of values from baseline in total morning Testosterone levels at week 52.
Same as current
Not Provided
Not Provided
Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism
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
To determine the effects of 12 months of treatment with Androxal on bone mineral density in men with secondary hypogonadism.
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.
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Effect of Treatment on Bone Mineral Density
  • 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
  • Drug: Placebo
    1 placebo capsule per day, oral
  • Experimental: Androxal
    Intervention: Drug: enclomiphene citrate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Repros Therapeutics Inc.
Repros Therapeutics Inc.
Not Provided
Not Provided
Repros Therapeutics Inc.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP