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Trial record 10 of 19 for:    "Hypogonadism" | "Calcium, Dietary"

Phase III Study to Evaluate Morning Testosterone Normalization in Overweight 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.
 
ClinicalTrials.gov Identifier: NCT01739595
Recruitment Status : Completed
First Posted : December 3, 2012
Results First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE November 29, 2012
First Posted Date  ICMJE December 3, 2012
Results First Submitted Date  ICMJE June 26, 2014
Results First Posted Date  ICMJE May 27, 2015
Last Update Posted Date May 27, 2015
Study Start Date  ICMJE November 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Subjects With Testosterone in Normal Range After Treatment [ Time Frame: 3 months ]
    Proportion (percent) of subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg was calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing. If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the coprimary endpoint based on the Cavg for testosterone would have been achieved. FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment was not calculated.
  • Change in Sperm Concentration [ Time Frame: 3 months ]
    Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo. The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations.
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
  • Change in morning testosterone [ Time Frame: 3 months ]
    Proportion of subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg will be calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 8, 12, 16 and 24 hours after dosing.
  • Change in Sperm Concentration [ Time Frame: 3 months ]
    Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment
Change History Complete list of historical versions of study NCT01739595 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism
Official Title  ICMJE A Randomized, Double Blind, Placebo Controlled Multi-Center Phase III Study to Evaluate Normalization of Morning Testosterone Levels in Overweight Men With Acquired Hypogonadotropic Hypogonadism and Normal Sperm Concentration
Brief Summary The purpose of ZA-302 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not have previously been treated with testosterone products within the last 6 months.
Detailed Description

Protocol ZA-302 is a randomized, double-blind, placebo-controlled multi-center Phase 3 study to evaluate normalization of morning testosterone levels in overweight men with acquired hypogonadotropic hypogonadism and normal baseline sperm concentrations. The study requires 10 to 12 clinic visits (2 for eye exams), and is approximately 4 to 5½ months in duration. Subjects will be treated for 12-18 weeks. At Visit 3 (Week 6) subjects who do not achieve morning T values ≥300 ng/dL will be up-titrated to 25 mg. Placebo subjects may be sham titrated. Up-titrated subjects will receive an additional 6 weeks of treatment (18 weeks total). A schedule of procedures and assessments is displayed in Section 4. The study will enroll up to 152 male subjects, up to 114 randomized to treatment with Androxal and up to 38 randomized to placebo, in a 3:1 ratio. Subjects must not have used any prior testosterone treatments within the last 6 months.

Eligible subjects must have 2 consecutive assessments of morning T below 300 ng/dL and LH below 9.4 mIU/mL. They will provide 2 sperm samples at baseline, at least 2 days apart, another 2 after 12 weeks of treatment, and up-titrated subjects will provide an additional 2 samples at the end of treatment. After 12 weeks of treatment (V5) all subjects will undergo serial T assessment for determination of the Cavg. Safety assessments will include collection of adverse events, eye examinations, physical examinations and clinical laboratory assessments.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Secondary Hypogonadism
Intervention  ICMJE
  • Drug: enclomiphene citrate
    oral, capsules, taken one time daily, for 3 months
    Other Name: Androxal
  • Drug: Placebo
    Oral capsule taken one time daily for 3 months
    Other Name: Dummy
Study Arms  ICMJE
  • Experimental: Androxal 12.5 mg
    Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily
    Intervention: Drug: enclomiphene citrate
  • Experimental: Androxal 25 mg
    Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily
    Intervention: Drug: enclomiphene citrate
  • Placebo Comparator: Placebo
    Placebo oral capsules taken one time daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2013)
181
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2012)
152
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Overweight (BMI 25 to 42 kg/m2 inclusive) males age 18 to 60 inclusive
  2. All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
  3. Previously or concurrently diagnosed as having secondary hypogonadism characterized as having 2 consecutive morning testosterone assessments < 300ng/dL, one of which must be confirmed at Baseline.
  4. LH < 9.4 mIU/mL (at Visit 1 only)
  5. Sperm count ≥ 15 million per milliliter (assessed twice at least 48 hours apart)
  6. Ability to complete the study in compliance with the protocol
  7. Ability to understand and provide written informed consent
  8. Agreement to provide a total of up to 6 semen sample in a sponsor-approved clinic on up to 6 separate occasions.

Exclusion Criteria:

  1. Any prior use of testosterone treatments within the last 6 months
  2. Use of 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) or Baseline, based on the Investigator's assessment
  6. A hematocrit >54% or a hemoglobin >17 g/dL (sponsor may approve enrollment of subjects with hemoglobin up to 17.5 g/dL if the subject is at a location with a high elevation)
  7. 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.
  8. Known hypersensitivity to Clomid
  9. Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based on 0-4 scale or any trace of posterior subcapsular cataract)
  10. Abnormal fundoscopy exam such as central retinal vein occlusion
  11. 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
  12. Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary)
  13. Current or history of breast cancer
  14. Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA>3.6
  15. Presence or history of known hyperprolactinemia with or without a tumor
  16. Chronic use of medications such as glucocorticoids
  17. History of drug abuse or chronic narcotic use including methadone
  18. A recent history of alcoholism or illegal substance or steroid abuse (<2 years) or presence of moderate alcohol use (>21 drinks per week)
  19. Subjects with known history of HIV and/or Hepatitis C
  20. Subjects with end stage renal disease
  21. History of liver disease (including malignancy) or a confirmed AST or ALT >3 times the upper limit of normal
  22. History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia or know history of QTc interval prolongation
  23. History of cerebrovascular disease
  24. History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism)
  25. History of erythrocytosis or polycythemia
  26. Subjects with cystic fibrosis (mutation of the CFTR gene)
  27. Subjects unable to provide a semen sample in a sponsor-approved clinic
  28. Enrollment in a previous Androxal study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01739595
Other Study ID Numbers  ICMJE ZA-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Repros Therapeutics Inc.
Study Sponsor  ICMJE Repros Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Joseph S Podolski Repros Therapeutics Inc.
PRS Account Repros Therapeutics Inc.
Verification Date May 2015

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