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A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%

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ClinicalTrials.gov Identifier: NCT01993212
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Brief Summary:
This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with the 12.5 mg or 25 mg Androxal or AndroGel 1.62%.

Condition or disease Intervention/treatment Phase
Secondary Hypogonadism Drug: Androxal 12.5 mg or 25 mg Drug: AndroGel 1.62% Drug: Placebo Capsules Drug: Placebo Gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Androxal Placebo and Gel Placebo
Drug: Placebo Capsules
Drug: Placebo Gel
Active Comparator: AndroGel Treatment
AndroGel 1.62% and Placebo Capsules
Drug: AndroGel 1.62%
Drug: Placebo Capsules
Experimental: Androxal Treatment
Androxal 12.5 mg or 25mg and Placebo Gel
Drug: Androxal 12.5 mg or 25 mg
Drug: Placebo Gel



Primary Outcome Measures :
  1. Comparison of the proportion of subjects meeting the composite endpoint for normal morning testosterone and semen concentration. [ Time Frame: 16 weeks of treatment ]
    Comparison of the proportion of subjects whose morning testosterone levels are within the normal range [300-1,040 ng/dL] and whose sperm concentration is 15 million/mL or greater following 16 weeks of treatment with Androxal, placebo or AndroGel 1.62%.


Secondary Outcome Measures :
  1. Proportion of subjects with mean sperm concentration less than 15 million/mL after 16 weeks of treatment comparing Androxal to placebo in a non-inferiority assessment [ Time Frame: 16 weeks ]


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
Criteria

Inclusion Criteria:

  • Overweight (BMI 25 to 42 kg/m2 inclusive) males age 18 to 60 inclusive
  • Previously or concurrently diagnosed as having secondary hypogonadism characterized as having at least 2 consecutive morning testosterone assessments < 300ng/dL, one of which must be confirmed at Baseline.
  • LH < 9.4 mIU/mL (at Visit 1 only)
  • Sperm concentration ≥ 15 million per milliliter (assessed at V2 and Baseline). V2 and Baseline measurements must be at least 48 hours apart.
  • Ability to complete the study in compliance with the protocol
  • Ability to understand and provide written informed consent
  • Agreement to provide a total of at least 4 semen samples in a sponsor-approved clinic on 4 separate occasions.

Exclusion Criteria:

  • Any prior use of testosterone treatments (injectable, pelleted, transdermal or sublingual) within the last 6 months
  • Use of 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
  • Any clinically significant laboratory abnormality that does not have prior written sponsor approval. If the sponsor approves subject enrollment, this will not be considered to be a protocol deviation.
  • 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, if considered clinically stable by the investigator. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
  • A hematocrit >54
  • 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 evidence 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
  • Have received a diagnosis of irreversible infertility or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary), or history of evaluation or treatment for low fertility
  • Current or history of breast cancer
  • 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 (prolactin > 20 ng/mL).
  • Chronic use of medications such as glucocorticoids (chronic use of inhaled or topical glucocorticoids is acceptable)
  • History of drug abuse or chronic narcotic use including methadone
  • A recent history of alcoholism or illegal substance or steroid abuse (<2 years) or presence of moderate alcohol use (>21 drinks per week)
  • Subjects with known history of HIV and/or Hepatitis C
  • Subjects with end stage renal disease
  • History of liver disease (including malignancy) or a confirmed AST or ALT >3 times the upper limit of normal
  • History of clinically relevant myocardial infarction (within the previous year), unstable angina, symptomatic heart failure, ventricular dysrhythmia or know history of QTc interval prolongation
  • History of clinically relevant cerebrovascular disease
  • History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism)
  • History of erythrocytosis or polycythemia
  • Subjects unable to provide a semen sample in a sponsor-approved clinic
  • Enrollment in a previous Androxal study
  • Subjects who have Type I Diabetes

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 ClinicalTrials.gov identifier (NCT number): NCT01993212


Locations
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United States, Florida
Jacksonville, Florida, United States
United States, New York
Albany, New York, United States
United States, North Carolina
Raleigh, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Oregon
Medford, Oregon, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, Texas
Houston, Texas, United States
Webster, Texas, United States
Sponsors and Collaborators
Repros Therapeutics Inc.

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Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01993212     History of Changes
Other Study ID Numbers: ZA-304
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014
Keywords provided by Repros Therapeutics Inc.:
Low Testosterone
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Enclomiphene
Clomiphene
Zuclomiphene
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Estrogen Antagonists
Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators