- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01993212
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%
September 29, 2014 updated by: Repros Therapeutics Inc.
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%.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Jacksonville, Florida, United States
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New York
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Albany, New York, United States
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North Carolina
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Raleigh, North Carolina, United States
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Ohio
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Cleveland, Ohio, United States
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Oregon
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Medford, Oregon, United States
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Rhode Island
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Warwick, Rhode Island, United States
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Texas
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Houston, Texas, United States
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Webster, Texas, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: AndroGel Treatment
AndroGel 1.62% and Placebo Capsules
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Placebo Comparator: Placebo
Androxal Placebo and Gel Placebo
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Experimental: Androxal Treatment
Androxal 12.5 mg or 25mg and Placebo Gel
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the proportion of subjects meeting the composite endpoint for normal morning testosterone and semen concentration.
Time Frame: 16 weeks of treatment
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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%.
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16 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
November 13, 2013
First Submitted That Met QC Criteria
November 20, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Estimate)
October 1, 2014
Last Update Submitted That Met QC Criteria
September 29, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Gonadal Disorders
- Hypogonadism
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Estrogen Antagonists
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Androgens
- Testosterone
- Enclomiphene
Other Study ID Numbers
- ZA-304
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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