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%

NCT ID: NCT01993212

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-09-30

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%.

Conditions

Secondary Hypogonadism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Androxal Placebo and Gel Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Capsules

Intervention Type: DRUG

Placebo Gel

Intervention Type: DRUG

AndroGel Treatment

AndroGel 1.62% and Placebo Capsules

Group Type: ACTIVE_COMPARATOR

AndroGel 1.62%

Intervention Type: DRUG

Placebo Capsules

Intervention Type: DRUG

Androxal Treatment

Androxal 12.5 mg or 25mg and Placebo Gel

Group Type: EXPERIMENTAL

Androxal 12.5 mg or 25 mg

Intervention Type: DRUG

Placebo Gel

Intervention Type: DRUG

Interventions

Androxal 12.5 mg or 25 mg

Intervention Type: DRUG

AndroGel 1.62%

Intervention Type: DRUG

Placebo Capsules

Intervention Type: DRUG

Placebo Gel

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Repros Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jacksonville, Florida, United States

Albany, New York, United States

Raleigh, North Carolina, United States

Cleveland, Ohio, United States

Medford, Oregon, United States

Warwick, Rhode Island, United States

Houston, Texas, United States

Webster, Texas, United States

Countries

United States

Other Identifiers

ZA-304

Identifier Type: -

Identifier Source: org_study_id