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%

Completed · Phase 3 · Has a placebo group

Conditions studied: Secondary Hypogonadism

In brief

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 12.5 mg or 25 mg Androxal or AndroGel 1.62%.

Key facts

Study ID

NCT01993225

Run by

Repros Therapeutics Inc.

People needed

120

Starts

2014-01-01

Expected to finish

2014-08-01

Last updated by the study team

2014-10-01

Who can join

Age: 18 and older, up to 60. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Evanston, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — Garden City, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Nashville, Tennessee, United States
• Study site — Riverton, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.