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%
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Repros Therapeutics Inc.
Age
18–60
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Subjects unable to provide a semen sample in a sponsor-approved clinic
Enrollment in a previous Androxal study
Subjects who have Type I Diabetes
Clareo Health | 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%
