Androxal in Male Infertility

Launched by BAYLOR COLLEGE OF MEDICINE · Jun 9, 2014

Keywords

ClinConnect Summary

It has been estimated that 4 to 5 million men in the United States are testosterone deficient, but fewer than 10% currently receive testosterone replacement therapy. There are many reasons for the low number of men receiving testosterone replacement therapy, one of which is the route of administration. The currently approved androgen therapies are oral products, injectables, patches, buccal systems, and gels, and each has disadvantages. Oral preparations may be associated with hepatotoxicity and produce unfavorable effects on serum lipid profiles and carbohydrate metabolism. Injectables are...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Men having idiopathic male infertility with sperm concentration \<15million/ml (on 2 baseline semen analyses)
• • Serum total testosterone \< 300ng/dL if oligospermia (sperm concentration \<15million/ml)
• • Any testosterone if nonobstructive azoospermia (no sperm in the ejaculate)
• • Men aged 18-35 living in stable relationship and desiring fertility
• • Normal female partner evaluation as reported by the patient
• • Ability to complete the study in compliance with the protocol
• • Ability to understand and provide written informed consent
• Exclusion Criteria:
• • Men desiring operation for fertility (i.e. varicocelectomy) or couples desiring assisted reproductive technologies such as intrauterine insemination IUI, in vitro fertilization IVF and intracytoplasmic sperm injection ICSI) within study completion (5 months)
• • Clinically significant medical condition rendering the subjects infertile including tumors of the pituitary, laboratory abnormalities
• • Patients having received an investigational drug / clomiphene citrate, antioxidants, multi-vitamin in the past 30 days prior to study
• • Previous treatment with androgens, estrogens, DHEA, testosterone or testosterone analogues in injectable, oral, topical or other forms for the treatment of AIHH who have not discontinued for at least 1 month prior to the start of the treatment phase
• • Clinically significant abnormal findings on screening examination as determined by the investigator
• • Known hypersensitivity to clomiphene citrate
• • Current or history of breast cancer
• • Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with the study instructions, possibly confound interpretation of the study results, or endanger the participant if he took part in the study
• • Have received a diagnosis of irreversible infertility or compromised fertility (cryptorchidism, Kallman Syndrome, vasectomy, or tumors of the pituitary)
• • Current or history of prostate cancer or a suspicion of prostate disease
• • Presence or history of known hyperprolactinemia (prolactin \> 17ng/dl) with or without a tumor
• • Chronic use of medications use such as glucocorticoids (chronic use of inhaled or topical glucocorticoids is acceptable)
• • No current drug abuse or chronic narcotic use including methadone
• • Subjects with known history of HIV and/or Hepatitis C
• • Subjects with end stage renal disease
• • Subjects with cystic fibrosis (mutation of the CFTR gene)
• • History of liver disease (including malignancy) or a confirmed AST or ALT \>3 times the upper limit of normal
• • History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia or known history of QTc interval prolongation
• • History of cerebrovascular disease
• • History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism)
• • History of erythrocytosis or polycythemia (HCt \> 54)