Androxal in Male Infertility

• Status: Withdrawn
• Trial end date: 2016-08-02
• Target enrollment: 0
• Participant gender: Male

Summary

This is an exploratory, single center, randomized, parallel, double-blind placebo- and active-controlled trial in adult males ages 18 to 35 years of age who have male infertility of unknown cause. Approximately 50 men will be randomly assigned to one of two treatment groups according to a 1:1 ratio. About half of the men will receive 25mg Androxal and half of the men will receive a placebo (non-active pill) for 16 weeks. This study will last approximately 4 months and involve up to 7 visits.

The purpose of this study is to determine the effect the Androxal on sperm production.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Zuclomiphene

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)