Last updated on February 2019

Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hypogonadism | Urology | Hormone Deficiencies
  • Age: Between 18 - 80 Years
  • Gender: Male

Inclusion Criteria:

  • Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadism prior to age 65.
  • Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy.

Exclusion Criteria:

  • History of significant sensitivity or allergy to androgens, or product excipients.
  • History of seizures or convulsions occurring after age 5, including alcohol or drug withdrawal seizures.
  • History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
  • History of stroke, myocardial infarction, transient ischemic attack, or acute coronary syndrome within the past 5 years.
  • Subjects who are not on stable dose of current medication (no changes in medication in the last 3 months).
  • History of untreated obstructive sleep apnea or not compliant with sleep apnea treatment.
  • Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior to study drug administration and through the end of the study.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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