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Completed

NCT Number: NCT00911586

Pharmacokinetic Study to Determine Time to Steady-state

The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.

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Key information

Conditions

Male Hypogonadism Endocrine System Diseases Eunuchism Gonadal Disorders Hypogonadism Primary Hypogonadism Secondary Hypogonadism

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

About this study

Serum testosterone levels will be obtained in hypogonadal (serum testosterone <300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male, age 18-75
  • Morning serum testosterone (T) <300 ng/dL on two occasions
  • Naive to androgen-replacement therapy or willing to wash-out from current T therapy

Exclusion criteria

  • Significant intercurrent disease
  • Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history of prostate cancer.
  • Serum transaminases >2 times upper limit of normal
  • Serum bilirubin >2.0 mg/dL
  • Hematocrit <35% or >50%
  • BMI >36
  • Untreated, obstructive sleep apnea.

Treatment and study plan

Testosterone Undecanoate

Drug

Primary outcomes

  1. Serum T Concentration at Steady State

    Time frame: pre-dose on Days 1, 3, 5, 6, and 7

    Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment.

  2. Serum T Concentration at Steady-State

    Time frame: pre-dose on Days 10, 14, 17, 21, 24, 27, and 28

    Serum T at steady-state by evaluating the day-to-day changes in pre-dose concentrations on Days 10, 14, 17, 21, 24, 27, and 28 of treatment.

Sponsors and collaborators

Lead sponsor

Clarus Therapeutics, Inc.

Industry

Registry information

Official study title

Pharmacokinetic Study to Determine Time to Steady-state of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men.

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jun 2, 2009
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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