Pharmacokinetic Study to Determine Time to Steady-state

This study has been completed.
Information provided by:
Clarus Therapeutics, Inc. Identifier:
First received: May 29, 2009
Last updated: August 17, 2010
Last verified: August 2010
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.

Condition Intervention Phase
Male Hypogonadism
Primary Hypogonadism
Secondary Hypogonadism
Drug: Testosterone undecanoate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study to Determine Time to Steady-state of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men.

Resource links provided by NLM:

Further study details as provided by Clarus Therapeutics, Inc.:

Primary Outcome Measures:
  • Confirmation of time to reach steady-state when oral testosterone undecanoate is administered twice daily. [ Time Frame: One month ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: July 2009
Study Completion Date: January 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Testosterone undecanoate
    Oral testosterone undecanoate, twice daily for one month.
Detailed Description:
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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00911586

United States, Alabama
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Sponsors and Collaborators
Clarus Therapeutics, Inc.
Principal Investigator: Gregory Flippo, MD Alabama Clinical Therapeutics
  More Information

No publications provided by Clarus Therapeutics, Inc.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Robert E. Dudley, PhD, President and CEO, Clarus Therapeutics, Inc. Identifier: NCT00911586     History of Changes
Other Study ID Numbers: CLAR-09009 
Study First Received: May 29, 2009
Last Updated: August 17, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Endocrine System Diseases
Gonadal Disorders
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 07, 2016