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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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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   (Adult, Senior)
Sexes 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.
  Contacts and Locations
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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

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

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on August 17, 2017