Pharmacokinetic Study to Determine Time to Steady-state

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00911586
Recruitment Status : Completed
First Posted : June 2, 2009
Last Update Posted : August 19, 2010
Information provided by:
Clarus Therapeutics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Male Hypogonadism Primary Hypogonadism Secondary Hypogonadism Drug: Testosterone undecanoate Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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.
Study Start Date : July 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : January 2010

Intervention Details:
    Drug: Testosterone undecanoate
    Oral testosterone undecanoate, twice daily for one month.

Primary Outcome Measures :
  1. Confirmation of time to reach steady-state when oral testosterone undecanoate is administered twice daily. [ Time Frame: One month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: June 2, 2009    Key Record Dates
Last Update Posted: August 19, 2010
Last Verified: August 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