Pharmacokinetic Study to Determine Time to Steady-state

This study has been completed.
Sponsor:
Information provided by:
Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00911586
First received: May 29, 2009
Last updated: August 17, 2010
Last verified: August 2010
  Purpose

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.

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911586

Locations
United States, Alabama
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Sponsors and Collaborators
Clarus Therapeutics, Inc.
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert E. Dudley, PhD, President and CEO, Clarus Therapeutics, Inc.
ClinicalTrials.gov 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:
Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 19, 2014