Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men

Verified by: Clarus Therapeutics, Inc., August 2010
First Received: June 9, 2008 | Last Updated: August 23, 2010 | Phase: Phase 2 | Start Date: June 2008
Overall Status: Completed | Estimated Enrollment: 29
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The purpose of this pharmacokinetic study is to determine whether oral testosterone ester formulations can be used effectively to treat men with low testosterone...

Brief Summary

Official Title: “Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men”

The purpose of this pharmacokinetic study is to determine whether oral testosterone ester formulations can be used effectively to treat men with low testosterone.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

  • Drug: Testosterone undecanoate (TU)
    • 300 mg T equivalents BID for 7 days
  • Drug: TU + testosterone enanthate (TE)
    • 400 mg T equivalents BID for 7 days
  • Drug: Testosterone undecanoate (TU)
    • 200 mg T equivalents BID for 8 days; pharmacokinetics determined when oral TU administered with and without food.
  • Drug: TU + testosterone enanthate (TE)
    • 300 mg T equivalents BID for 7 days

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Testosterone undecanoate (TU) (300 mg T equivalents) BID for 7 days
  • Experimental: 2
    • TU + testosterone enanthate (TE) (400 mg T equivalents) BID for 7 days
  • Experimental: 3
    • TU (200 mg T equivalents) BID for 8 days
  • Experimental: 4
    • TU + TE (300 mg T equivalents) BID for 7 days

Outcome Measures for this Clinical Trial

Primary Measures

  • Serum testosterone Cmax
    • Time Frame: 7 day treatment cycles with washouts
      Safety Issue?: Yes
  • Serum testosterone Cavg
    • Time Frame: 7 day treatment cycles with washouts
      Safety Issue?: Yes
  • Serum testosterone Tmax
    • Time Frame: 7 day treatment cycles with washouts
      Safety Issue?: No
  • Serum testosterone AUC
    • Time Frame: 7 day treatment cycles with washouts
      Safety Issue?: No

Secondary Measures

  • Serum DHT Cmax
    • Time Frame: 7 day treatment cycles with washouts
      Safety Issue?: No
  • Serum DHT Cavg
    • Time Frame: 7 day treatment cycles with washouts
      Safety Issue?: No
  • Serum DHT Tmax
    • Time Frame: 7 day treatment cycles with washout
      Safety Issue?: No
  • Serum DHT AUC
    • Time Frame: 7 day treatment cycles with washouts
      Safety Issue?: No
  • Mean serum estradiol
    • Time Frame: 7 day treatment cycles with washout
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Male, ages 18-68
  • Serum total testosterone less than or equal to 275 ng/dL

Exclusion Criteria:

  • Significant intercurrent disease of any type, in particular, liver, kidney or heart disease, uncontrolled diabetes mellitus or psychiatric illness.
  • Abnormal prostate digital rectal examination, elevated PSA, AUA symptom score of >15, and/or history of prostate cancer.
  • Hematocrit of <35 or >50%
  • BMI >36
  • Serum transaminases > 2 times upper limit of normal or serum bilirubin > 2.0 mg/dL

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 68 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Clarus Therapeutics, Inc. Industry

Overall Clinical Trial Officials and Contacts

Ronald S Swerdloff, M.D. Principal Investigator Los Angeles Biomedical Research Institute  

Additional Information

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00695110

Study ID Number: CLAR-08005

ClinicalTrials.gov Identifier: NCT00695110

Health Authority: United States: Food and Drug Administration

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