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: Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study

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

Primary Measures

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

Secondary Measures

• Serum DHT, E2, TU, and TE pharmacokinetic parameters
  • Time Frame: 7 day treatment cycles with washouts
    Safety Issue?: No

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

Lead Sponsor: Clarus Therapeutics, Inc.

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on August 28, 2008

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