Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
Information source: Clarus Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism
Intervention: Testosterone undecanoate (TU) (Drug); TU + testosterone enanthate (TE) (Drug); Testosterone undecanoate (TU) (Drug); TU + testosterone enanthate (TE) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Clarus Therapeutics, Inc. Official(s) and/or principal investigator(s):
Ronald S Swerdloff, M.D., Principal Investigator, Affiliation: Los Angeles Biomedical Research Institute
Gregory Flippo, M.D., Principal Investigator, Affiliation: Alabama Clinical Therapeutics, Inc.
Steven J. Kulback, M.D., Principal Investigator, Affiliation: Alabama Internal Medicine
Sherwyn Schwartz, M.D., Principal Investigator, Affiliation: dgd Research, Inc.
Summary
The purpose of this pharmacokinetic study is to determine whether oral testosterone ester
formulations can be used effectively to treat men with low testosterone.
Clinical Details
Official title: Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Serum testosterone CmaxSerum testosterone Cavg Serum testosterone Tmax Serum testosterone AUC
Secondary outcome: Serum DHT CmaxSerum DHT Cavg Serum DHT Tmax Serum DHT AUC Mean serum estradiol
Eligibility
Minimum age: 18 Years.
Maximum age: 68 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Alabama Clinical Therapeutics, Birmingham, Alabama 35235, United States
Alabama Internal Medicine, Birmingham, Alabama 35235, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles, California 90502, United States
dgd Research, Inc., San Antonio, Texas 78229, United States
Additional Information
Starting date: June 2008
Last updated: August 23, 2010
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