Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
NCT ID: NCT00695110
Last Updated: 2021-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
29 participants
INTERVENTIONAL
2008-06-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All study participants
Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), twice daily (BID) for 7 days.
Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID for 7 days.
Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days.
Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID for 7 days.
Oral testosterone undecanoate (TU) (300 mg T equivalents/dose)
Three capsules each containing 100 mg testosterone (T) as TU, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.
Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose)
Two capsules each containing 100 mg T as TU and 100 mg T as TE, BID. 400 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.
Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food)
Two capsules each containing 100 mg T as TU, BID for 8 days. 200 mg T equivalents BID 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods.
Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)
Two capsules each containing 150 mg T as TU and 150 mg T as TE, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days.
Interventions
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Oral testosterone undecanoate (TU) (300 mg T equivalents/dose)
Three capsules each containing 100 mg testosterone (T) as TU, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.
Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose)
Two capsules each containing 100 mg T as TU and 100 mg T as TE, BID. 400 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.
Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food)
Two capsules each containing 100 mg T as TU, BID for 8 days. 200 mg T equivalents BID 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods.
Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)
Two capsules each containing 150 mg T as TU and 150 mg T as TE, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days.
Eligibility Criteria
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Inclusion Criteria
* Serum total T less than or equal to 275 ng/dL
Exclusion Criteria
* Abnormal prostate digital rectal examination, elevated prostate-specific antigen (PSA), American Urological Association (AUA) symptom score of \>15, and/or history of prostate cancer.
* Hematocrit of \<35 or \>50%
* Body mass index (BMI) \>36
* Serum transaminases \> 2 times upper limit of normal or serum bilirubin \> 2.0 mg/dL
18 Years
68 Years
MALE
No
Sponsors
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Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
OTHER
Clarus Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ronald S Swerdloff, M.D.
Role: PRINCIPAL_INVESTIGATOR
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Gregory Flippo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Alabama Clinical Therapeutics, Inc.
Steven J. Kulback, M.D.
Role: PRINCIPAL_INVESTIGATOR
Alabama Internal Medicine
Sherwyn Schwartz, M.D.
Role: PRINCIPAL_INVESTIGATOR
dgd Research, Inc.
Locations
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Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Alabama Internal Medicine
Birmingham, Alabama, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Los Angeles, California, United States
dgd Research, Inc.
San Antonio, Texas, United States
Countries
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References
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Yin AY, Htun M, Swerdloff RS, Diaz-Arjonilla M, Dudley RE, Faulkner S, Bross R, Leung A, Baravarian S, Hull L, Longstreth JA, Kulback S, Flippo G, Wang C. Reexamination of pharmacokinetics of oral testosterone undecanoate in hypogonadal men with a new self-emulsifying formulation. J Androl. 2012 Mar-Apr;33(2):190-201. doi: 10.2164/jandrol.111.013169. Epub 2011 Apr 7.
Other Identifiers
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CLAR-08005
Identifier Type: -
Identifier Source: org_study_id
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