29
Participants
Start Date
June 30, 2008
Primary Completion Date
December 31, 2008
Study Completion Date
August 31, 2009
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.
Alabama Clinical Therapeutics, Birmingham
Alabama Internal Medicine, Birmingham
dgd Research, Inc., San Antonio
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles
Lead Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
OTHER
Clarus Therapeutics, Inc.
INDUSTRY