Pharmacokinetic Study to Determine Time to Steady-state
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 2, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
December 11, 2020
CompletedDecember 11, 2020
December 1, 2020
2 months
May 29, 2009
August 31, 2020
December 10, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Serum T Concentration at Steady State
Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment.
pre-dose on Days 1, 3, 5, 6, and 7
Serum T Concentration at Steady-State
Serum T at steady-state by evaluating the day-to-day changes in pre-dose concentrations on Days 10, 14, 17, 21, 24, 27, and 28 of treatment.
pre-dose on Days 10, 14, 17, 21, 24, 27, and 28
Study Arms (1)
Testosterone Undecanoate
EXPERIMENTALOral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.
Interventions
Eligibility Criteria
You may qualify if:
- Male, age 18-75
- Morning serum testosterone (T) \<300 ng/dL on two occasions
- Naive to androgen-replacement therapy or willing to wash-out from current T therapy
You may not qualify if:
- Significant intercurrent disease
- Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score \>15 or history of prostate cancer.
- Serum transaminases \>2 times upper limit of normal
- Serum bilirubin \>2.0 mg/dL
- Hematocrit \<35% or \>50%
- BMI \>36
- Untreated, obstructive sleep apnea.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
Related Publications (1)
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.
PMID: 21474786DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert E. Dudley, PhD, CEO and President
- Organization
- Clarus Therapeutics, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Flippo, MD
Alabama Clinical Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2009
First Posted
June 2, 2009
Study Start
July 1, 2009
Primary Completion
September 1, 2009
Study Completion
January 1, 2010
Last Updated
December 11, 2020
Results First Posted
December 11, 2020
Record last verified: 2020-12