Back to resultsPharmacokinetic Study to Determine Time to Steady-state
Primary Purpose
Male Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Testosterone undecanoate
Sponsored by
About this trial
This is an interventional treatment trial for Male Hypogonadism
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Alabama Clinical Therapeutics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Testosterone Undecanoate
Arm Description
Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00911586
First Posted
May 29, 2009
Last Updated
December 10, 2020
Sponsor
Clarus Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00911586
Brief Title
Pharmacokinetic Study to Determine Time to Steady-state
Official Title
Pharmacokinetic Study to Determine Time to Steady-state of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clarus Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Serum testosterone levels will be obtained in hypogonadal (serum testosterone <300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Testosterone Undecanoate
Arm Type
Experimental
Arm Description
Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.
Intervention Type
Drug
Intervention Name(s)
Testosterone undecanoate
Primary Outcome Measure Information:
Title
Serum T Concentration at Steady State
Description
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.
Time Frame
pre-dose on Days 1, 3, 5, 6, and 7
Title
Serum T Concentration at Steady-State
Description
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.
Time Frame
pre-dose on Days 10, 14, 17, 21, 24, 27, and 28
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Flippo, MD
Organizational Affiliation
Alabama Clinical Therapeutics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alabama Clinical Therapeutics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21474786
Citation
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.
Results Reference
derived
Learn more about this trial
Pharmacokinetic Study to Determine Time to Steady-state
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