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ORAL T-6: Oral Androgens in Man-6 (ORAL-T-6)

Primary Purpose

Contraception, Hypogonadism

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acyline
Testosterone
Finasteride
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contraception focused on measuring Male Contraception, Hypogonadism, Testosterone

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • males between 18 to 50 years of age in good general health based on normal screening evaluation
  • must agree not to participate in another research drug study during participation
  • must agree to not donate blood during the study
  • must be willing to comply with the study protocol and procedures
  • must agree to use an acceptable form of contraception
  • agrees to not take medications other than the study drugs for the duration of the study

Exclusion Criteria:

  • Subject in poor health, determined by medical history physical and lab results
  • a known history or current use of alcohol, drug or steroid abuse and/or use of more than 3 alcohol beverages per day
  • Participation in a long-term contraceptive study within the past two months
  • History of bleeding disorders or current use of anti-coagulants
  • History of sleep apnea and/or major psychiatric disorders

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Oral testosterone

Finasteride plus Oral Testosterone

Arm Description

(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.

(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.

Outcomes

Primary Outcome Measures

Area Under the Curve-Serum T

Secondary Outcome Measures

Area Under the Curve-serum DHT
Area Under the Curve-E2

Full Information

First Posted
April 18, 2008
Last Updated
December 27, 2010
Sponsor
University of Washington
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00663793
Brief Title
ORAL T-6: Oral Androgens in Man-6
Acronym
ORAL-T-6
Official Title
Oral Androgens in Man-6: Pharmacokinetics of Slow and Fast Release, External Matrix Oral Testosterone Formulations in Normal Men With Experimental Hypogonadism
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Washington
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.
Detailed Description
This is an 2-3 month open-label, two week pharmacokinetic study of two novel formulations of oral testosterone (T), in normal men whose endogenous T production has been temporarily suppressed by the administration of the potent GnRH antagonist Acyline. We will be determining the relative pharmacokinetics of six different oral formulations of T in both rapid and slow release compared to the immediate release preparation studied previously by our group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception, Hypogonadism
Keywords
Male Contraception, Hypogonadism, Testosterone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral testosterone
Arm Type
Experimental
Arm Description
(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
Arm Title
Finasteride plus Oral Testosterone
Arm Type
Experimental
Arm Description
(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
Intervention Type
Drug
Intervention Name(s)
Acyline
Intervention Description
300 mcg/kg
Intervention Type
Drug
Intervention Name(s)
Testosterone
Other Intervention Name(s)
Oral Testosterone
Intervention Description
24 hours after acyline administration on Day 2 "immediate release" Testosterone (T) 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
Intervention Type
Drug
Intervention Name(s)
Finasteride
Other Intervention Name(s)
Proscar, Propecia, Fincar, Finpecia, Finax, Finast, Finara, Finalo,, Prosteride, Gefina, Appecia, Finasterid IVAX, Finasterid Alternova,, Hyplafin, Penester, Finpros, Tectum, Prezepa
Intervention Description
1 mg PO once daily [day -2 to day 12) 14 days total
Primary Outcome Measure Information:
Title
Area Under the Curve-Serum T
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Area Under the Curve-serum DHT
Time Frame
14-days
Title
Area Under the Curve-E2
Time Frame
14 Days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: males between 18 to 50 years of age in good general health based on normal screening evaluation must agree not to participate in another research drug study during participation must agree to not donate blood during the study must be willing to comply with the study protocol and procedures must agree to use an acceptable form of contraception agrees to not take medications other than the study drugs for the duration of the study Exclusion Criteria: Subject in poor health, determined by medical history physical and lab results a known history or current use of alcohol, drug or steroid abuse and/or use of more than 3 alcohol beverages per day Participation in a long-term contraceptive study within the past two months History of bleeding disorders or current use of anti-coagulants History of sleep apnea and/or major psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John K Amory
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Plymate SR "Male Hypogonadism" in Principles and Practice of Endocrinology and Metabolism (3rd. Ed). Ed. Kenneth Becker, pp:1125-1150
Results Reference
background
PubMed Identifier
15713724
Citation
Amory JK, Bremner WJ. Oral testosterone in oil plus dutasteride in men: a pharmacokinetic study. J Clin Endocrinol Metab. 2005 May;90(5):2610-7. doi: 10.1210/jc.2004-1221. Epub 2005 Feb 15.
Results Reference
background
PubMed Identifier
16400081
Citation
Amory JK, Page ST, Bremner WJ. Oral testosterone in oil: pharmacokinetic effects of 5alpha reduction by finasteride or dutasteride and food intake in men. J Androl. 2006 Jan-Feb;27(1):72-8. doi: 10.2164/jandrol.05058.
Results Reference
background
PubMed Identifier
15579744
Citation
Herbst KL, Coviello AD, Page S, Amory JK, Anawalt BD, Bremner WJ. A single dose of the potent gonadotropin-releasing hormone antagonist acyline suppresses gonadotropins and testosterone for 2 weeks in healthy young men. J Clin Endocrinol Metab. 2004 Dec;89(12):5959-65. doi: 10.1210/jc.2003-032123.
Results Reference
background
PubMed Identifier
20378927
Citation
Snyder CN, Clark RV, Caricofe RB, Bush MA, Roth MY, Page ST, Bremner WJ, Amory JK. Pharmacokinetics of 2 novel formulations of modified-release oral testosterone alone and with finasteride in normal men with experimental hypogonadism. J Androl. 2010 Nov-Dec;31(6):527-35. doi: 10.2164/jandrol.109.009746. Epub 2010 Apr 8.
Results Reference
result
Links:
URL
http://depts.washington.edu/popctr/
Description
University of Washington

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ORAL T-6: Oral Androgens in Man-6

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