ORAL T-6: Oral Androgens in Man-6

Contraception Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663793
• Other study ID #: 33738-B
• Secondary ID: U54HD42456-06K23
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2008
• Last updated: December 27, 2010
• Start date: October 2008
• Est. completion date: June 2009

Study information

• Verified date: December 2010
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception
• Hypogonadism

Intervention

Drug:
• Acyline
300 mcg/kg
• Testosterone
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.
• Finasteride
1 mg PO once daily [day -2 to day 12) 14 days total

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Epub 2005 Feb 15. — View 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. — View 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. — View Citation

Plymate SR "Male Hypogonadism" in Principles and Practice of Endocrinology and Metabolism (3rd. Ed). Ed. Kenneth Becker, pp:1125-1150

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-D — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve-Serum T		14 days	No
Secondary	Area Under the Curve-serum DHT		14-days	No
Secondary	Area Under the Curve-E2		14 Days	No

External Links

•   University of Washington