Oral Androgens in Man-6 - Full Text View

Sponsors and Collaborators:	University of Washington National Institutes of Health (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00663793

Purpose

We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.

Condition	Intervention	Phase
Contraception Hypogonadism	Drug: Acyline Drug: Testosterone	Phase I

MedlinePlus related topics: Birth Control

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Acyline Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	Oral Androgens in Man-6: Pharmacokinetics of Slow and Fast Release, External Matrix Oral Testosterone Formulations in Normal Men With Experimental Hypogonadism

Further study details as provided by University of Washington:

Primary Outcome Measures:

Area under the curve-Serum T [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Area under the curve-serum DHT, E2 and side effects [ Time Frame: 14-days ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental (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.	Drug: Acyline 300 mcg/kg Drug: 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.

Arms

Assigned Interventions

1: Experimental

(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.

Drug: Acyline

300 mcg/kg

Drug: 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.

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 formulation of T in both rapid and slow release compared to the immediate release preparation studied previously by our group.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663793

Contacts

Contact: John K Amory, MD	206-616-1727	jamory@u.washinton.edu
Contact: Kymberley Anable	206-616-0482	kymmkatt@u.washington.edu

Locations

United States, Washington
University of Washington	Recruiting
Seattle, Washington, United States, 98195
Contact: Kymberley Anable 206-616-0482 kymmkatt@u.washington.edu
Contact: Kathy Winter 206-616-0484 klwinter@u.washington.edu
Sub-Investigator: William J Bremner, MD, PhD
Sub-Investigator: Stephanie T Page, MD, PhD
Sub-Investigator: Christin N Snyder, MD
Sub-Investigator: Mara Y Roth, MD

Sponsors and Collaborators

University of Washington

National Institutes of Health (NIH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

John K Amory

University of Washington

More Information

Additional Information:

University of Washington This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

Responsible Party:	University of Washington ( John K Amory, MD, MPH )
Study ID Numbers:	33738-B, U54 HD42456-06, K23 HD045386
Study First Received:	April 18, 2008
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00663793 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Washington:

Male Contraception
Hypogonadism
Testosterone

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Testosterone 17 beta-cypionate
Testosterone
Anabolic Agents
Hypogonadism
Endocrinopathy
Androgens

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on May 07, 2009