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

This study has been completed.
Sponsor:
Collaborators:
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
First received: April 18, 2008
Last updated: December 27, 2010
Last verified: December 2010
History of Changes
  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
Drug: Finasteride
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Androgens in Man-6: Pharmacokinetics of Slow and Fast Release, External Matrix Oral Testosterone Formulations in Normal Men With Experimental Hypogonadism

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

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 [ Time Frame: 14-days ] [ Designated as safety issue: No ]
  • Area Under the Curve-E2 [ Time Frame: 14 Days ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: October 2008
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral testosterone
(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.
Other Name: Oral Testosterone
Experimental: Finasteride plus Oral Testosterone
(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.
 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.
Other Name: Oral Testosterone
Drug: Finasteride
1 mg PO once daily [day -2 to day 12) 14 days total
Other Names:
  • Proscar, Propecia, Fincar, Finpecia, Finax, Finast, Finara, Finalo,
  • Prosteride, Gefina, Appecia, Finasterid IVAX, Finasterid Alternova,
  • Hyplafin, Penester, Finpros, Tectum, Prezepa

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.

  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

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
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
University of Washington  This link exits the ClinicalTrials.gov site

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

Responsible Party: John K Amory, MD, MPH, University of Washington
ClinicalTrials.gov Identifier: NCT00663793     History of Changes
Other Study ID Numbers: 33738-B, U54HD42456-06, K23 HD045386
Study First Received: April 18, 2008
Results First Received: June 25, 2010
Last Updated: December 27, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Washington:
Male Contraception
Hypogonadism
Testosterone

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Androgens
Methyltestosterone
Finasteride
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013