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

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00663793
First received: April 18, 2008
Last updated: December 27, 2010
Last verified: December 2010
  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:


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
Investigators
Principal Investigator: John K Amory University of Washington
  More Information

Additional Information:
Publications:
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 April 17, 2014