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Completed

NCT Number: NCT00663793

ORAL T-6: Oral Androgens in Man-6

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

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Key information

Conditions

Contraception Endocrine System Diseases Gonadal Disorders Hypogonadism

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acyline

Drug

300 mcg/kg

Testosterone

Drug

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 names: Oral Testosterone

finasteride

Drug

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

Primary outcomes

  1. Area Under the Curve-Serum T

    Time frame: 14 days

Secondary outcomes

  1. Area Under the Curve-serum DHT

    Time frame: 14-days

  2. Area Under the Curve-E2

    Time frame: 14 Days

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Official study title

Oral Androgens in Man-6: Pharmacokinetics of Slow and Fast Release, External Matrix Oral Testosterone Formulations in Normal Men With Experimental Hypogonadism

Acronym: ORAL-T-6

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 22, 2008
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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