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ORAL T-6: Oral Androgens in Man-6

NCT00663793 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-01-24

Study results available
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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.

Conditions

  • Contraception
  • Hypogonadism

Interventions

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.

DRUG

Finasteride

1 mg PO once daily \[day -2 to day 12) 14 days total

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

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

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • John K Amory · University of Washington

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-05-31
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00663793 on ClinicalTrials.gov