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Oral T7 Oral Testosterone in Man

NCT00842751 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2014-01-13

Study results available
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Summary

The purpose of this study is to test how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future.

Conditions

  • Healthy Males
  • Male Contraceptive

Interventions

DRUG

First Intervention (7 days)

Acyline 300mcg/kg subcutaneous (days 1, 15 \& 29) + testosterone undecanoate 200 mg, twice daily orally + finasteride placebo

OTHER

First Washout (7 days)

Washout of 7 days between each of the 3 treatment arms

DRUG

Second Intervention (7 days)

Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + finasteride 0.5mg twice daily, orally

DRUG

Third Intervention (7 days)

Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + finasteride 1mg twice daily, orally

OTHER

Second wash-out period

Washout of 7 days between each of the 3 treatment arms

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, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-11-30
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT00842751 on ClinicalTrials.gov