Oral T7 Oral Testosterone in Man (Oral T7)

December 10, 2013 updated by: John Amory, University of Washington

Pharmacokinetics of a Novel Oral Testosterone Undecanoate Formulation With Concomitant Inhibition of 5alpha-Reductase by Finasteride

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We will be using three drugs: The first, acyline, temporarily turns off the body's production of testosterone for about two weeks. Subjects will receive acyline as shots three times over a six-week drug administration period. During the time when the body's production of testosterone is turned off, we will give testosterone either by itself or with a medication called finasteride by mouth twice daily for one week to see how much is absorbed and present in the bloodstream after administration. Subjects will go through three one-week study drug exposure periods. During two of the three one-week study drug administration periods subjects will also take a second medication, finasteride, by mouth twice daily. On the last day of each one-week drug administration period, subjects will be admitted to the University of Washington General Clinical Research Center overnight for monitoring of your blood testosterone levels. There will be 3 overnight visits for this study. This study will allow us to determine the absorption of testosterone taken by mouth, and the relative impact of two different doses of oral finasteride on testosterone absorption.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males between 18 and 50 years of age
  • In good health based on normal screening evaluation (consisting of a medical history, physical exam normal serum chemistry, hematology, and baseline hormone levels.
  • Must agree to not participate in another research drug study
  • Must agree to not donate blood
  • Must be willing to comply with the study protocol and procedures

Exclusion Criteria:

  • Men in poor general health, with abnormal blood results (clinical laboratory tests or hormone values)
  • A known history of alcohol or drug abuse
  • Participation in a long-term male contraceptive study within the past month
  • History of bleeding disorders or current use of anti-coagulants
  • History of sleep apnea
  • History of major psychiatric disorder
  • Body mass index > 37
  • Infertility
  • Hematocrit > 55 or < 30
  • PSA >4

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Testosterone Undecanoate + placebo finasteride
Acyline 300mcg/kg subcutaneous on days 1, 15 and 29 + Testosterone Undecanoate (TU)200mg twice daily, orally for 7 days + placebo finasteride twice daily, orally for 7 days during one of the three intervention periods (First Intervention, Second Intervention or Third Intervention)
Drug: First Intervention (7 days)
Acyline 300mcg/kg subcutaneous (days 1, 15 & 29) + testosterone undecanoate 200 mg, twice daily orally + finasteride placebo
Other Names:
  • propecia
Other: First Washout (7 days)
Washout of 7 days between each of the 3 treatment arms
Other Names:
  • no active drugs
Experimental: Testosterone Undecanoate + Finasteride 0.5mg
Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + testosterone undecanoate 200mg, twice daily orally for 7 days + finasteride 0.5mg twice daily, orally for 7 days during one of the three intervention periods (First Intervention, Second Intervention or Third Intervention)
Drug: Second Intervention (7 days)
Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + finasteride 0.5mg twice daily, orally
Other Names:
  • propecia
Other: Second wash-out period
Washout of 7 days between each of the 3 treatment arms
Other Names:
  • no active drug
Experimental: Testosterone Undecanoate + Finasteride 1mg
Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + testosterone undecanoate 200mg, twice daily orally for 7 days + finasteride 1mg twice daily, orally for 7 days during one of the three intervention periods ((First Intervention, Second Intervention or Third Intervention)
Drug: Third Intervention (7 days)
Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + finasteride 1mg twice daily, orally
Other Names:
  • propecia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Testosterone Concentration
Time Frame: 0,1,2,4,8,and 12-hour post dose
Area under the curve of serum testosterone Pharmacokinetic measures time-weighted mean concentration calculated as area under the concentration curve (AUC) divided by time from initiation of dosing for the morning dose and corrected for differences in baseline hormone concentration.
0,1,2,4,8,and 12-hour post dose
Serum Dihydrotestosterone Concentration
Time Frame: 0,1,2,4,8,and 12-hour post dose
Area under the curve of serum dihydrotestosterone
0,1,2,4,8,and 12-hour post dose
Serum Estradiol Concentration
Time Frame: 0,1,2,4,8,and 12-hour post dose
Area under the curve of serum estradiol
0,1,2,4,8,and 12-hour post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35724-W
  • 1K23HD045386 (U.S. NIH Grant/Contract)
  • 5U54HD042454 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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