Oral T7 Oral Testosterone in Man

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
John Amory, University of Washington
ClinicalTrials.gov Identifier:
NCT00842751
First received: February 10, 2009
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Healthy Males
Male Contraceptive
Drug: First Intervention (7 days)
Other: First Washout (7 days)
Drug: Second Intervention (7 days)
Drug: Third Intervention (7 days)
Other: Second wash-out period
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of a Novel Oral Testosterone Undecanoate Formulation With Concomitant Inhibition of 5alpha-Reductase by Finasteride

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Maximum Testosterone Concentration [ Time Frame: 0,1,2,4,8,and 12-hour post dose ] [ Designated as safety issue: No ]
    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.

  • Serum Dihydrotestosterone Concentration [ Time Frame: 0,1,2,4,8,and 12-hour post dose ] [ Designated as safety issue: No ]
    Area under the curve of serum dihydrotestosterone

  • Serum Estradiol Concentration [ Time Frame: 0,1,2,4,8,and 12-hour post dose ] [ Designated as safety issue: No ]
    Area under the curve of serum estradiol


Enrollment: 11
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: propecia
Other: First Washout (7 days)
Washout of 7 days between each of the 3 treatment arms
Other Name: 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 Name: propecia
Other: Second wash-out period
Washout of 7 days between each of the 3 treatment arms
Other Name: 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 Name: propecia

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.

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842751

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: John K Amory, MD, MPH University of Washington
  More Information

Additional Information:
Publications:

Responsible Party: John Amory, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00842751     History of Changes
Other Study ID Numbers: 35724-W, 1K23HD045386, 5U54HD042454
Study First Received: February 10, 2009
Results First Received: March 21, 2011
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Washington:
5α-reductase
androgen
dihydrotestosterone (DHT)
drug delivery
oestradiol

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Finasteride
Androgens
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
Urological Agents

ClinicalTrials.gov processed this record on October 01, 2014