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ORAL T-8 Oral Testosterone for Male Hormonal Contraception (Oral T-8)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Washington.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01167829
First received: July 20, 2010
Last updated: October 27, 2010
Last verified: October 2010
History of Changes
  Purpose

The purpose of this study is to test how the body absorbs a new form of oral testosterone (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at the University of Washington to monitor blood testosterone levels over a 24-hour period.


Condition Intervention Phase
Healthy
 Drug: Acyline and Oral Testosterone
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pharmacokinetics of Modified Slow-Release Oral Testosterone Over 10 Days in Normal Men With Experimental Hypogonadism

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • To test how the body absorbs a new form of oral testosterone. [ Time Frame: 2 month period ] [ Designated as safety issue: Yes ]
    Volunteers will be asked to come to the University of Washington Medicine Center, about 6 visits including two overnight stays (24 hr each) during the drug phase.


Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Acyline and Oral Testosterone
    Acyline: 300 ug/kg injection on Day 0 Oral Testosterone: 300 mg, pills, three times daily Day 1 - 10 (total of 27 pills)
Detailed Description:

We will administer two experimental drugs, acyline and oral testosterone. Acyline shots will be given on Day 0 to turn off the body's testosterone production for about 10-14 days.

The next day, Day 1, subjects begin taking 300 mg modified slow-release testosterone pill by mouth, three times a day, around 9 AM, 1 PM, and 7 PM for a total of 27 pills.

There are overnight stays on Day 1 and Day 9 to allow monitoring of blood testosterone levels over a 24 hour period, from @9 AM to 9 AM the next morning. At those visits, blood is drawn at baseline (before taking the pill) and at 1, 2, 4, 5, 6, 8, 10, 11, 12, 14, 16, and 24 hours after the morning dose.

Acyline is an experimental drug. The FDA allows its use only in research with a small number of volunteers. We have used acyline in over 125 men without serious side effects. The use of testosterone in this study is experimental and there may be unknown or unanticipated risks.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA:

  • able and willing to
  • not participate in another drug study or donate blood, not take medications
  • use contraception, comply with the protocol

EXCLUSION CRITERIA:

  • abnormal evaluation, based on physical exam, medical history, blood tests (including serum chemistry, hematology, HIV, HCV, hormone levels)
  • history or current use of alcohol, drug, steroid abuse, >3 alcohol drinks/day
  • history of testicular disease, severe testicular trauma, major psychiatric disorder, bleeding disorders, current use of anti-coagulants or testosterone
  • participation in hormonal drug study within past month
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167829

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:
1. Plymate SR "Male Hypogonadism" in Principles and Practice of Endocrinology and Metabolism (3rd. Ed). Ed. Kenneth Becker, pp:1125-1150

Responsible Party: John K. Amory, MD, University of Washington, Dept. of Medicine
ClinicalTrials.gov Identifier: NCT01167829     History of Changes
Other Study ID Numbers: 38636-D
Study First Received: July 20, 2010
Last Updated: October 27, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Washington:
Experimental
Acyline plus 27 oral testosterone pills
taken 3x/day

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 19, 2013