ORAL T-8 Oral Testosterone for Male Hormonal Contraception (Oral T8)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
John Amory, University of Washington
ClinicalTrials.gov Identifier:
NCT01167829
First received: July 20, 2010
Last updated: August 23, 2013
Last verified: August 2013
  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: Oral Testosterone
Drug: Acyline
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:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Maximum Testosterone Concentration [ Time Frame: baseline & day 9 ] [ Designated as safety issue: Yes ]
    initial pharmacokinetics [PK] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment

  • Mean Testosterone Concentration [ Time Frame: baseline & day 9 ] [ Designated as safety issue: Yes ]
    initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment


Secondary Outcome Measures:
  • Maximum Dihydrotestosterone (DHT) Concentration [ Time Frame: baseline & day 9 ] [ Designated as safety issue: No ]
  • Mean Dihydrotestosterone (DHT) Concentration [ Time Frame: baseline & day 9 ] [ Designated as safety issue: No ]
  • Maximum Sex Hormone-Binding Globulin (SHGB)Concentration [ Time Frame: baseline & day 9 ] [ Designated as safety issue: No ]
  • Mean SHGB Concentration [ Time Frame: baseline & day 9 ] [ Designated as safety issue: No ]
  • Maximum Estradiol Concentration [ Time Frame: baseline & day 9 ] [ Designated as safety issue: No ]
  • Mean Estradiol Concentration [ Time Frame: baseline & day 9 ] [ Designated as safety issue: No ]
  • Free T Maximum Concentration [ Time Frame: baseline & day 9 ] [ Designated as safety issue: No ]
    Free T normal range 4.7-18 ng/dL

  • Free Testosterone Mean Concentration [ Time Frame: baseline & day 9 ] [ Designated as safety issue: No ]
    Free T normal range 4.7-18 ng/dL


Enrollment: 14
Study Start Date: July 2010
Study Completion Date: June 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acyline and oral testosterone Drug: Oral Testosterone
Oral Testosterone: 300 mg, pills, three times daily Day 1 - 10 (total of 27 pills)
Drug: Acyline
300 ug/kg injection on Day 0

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

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 Amory, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01167829     History of Changes
Other Study ID Numbers: 38636-D
Study First Received: July 20, 2010
Results First Received: September 25, 2012
Last Updated: August 23, 2013
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 April 17, 2014