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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01167829
Recruitment Status : Completed
First Posted : July 22, 2010
Results First Posted : August 23, 2013
Last Update Posted : September 6, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
John Amory, University of Washington

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Oral Testosterone Drug: Acyline Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2010
Primary Completion Date : October 2010
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

  2. Mean Testosterone Concentration [ Time Frame: baseline & day 9 ]
    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 :
  1. Maximum Dihydrotestosterone (DHT) Concentration [ Time Frame: baseline & day 9 ]
  2. Mean Dihydrotestosterone (DHT) Concentration [ Time Frame: baseline & day 9 ]
  3. Maximum Sex Hormone-Binding Globulin (SHGB)Concentration [ Time Frame: baseline & day 9 ]
  4. Mean SHGB Concentration [ Time Frame: baseline & day 9 ]
  5. Maximum Estradiol Concentration [ Time Frame: baseline & day 9 ]
  6. Mean Estradiol Concentration [ Time Frame: baseline & day 9 ]
  7. Free T Maximum Concentration [ Time Frame: baseline & day 9 ]
    Free T normal range 4.7-18 ng/dL

  8. Free Testosterone Mean Concentration [ Time Frame: baseline & day 9 ]
    Free T normal range 4.7-18 ng/dL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 22, 2010    Key Record Dates
Results First Posted: August 23, 2013
Last Update Posted: September 6, 2013
Last Verified: August 2013

Keywords provided by John Amory, 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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents