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

July 20, 2010
August 23, 2013
July 2010
October 2010   (final data collection date for primary outcome measure)
  • 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
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.
Complete list of historical versions of study NCT01167829 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
ORAL T-8 Oral Testosterone for Male Hormonal Contraception
Pharmacokinetics of Modified Slow-Release Oral Testosterone Over 10 Days in Normal Men With Experimental Hypogonadism

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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Healthy
  • 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
Experimental: Acyline and oral testosterone
Interventions:
  • Drug: Oral Testosterone
  • Drug: Acyline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
June 2012
October 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01167829
38636-D
No
John Amory, University of Washington
University of Washington
GlaxoSmithKline
Principal Investigator: John K Amory, MD University of Washington
University of Washington
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP