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

This study has been completed.
Information provided by (Responsible Party):
John Amory, University of Washington Identifier:
First received: July 20, 2010
Last updated: August 23, 2013
Last verified: August 2013
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: 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

Resource links provided by NLM:

Further study details as provided by John Amory, University of Washington:

Primary Outcome Measures:
  • 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

  • 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:
  • Maximum Dihydrotestosterone (DHT) Concentration [ Time Frame: baseline & day 9 ]
  • Mean Dihydrotestosterone (DHT) Concentration [ Time Frame: baseline & day 9 ]
  • Maximum Sex Hormone-Binding Globulin (SHGB)Concentration [ Time Frame: baseline & day 9 ]
  • Mean SHGB Concentration [ Time Frame: baseline & day 9 ]
  • Maximum Estradiol Concentration [ Time Frame: baseline & day 9 ]
  • Mean Estradiol Concentration [ Time Frame: baseline & day 9 ]
  • Free T Maximum Concentration [ Time Frame: baseline & day 9 ]
    Free T normal range 4.7-18 ng/dL

  • Free Testosterone Mean Concentration [ Time Frame: baseline & day 9 ]
    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.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes


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


  • 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
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 identifier: NCT01167829

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

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 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

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

Additional relevant MeSH terms:
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on August 17, 2017