ORAL T-8 Oral Testosterone for Male Hormonal Contraception (Oral T8)
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ClinicalTrials.gov Identifier: NCT01167829 |
Recruitment Status
:
Completed
First Posted
: July 22, 2010
Results First Posted
: August 23, 2013
Last Update Posted
: September 6, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Oral Testosterone Drug: Acyline | Phase 1 |
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 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | June 2012 |

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
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- 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
- 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

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

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
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | John K Amory, MD | University of Washington |
Publications:
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 |