new long acting oral test?

[AZGOLDSMEMBER86]

GlaxoSmithKline GSK i guess is studieing this new long acting oral test.. any one else her of it? or the company?And has anyone taken test orally?I know you can just dont know what the difference is..

[Big]

what is it called?

[AZGOLDSMEMBER86]

what is it called?

not siure of the chemical name just know GSK is making it.. some kind of sustained release test...

[Big]

interesting

[AZGOLDSMEMBER86]

yeah, Id like to see how it comes out.

[boxin23]

I think this is what you are talking about. This is my college. Well not any more. They are doing the research.

Hope this helps.


ORAL T-8 Oral Testosterone for Male Hormonal Contraception (Oral T-8)
This study is currently recruiting participants.
Verified by University of Washington, July 2010
First Received: July 20, 2010 Last Updated: July 21, 2010 History of Changes
Sponsor: University of Washington
Collaborator: GlaxoSmithKline
Information provided by: University of Washington
ClinicalTrials.gov Identifier: NCT01167829
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: Acyline and Oral Testosterone
Phase I

Study Type: Interventional
Study Design: Control: Active Control
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:

MedlinePlus related topics: Birth Control
Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Acyline Oxymesterone Testosterone enanthate Testosterone undecanoate
U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
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.


Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
Drug: Acyline and Oral Testosterone
Acyline: 300 ug/kg injection on Day 0 Oral Testosterone: 300 mg, pills, three times daily Day 1 - 10 (total of 27 pills)
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 Recruiting
Seattle, Washington, United States, 98195
Contact: Iris Nielsen 206-221-5473 [email protected]
Contact: John K Amory, MD, MPH 206.616.1727 [email protected]
Principal Investigator: John Amory, MD, MPH
Sub-Investigator: Ada Lee, MD
Sub-Investigator: Mara Roth, MD
Sub-Investigator: Stephanie Page, MD, PhD
Sponsors and Collaborators
University of Washington
GlaxoSmithKline
More Information

No publications provided

Responsible Party: University of Washington, Dept. of Medicine ( John K. Amory, MD )
ClinicalTrials.gov Identifier: NCT01167829 History of Changes
Other Study ID Numbers: 38636
Study First Received: July 20, 2010
Last Updated: July 21, 2010
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 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

[boxin23]

Bump

[boxin23]

its gonna be called T-8

[boxin23]

And something interesting about this study is that it is open to adults from the ages of 18-55. Young!

[boxin23]

bump...anyone know about this?

[trix8]

Whats the liver toxicity on somthing like this, is it being meant for hrt paitents