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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2010 by University of Washington.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by:

University of Washington

ClinicalTrials.gov Identifier:

NCT01167829

First received: July 20, 2010

Last updated: October 27, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 20, 2010

Last Updated Date

October 27, 2010

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01167829 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

ORAL T-8 Oral Testosterone for Male Hormonal Contraception

Official Title ^ICMJE

Pharmacokinetics of Modified Slow-Release Oral Testosterone Over 10 Days in Normal Men With Experimental Hypogonadism

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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)

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2011

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01167829

Other Study ID Numbers ^ICMJE

38636-D

Has Data Monitoring Committee

Responsible Party

John K. Amory, MD, University of Washington, Dept. of Medicine

Study Sponsor ^ICMJE

University of Washington

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

John K Amory, MD

University of Washington

Information Provided By

University of Washington

Verification Date

October 2010

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

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