A Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (MK-0000-064)

February 12, 2015 updated by: Merck Sharp & Dohme LLC

A Randomized, Single-Blind, Placebo-Controlled, Single-dose, Parallel Design Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (FSR)

This is a study to evaluate the use of fractional synthetic rate as an early biomarker of muscle anabolism (muscle build-up).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Subject is weight stable over the past 3 months
  • Patient agrees to refrain from consumption of alcohol from 48 hours prior to entering the study
  • Subject agrees to follow the study restriction of no caffeine while on study
  • Patient agrees to following the meat-free controlled protein weight-maintaining diet
  • Patient is willing to avoid strenuous physical activity
  • Patient has been a nonsmoker for at least 6 months prior to study start

Exclusion Criteria:

  • Subject is currently a regular user of any illicit drugs
  • Subject has taken androgenic steroids in the previous 12 months
  • Subject has participated in sports events, resistance exercise training or heavy exercise in the previous month
  • Subject has prostate cancer
  • Subject has a history of cancer except basal-cell tumors
  • Subject has been diagnosed with HIV
  • Subject has been diagnosed with Hepatitis B or C
  • Subject uses certain anti-inflammatory drugs such as ibuprofen, arcoxia or celecoxib
  • Subject uses a blood anticoagulant, such as Coumadin (Warfarin) or high doses of aspirin
  • Subject is currently taking over the counter supplements such as "muscle builders" or "fat burners"
  • Subject has an allergy or hypersensitivity to intramuscular testosterone
  • Subject has sciatica
  • Subject has donated blood products or has had phlebotomy within 2 months of signing informed consent
  • Subject has undergone a surgical procedure within 1 month of signing informed consent
  • Subject is currently participating or has participated in a study with an investigational drug or device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Testosterone - 300 mg IM
Drug: Comparator: Testosterone 300 mg, intramuscular injection

Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.

Day 1 & 7 - Testosterone 300 mg, Intramuscular injection.
Active Comparator: B
Testosterone - 100 mg IM
Drug: Comparator: Testosterone 100 mg, Intramuscular injection

Day 1 & 7- Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.

Day 1 & 7 - Testosterone 100 mg, Intramuscular injection.
Placebo Comparator: C
Placebo - IM
Drug: Comparator: Placebo given by Intramuscular Injection

Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies.

Day 1 & 7 - Placebo given as intramuscular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone.
Time Frame: One week
One week

Secondary Outcome Measures

Outcome Measure
Time Frame
Variability in the muscle fractional synthetic rate measurements.
Time Frame: One week
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 31, 2008

First Submitted That Met QC Criteria

January 2, 2009

First Posted (Estimate)

January 5, 2009

Study Record Updates

Last Update Posted (Estimate)

February 13, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-064
  • 2008_604

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Muscle Anabolism

Clinical Trials on Comparator: Testosterone 300 mg, intramuscular injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe