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Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)

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ClinicalTrials.gov Identifier: NCT01017458
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0773 in healthy older men.

Condition or disease Intervention/treatment Phase
Healthy Drug: MK0773 Drug: Comparator: testosterone enanthate Drug: Comparator: placebo oral tablet Drug: Comparator: placebo injection Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Endpoints of MK0773 in Healthy Older Men
Study Start Date : June 2007
Primary Completion Date : August 2008
Study Completion Date : August 2008


Arms and Interventions

Arm Intervention/treatment
Experimental: 1
MK0773 + placebo injection
Drug: MK0773
Three 25mg oral tablets MK0773 bid, for 12 weeks
Drug: Comparator: placebo injection
placebo intramuscular injection q14d, for 12 weeks
Active Comparator: 2
placebo to MK0773 + testosterone injection
Drug: Comparator: testosterone enanthate
intramuscular injection 200mg testosterone enanthate q14d, for 12 weeks
Other Name: Delatestryl
Drug: Comparator: placebo oral tablet
placebo oral tablet bid, for 12 weeks
Placebo Comparator: 3
placebo to MK0773 + placebo injection
Drug: Comparator: placebo oral tablet
placebo oral tablet bid, for 12 weeks
Drug: Comparator: placebo injection
placebo intramuscular injection q14d, for 12 weeks


Outcome Measures

Primary Outcome Measures :
  1. Number of subjects with Clinical Adverse Events (CAE) [ Time Frame: 12 weeks ]
  2. Number of subjects with Serious CAEs [ Time Frame: 12 weeks ]
  3. Number of subjects with drug-related CAEs [ Time Frame: 12 weeks ]
  4. Number of subjects with serious drug-related CAEs [ Time Frame: 12 weeks ]
  5. Number of subjects that discontinued with CAEs [ Time Frame: 12 weeks ]
  6. Number of subjects with Laboratory Adverse Events (LAE) [ Time Frame: 12 weeks ]
  7. Number of subjects with drug-related LAEs [ Time Frame: 12 weeks ]
  8. Number of subjects with serious LAEs [ Time Frame: 12 weeks ]
  9. Number of subjects with serious drug-related LAEs [ Time Frame: 12 weeks ]
  10. Number of subjects that discontinued with LAEs [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is in good general health
  • Subject agrees to avoid excess alcohol and strenuous physical activity during the study
  • Subject who is sexually active with partners of reproductive potential agrees to use two forms of appropriate contraception during the study

Exclusion Criteria:

  • Subject has significant drug allergies
  • Subject has donated blood within the last 8 weeks or has taken an investigational drug in another clinical trial within the last 4 weeks
  • Subject is a regular user or past abuser of any illicit drug (including alcohol)
  • Subject drinks excessive amounts of caffeinated beverages
  • Subject has a history of cancer
  • Subject has a history of prostate or testicular surgery
Contacts and Locations

Information from the National Library of Medicine

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): NCT01017458


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01017458     History of Changes
Other Study ID Numbers: 0773-004
2009_693
MK-0773-004
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by Merck Sharp & Dohme Corp.:
Healthy Adults

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