Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01011725
First received: November 10, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic efficacy of MK0773 in healthy postmenopausal women.


Condition Intervention Phase
Body Composition
Drug: MK0773
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Efficacy of MK0773 in Healthy Postmenopausal Women

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of subjects with Clinical Adverse Events (CAE) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with Serious CAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with drug-related CAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with serious drug-related CAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects that discontinued with CAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with Laboratory Adverse Events (LAE) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with drug-related LAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with serious LAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects with serious drug-related LAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of subjects that discontinued with LAEs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: November 2005
Study Completion Date: March 2009
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0773
Drug: MK0773
25 mg oral tablet b.i.d. MK0773 or 100 mg oral tablet b.i.d. MK0773, for 12 weeks
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo oral tablet b.i.d for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is a nonsurgical postmenopausal female
  • Subject is neither grossly overweight nor underweight for her height
  • Subject is in good health
  • Subject is willing to avoid excess alcohol and strenuous physical activity during the study
  • Subject agrees to refrain from consuming St. John's Wort, grapefruit or grapefruit juice during the study

Exclusion Criteria:

  • Subject has significant drug allergies
  • Subject has donated blood or 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011725

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT01011725     History of Changes
Other Study ID Numbers: 2009_687, MK0773-003
Study First Received: November 10, 2009
Last Updated: November 10, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 21, 2014