Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women

This study has been completed.

Sponsor:

Information provided by:

Merck

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:

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

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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

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 May 23, 2013