Skip to main content
OpenTrials
Completed

NCT Number: NCT01011725

Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK 0773

Drug

25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks

Placebo

Drug

Placebo oral tablet b.i.d for 12 weeks

Primary outcomes

  1. Number of Participants with Serious Clinical Adverse Events

    Time frame: From date of enrollment through 12 weeks of study

  2. Number of Participants with Nonerserious Clinical Adverse Events

    Time frame: From date of enrollment through 12 weeks of study

  3. Number of Participants with Serious Laboratory Adverse Events

    Time frame: From date of enrollment through 12 weeks of study

  4. Number of Participants with Nonserious Laboratory Adverse Events

    Time frame: From date of enrollment through 12 weeks of study

  5. Number of Participants Who Discontinued Due to Any Adverse Event

    Time frame: From date of enrollment through 12 weeks of study

  6. Number of Participants Who Withdrew Consent and Discontinued the Study

    Time frame: From date of enrollment through 12 weeks of study

  7. Least Squares Mean Change in Lean Body Mass

    Time frame: From baseline, at 12 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2009
First posted
Nov 11, 2009
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.