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

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ClinicalTrials.gov Identifier: NCT01011725
Recruitment Status : Completed
First Posted : November 11, 2009
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: MK 0773 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: Postmenopausal Women- Active Agent Group Drug: MK 0773
25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks
Placebo Comparator: Postmenopausal Women- Placebo
Placebo
Drug: Placebo
Placebo oral tablet b.i.d for 12 weeks



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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

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): NCT01011725


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01011725     History of Changes
Other Study ID Numbers: 0773-003
MK0773-003
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases