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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Postmenopausal Women- Active Agent Group

Group Type EXPERIMENTAL

MK 0773

Intervention Type DRUG

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

Postmenopausal Women- Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral tablet b.i.d for 12 weeks

Interventions

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MK 0773

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

Intervention Type DRUG

Placebo

Placebo oral tablet b.i.d for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes