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CompletedNCT01011725Updated Aug 10, 2016

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

A Phase 1 interventional study of MK 0773 and Placebo in Osteoporosis, sponsored by Merck Sharp & Dohme LLC. Completed. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-10.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Osteoporosis

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03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 67 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    Postmenopausal Women- Active Agent Group

    Drug: MK 0773

  • Placebo comparator
    Postmenopausal Women- Placebo

    Placebo

    Drug: Placebo

Interventions

  • DrugMK 0773

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

  • DrugPlacebo

    Placebo oral tablet b.i.d for 12 weeks

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01011725
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Nov 11, 2009
Start date
Nov 2005
Primary completion
Apr 2006
Completion
Mar 2009
Last update
Aug 10, 2016

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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