NCT00380627

Brief Summary

Allow gynecologists to gain experience with arcoxia for treatment of dysmenorrhea.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
337

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_4 pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2006

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

September 22, 2006

Last Update Submit

August 12, 2024

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Perception of menstrual pain, through the analog verbal scale during three days.

Secondary Outcomes (1)

  • Quality of life measures during three days.

Interventions

MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 DaysDRUG

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women older than 18 years old and younger than 25 years old
  • Voluntary agreement to participate in the study and signature of informed consent
  • Women with clinical diagnosis of dysmenorrhea

You may not qualify if:

  • Diagnosis of secondary dysmenorrhea due to: endometriosis, adenomyosis, malformations of Muller's conducts, uterine fibromyomas, ovarian cystic, pelvic varicocoele, inflammatory pelvic disease, adherences, intrauterine devices, cervical channel stenosis, etc.
  • Patients with diagnosis of acute inflammatory abdomen
  • Patients with diagnosis of congestive heart disease, stroke (1 year), unstable angina, and history of myocardial infarction
  • Women auto prescribing rescue medication for dysmenorrheal pain during the study
  • Women with a diagnosis of mild dysmenorrhea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

EtoricoxibDuration of Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2006

First Posted

September 26, 2006

Study Start

September 1, 2005

Primary Completion

January 31, 2006

Study Completion

January 31, 2006

Last Updated

August 15, 2024

Record last verified: 2022-02