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Quality of Life With Arcoxia in Women With Dysmenorrhea (0663-094)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00380627
Recruitment Status : Completed
First Posted : September 26, 2006
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Description
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Brief Summary:
Allow gynecologists to gain experience with arcoxia for treatment of dysmenorrhea.

Condition or disease Intervention/treatment Phase
Pain Drug: MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 337 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quality of Life With Arcoxia in Women With Dysmenorrhea
Actual Study Start Date : September 1, 2005
Actual Primary Completion Date : January 31, 2006
Actual Study Completion Date : January 31, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Perception of menstrual pain, through the analog verbal scale during three days.

Secondary Outcome Measures :
  1. Quality of life measures during three days.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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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): NCT00380627


Sponsors and Collaborators
Organon and Co
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
More Information
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Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00380627    
Other Study ID Numbers: 0663-094
2006_035
First Posted: September 26, 2006    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action