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

NCT ID: NCT00380627

Last Updated: 2024-08-15

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

PHASE4

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-01

Study Completion Date

2006-01-31

Brief Summary

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

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2006_035

Identifier Type: -

Identifier Source: secondary_id

0663-094

Identifier Type: -

Identifier Source: org_study_id

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