Quality of Life With Arcoxia in Women With Dysmenorrhea (... | NCT00380627

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

NCT00380627

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

337

Phase

Phase 4

Conditions

Pain

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006_035

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2005Actual

Primary Completion Date

Jan 31, 2006Actual

Completion Date

Jan 31, 2006Actual

First Submitted Date

Sep 22, 2006

First Submission Date that Met QC Criteria

Sep 22, 2006

First Posted Date

Sep 26, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2024

Last Update Posted Date

Aug 15, 2024Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

337

Name	Type	Description	Arm Group Labels	Other Names
MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perception of menstrual pain, through the analog verbal scale during three days.

Secondary Outcomes

Measure	Description	Time Frame
Quality of life measures during three days.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077613	Etoricoxib
D000081206	Duration of Therapy

Ancestor Terms

ID	Term
D013450	Sulfones
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines

Browse Leaves

Not provided

Browse Branches

Not provided