Prevalence of Menstrual Cycle Related Pain Complains in A... | NCT00590811

Studies
Prevalence of Menstrual Cycle Related Pain Complains in Adolescents and Young Adults

NCT00590811

Sponsor

University Hospital, Gasthuisberg

Status

Completed

Last Update Posted

Sep 1, 2010Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Dysmenorrhea
Pelvic Pain

Interventions

Not provided

Countries

Belgium

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

Status Module

Record Verification Date

Jan 2010

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

Jan 2008

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Dec 31, 2007

First Submission Date that Met QC Criteria

Dec 31, 2007

First Posted Date

Jan 11, 2008Estimated

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 31, 2010

Last Update Posted Date

Sep 1, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to determine the prevalence of menstrual cycle related pain complains in adolescents and young adults.

Detailed Description

An internet questionnaire with 12 items was used:

Adolescents

start of menstruation
characteristics of menstrual cycle
pain related to menstrual cycle (questions based on well-known pain-complaints related to the presence of endometriosis)
analgetics
influence on school carrier
influence on social life

Young adults

idem as for adolescents
influence of pain on an eventual sexual relationship

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
adolescents		3rd year high school girls (14-16 years old)
young adults		1st year university young females (18 - 20 years old)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of menstrual cycle related pain complains		3rd year high school & first year university

Secondary Outcomes

Measure	Description	Time Frame
Relationship between level of pain complains and characteristics of menstrual cycle		3rd year high school & first year university

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

3rd year high school girls
1st year university young females

Exclusion Criteria:

pre-menarcheal girls

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

3rd year high school girls and 1st year university young females having a routine visit to the school doctor or student doctor.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christel LC Meuleman, MD	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MPTC		Leuven		3000	Belgium
VCLB

Condition Browse Module

MeSH Terms

ID	Term
D004412	Dysmenorrhea
D017699	Pelvic Pain

Ancestor Terms

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided