Menorrhagia, Dysmenorrhea and Iron Deficiency Among Young... | NCT02685501

Studies
Menorrhagia, Dysmenorrhea and Iron Deficiency Among Young Women Soldiers and Effect on Activity

NCT02685501

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Feb 24, 2016Estimated

Enrollment

800Estimated

Phase

Not provided

Conditions

Menorrhagia
Dysmenorrhea
Iron Deficiency Anemia

Interventions

no intervention

Countries

Israel

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

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Dec 2016Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Feb 14, 2016

First Submission Date that Met QC Criteria

Feb 14, 2016

First Posted Date

Feb 18, 2016Estimated

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

Feb 23, 2016

Last Update Posted Date

Feb 24, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shoshana Vilk, Prof. Shoshana Revel-Villk, Hadassah Medical OrganizationPrincipal Investigator

Lead Sponsor

Hadassah Medical OrganizationOTHER

Collaborators

Not provided

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

As combat women soldiers are required to more intensive daily activity the investigators believe that the impact of menorrhagia, dysmenorrhea and its clinical consequence (as characterized by, anemia iron deficiency and reduced quality of life)) on personal performance will be more significant in combat women soldiers compared to non-combat women soldiers. Using cohorts from the same environment will enable the investigators to better study the effect of menorrhagia and dysmenorrhea eliminating other uncontrolled factors, such as nutrition. The study does not include any intervention.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Combat women soldiers		Women soldiers in combat units	Other: no intervention
Non combat women soldiers		Women soldiers in non-combat units	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other		Combat women soldiers Non combat women soldiers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Menorrhagia and dysmenorrhea	The prevalence of menorrhagia and dysmenorrhea and association with quality of life will be assessed	one year

Secondary Outcomes

Measure	Description	Time Frame
Iron deficiency	The prevalence of iron deficiency and iron deficiency anemia will be assessed by laboratory tests.	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women soldiers in the participating units

Exclusion Criteria:

Lack of consent

Accepts Healthy Volunteers

Yes

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

Women soldiers

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization	Recruiting	Jerusalem		91120	Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008595	Menorrhagia
D004412	Dysmenorrhea
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided