NCT02903797

Brief Summary

The purpose of the study is to determine serum irisin hormone levels an its relation between endometrial hyperplasia

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

September 13, 2016

Last Update Submit

September 13, 2016

Conditions

Keywords

Endometrial hyperplasiaIrisinfibronectin type III domain containing 5FNDC5 (fibronectin type III domain containing )

Outcome Measures

Primary Outcomes (1)

  • Serum irisin hormone levels in endometrial hyperplasia

    6 months

Study Arms (2)

Endometrial Hyperplasia

The first group was formed of the patients diagnosed endometrial hyperplasia histopathologically

Control group

The control group was formed of the patients who were healthy women admitted to the clinic just for annual examination without any complain and symptoms

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study consisted of two groups. The first group was formed of the patients diagnosed endometrial hyperplasia histopathologically, and the controls were healthy women admitted to the clinic just for annual examination without any complain and symptoms.

You may qualify if:

  • between 35-50 years of age
  • İn endometrial hyperplasia group; patients who were diagnosed endometrial hyperplasia histopathologically

You may not qualify if:

  • Pregnancy
  • Liver function disorders
  • Cardiovascular disease
  • Metabolic disease
  • Diabetes
  • Chronic kidney disease
  • Central nerves system disease
  • Immunosuppressive drug use
  • Another known malignancy
  • Excessive exercises in among one month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri Training and Research Hospital

Kayseri, 38000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Endometrial Hyperplasia

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Erdem SAHİN

    Kayseri Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erdem SAHİN, Principal İnvestigator

CONTACT

Yusuf MADENDAG, Contact Backup

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 16, 2016

Study Start

August 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

September 16, 2016

Record last verified: 2016-09

Locations