NCT02872818

Brief Summary

The purpose of the study is to determine apoptotic signaling pathways such as Survivin, Bcl-2, Bax, c-Myc and caspase-9 expression levels in rats model with iatrogenic endometrial hyperplasia after metformin and medroxyprogesterone acetate administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

August 16, 2016

Last Update Submit

August 22, 2016

Conditions

Apoptotic Signal Pathways in Endometrial Hyperplasia

Keywords

Apoptotic signal pathwaySurvivinBcl-2Baxc-MycCaspase-9endometrial hyperplasiaendometrium cancer

Outcome Measures

Primary Outcomes (5)

  • Survivin Gene Expression Levels in Rat Uterine Tissue

    4 months

  • Bcl-2 Gene Expression Levels in Rat Uterine Tissue

    4 months

  • Bax Gene Expression Levels in Rat Uterine Tissue

    4 months

  • c-Myc Gene Expression Levels in Rat Uterine Tissue

    4 months

  • Caspase-9 Expression Levels in Rat Uterine Tissue

    4 months

Study Arms (3)

Control group

ACTIVE COMPARATOR

Medicated with only 4mg/kg 17β estradiol hemihydrate for 20 days to develop endometrial hyperplasia

Drug: 17β estradiol hemihydrate

Metformin group

ACTIVE COMPARATOR

Having been obtained hyperplasia, the investigators continued medication with 50 mg/kg metformin in addition to 17β estradiol hemihydrate for 10 days

Drug: 17β estradiol hemihydrateDrug: Metformin

Medroxyprogesterone acetate group

ACTIVE COMPARATOR

Having been obtained hyperplasia, the investigators continued medication with 1mg/day medroxyprogesterone acetate in addition to 17β estradiol hemihydrate for 10 days

Drug: 17β estradiol hemihydrateDrug: medroxyprogesterone acetate

Interventions

17β estradiol hemihydrateDRUG

4mg/kg/day for 20 days

Control groupMedroxyprogesterone acetate groupMetformin group
MetforminDRUG

50 mg/kg/day last 10 days

Metformin group
medroxyprogesterone acetateDRUG

1mg/kg/day last 10 days

Medroxyprogesterone acetate group

Eligibility Criteria

Age8 Weeks - 10 Weeks
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Forty-eight weeks old female Wistar-Albino rats, weighting between 180 and 260 g

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri Training and Research Hospital

Kayseri, 38000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometrial HyperplasiaEndometrial Neoplasms

Interventions

MetforminMedroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsMedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Erdem SAHİN

    Kayseri Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 23, 2016

Record last verified: 2016-08

Locations

TU(1)