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Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia

Primary Purpose

Apoptotic Signal Pathways in Endometrial Hyperplasia

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
17β estradiol hemihydrate
Metformin
medroxyprogesterone acetate
Sponsored by
Kayseri Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apoptotic Signal Pathways in Endometrial Hyperplasia focused on measuring Apoptotic signal pathway, Survivin, Bcl-2, Bax, c-Myc, Caspase-9, endometrial hyperplasia, endometrium cancer

Eligibility Criteria

8 Weeks - 10 Weeks (Child)FemaleDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria.

We have no exclusion criteria because we examine drugs effects in the experimental rats

Sites / Locations

  • Kayseri Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control group

Metformin group

Medroxyprogesterone acetate group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Survivin Gene Expression Levels in Rat Uterine Tissue
Bcl-2 Gene Expression Levels in Rat Uterine Tissue
Bax Gene Expression Levels in Rat Uterine Tissue
c-Myc Gene Expression Levels in Rat Uterine Tissue
Caspase-9 Expression Levels in Rat Uterine Tissue

Secondary Outcome Measures

Full Information

First Posted
August 16, 2016
Last Updated
August 22, 2016
Sponsor
Kayseri Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02872818
Brief Title
Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia
Official Title
The Effect of Metformin and Medroxyprogesterone Acetate on Apoptotic Signaling Pathways in Wistar-Albino Rats With Induced Endometrial Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kayseri Education and Research Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apoptotic Signal Pathways in Endometrial Hyperplasia
Keywords
Apoptotic signal pathway, Survivin, Bcl-2, Bax, c-Myc, Caspase-9, endometrial hyperplasia, endometrium cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Medicated with only 4mg/kg 17β estradiol hemihydrate for 20 days to develop endometrial hyperplasia
Arm Title
Metformin group
Arm Type
Active Comparator
Arm Description
Having been obtained hyperplasia, the investigators continued medication with 50 mg/kg metformin in addition to 17β estradiol hemihydrate for 10 days
Arm Title
Medroxyprogesterone acetate group
Arm Type
Active Comparator
Arm Description
Having been obtained hyperplasia, the investigators continued medication with 1mg/day medroxyprogesterone acetate in addition to 17β estradiol hemihydrate for 10 days
Intervention Type
Drug
Intervention Name(s)
17β estradiol hemihydrate
Intervention Description
4mg/kg/day for 20 days
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
50 mg/kg/day last 10 days
Intervention Type
Drug
Intervention Name(s)
medroxyprogesterone acetate
Intervention Description
1mg/kg/day last 10 days
Primary Outcome Measure Information:
Title
Survivin Gene Expression Levels in Rat Uterine Tissue
Time Frame
4 months
Title
Bcl-2 Gene Expression Levels in Rat Uterine Tissue
Time Frame
4 months
Title
Bax Gene Expression Levels in Rat Uterine Tissue
Time Frame
4 months
Title
c-Myc Gene Expression Levels in Rat Uterine Tissue
Time Frame
4 months
Title
Caspase-9 Expression Levels in Rat Uterine Tissue
Time Frame
4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
8 Weeks
Maximum Age & Unit of Time
10 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Forty-eight weeks old female Wistar-Albino rats, weighting between 180 and 260 g Exclusion criteria. We have no exclusion criteria because we examine drugs effects in the experimental rats
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erdem SAHİN
Organizational Affiliation
Kayseri Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Kayseri Training and Research Hospital
City
Kayseri
ZIP/Postal Code
38000
Country
Turkey

12. IPD Sharing Statement

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Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia

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