Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia

August 22, 2016 updated by: Erdem Sahin, Kayseri Education and Research Hospital

The Effect of Metformin and Medroxyprogesterone Acetate on Apoptotic Signaling Pathways in Wistar-Albino Rats With Induced Endometrial Hyperplasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38000
        • Kayseri Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Medicated with only 4mg/kg 17β estradiol hemihydrate for 20 days to develop endometrial hyperplasia
Drug: 17β estradiol hemihydrate
4mg/kg/day for 20 days
Active Comparator: Metformin group
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 hemihydrate
4mg/kg/day for 20 days
Drug: Metformin
50 mg/kg/day last 10 days
Active Comparator: Medroxyprogesterone acetate group
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 hemihydrate
4mg/kg/day for 20 days
Drug: medroxyprogesterone acetate
1mg/kg/day last 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survivin Gene Expression Levels in Rat Uterine Tissue
Time Frame: 4 months
4 months
Bcl-2 Gene Expression Levels in Rat Uterine Tissue
Time Frame: 4 months
4 months
Bax Gene Expression Levels in Rat Uterine Tissue
Time Frame: 4 months
4 months
c-Myc Gene Expression Levels in Rat Uterine Tissue
Time Frame: 4 months
4 months
Caspase-9 Expression Levels in Rat Uterine Tissue
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayseri Education and Research Hospital

Investigators

  • Study Director: Erdem SAHİN, Kayseri Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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