Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia

Phase 4

Completed

• Conditions: Apoptotic Signal Pathways in Endometrial Hyperplasia
• Interventions: Drug: 17β estradiol hemihydrate; Drug: Metformin; Drug: medroxyprogesterone acetate

• Registration Number: NCT02872818
• Lead Sponsor: Kayseri Education and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Last Update Submitted: 2016-08-22
• Last Update Posted: 2016-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	17β estradiol hemihydrate	Medicated with only 4mg/kg 17β estradiol hemihydrate for 20 days to develop endometrial hyperplasia
Metformin group	17β estradiol hemihydrate	Having been obtained hyperplasia, the investigators continued medication with 50 mg/kg metformin in addition to 17β estradiol hemihydrate for 10 days
Medroxyprogesterone acetate group	17β estradiol hemihydrate	Having been obtained hyperplasia, the investigators continued medication with 1mg/day medroxyprogesterone acetate in addition to 17β estradiol hemihydrate for 10 days
Metformin group	Metformin	Having been obtained hyperplasia, the investigators continued medication with 50 mg/kg metformin in addition to 17β estradiol hemihydrate for 10 days
Medroxyprogesterone acetate group	medroxyprogesterone acetate	Having been obtained hyperplasia, the investigators continued medication with 1mg/day medroxyprogesterone acetate in addition to 17β estradiol hemihydrate for 10 days

Primary Outcome Measures

Name	Time	Method
c-Myc Gene Expression Levels in Rat Uterine Tissue	4 months
Caspase-9 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
Survivin Gene Expression Levels in Rat Uterine Tissue	4 months

Trial Locations

Locations (1)

Kayseri Training and Research Hospital; 🇹🇷 Kayseri, Turkey