Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia

NCT ID: NCT02872818

Last Updated: 2016-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Apoptotic Signal Pathways in Endometrial Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

17β estradiol hemihydrate

Intervention Type DRUG

4mg/kg/day for 20 days

Metformin group

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

Group Type ACTIVE_COMPARATOR

17β estradiol hemihydrate

Intervention Type DRUG

4mg/kg/day for 20 days

Metformin

Intervention Type DRUG

50 mg/kg/day last 10 days

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

Group Type ACTIVE_COMPARATOR

17β estradiol hemihydrate

Intervention Type DRUG

4mg/kg/day for 20 days

medroxyprogesterone acetate

Intervention Type DRUG

1mg/kg/day last 10 days

Interventions

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17β estradiol hemihydrate

4mg/kg/day for 20 days

Intervention Type DRUG

Metformin

50 mg/kg/day last 10 days

Intervention Type DRUG

medroxyprogesterone acetate

1mg/kg/day last 10 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

8 Weeks

Maximum Eligible Age

10 Weeks

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kayseri Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Erdem Sahin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erdem SAHİN

Role: STUDY_DIRECTOR

Kayseri Training and Research Hospital

Locations

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Kayseri Training and Research Hospital

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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14/128

Identifier Type: -

Identifier Source: org_study_id

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