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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02872818
Other study ID # 14/128
Secondary ID
Status Completed
Phase Phase 4
First received August 16, 2016
Last updated August 22, 2016
Start date October 2014
Est. completion date March 2015

Study information

Verified date August 2016
Source Kayseri Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Female
Age group 8 Weeks to 10 Weeks
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
17ß estradiol hemihydrate
4mg/kg/day for 20 days
Metformin
50 mg/kg/day last 10 days
medroxyprogesterone acetate
1mg/kg/day last 10 days

Locations

Country Name City State
Turkey Kayseri Training and Research Hospital Kayseri

Sponsors (1)

Lead Sponsor Collaborator
Kayseri Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survivin Gene Expression Levels in Rat Uterine Tissue 4 months No
Primary Bcl-2 Gene Expression Levels in Rat Uterine Tissue 4 months No
Primary Bax Gene Expression Levels in Rat Uterine Tissue 4 months No
Primary c-Myc Gene Expression Levels in Rat Uterine Tissue 4 months No
Primary Caspase-9 Expression Levels in Rat Uterine Tissue 4 months No