Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02872818
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
Erdem Sahin, 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.

Condition or disease Intervention/treatment Phase
Apoptotic Signal Pathways in Endometrial Hyperplasia Drug: 17β estradiol hemihydrate Drug: Metformin Drug: medroxyprogesterone acetate Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Metformin and Medroxyprogesterone Acetate on Apoptotic Signaling Pathways in Wistar-Albino Rats With Induced Endometrial Hyperplasia
Study Start Date : October 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


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




Primary Outcome Measures :
  1. Survivin Gene Expression Levels in Rat Uterine Tissue [ Time Frame: 4 months ]
  2. Bcl-2 Gene Expression Levels in Rat Uterine Tissue [ Time Frame: 4 months ]
  3. Bax Gene Expression Levels in Rat Uterine Tissue [ Time Frame: 4 months ]
  4. c-Myc Gene Expression Levels in Rat Uterine Tissue [ Time Frame: 4 months ]
  5. Caspase-9 Expression Levels in Rat Uterine Tissue [ Time Frame: 4 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Weeks to 10 Weeks   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872818


Locations
Layout table for location information
Turkey
Kayseri Training and Research Hospital
Kayseri, Turkey, 38000
Sponsors and Collaborators
Kayseri Education and Research Hospital
Investigators
Layout table for investigator information
Study Director: Erdem SAHİN Kayseri Training and Research Hospital

Layout table for additonal information
Responsible Party: Erdem Sahin, Principal Investigator, Kayseri Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02872818     History of Changes
Other Study ID Numbers: 14/128
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016

Keywords provided by Erdem Sahin, Kayseri Education and Research Hospital:
Apoptotic signal pathway
Survivin
Bcl-2
Bax
c-Myc
Caspase-9
endometrial hyperplasia
endometrium cancer

Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperplasia
Endometrial Hyperplasia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Metformin
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Medroxyprogesterone
Medroxyprogesterone Acetate
Hypoglycemic Agents
Physiological Effects of Drugs
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents