Apoptotic Signal Pathways in Endometrial HyperplasiaPhase 4NCT02872818
Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia
A Phase 4 study testing 17β estradiol hemihydrate, Metformin and medroxyprogesterone acetate in people with Apoptotic Signal Pathways in Endometrial Hyperplasia, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 8 to 10 weeks, women only
- Conditions the study is for
- Apoptotic Signal Pathways in Endometrial Hyperplasia
- What is being tested?
- 17β estradiol hemihydrate, Metformin and medroxyprogesterone acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2014to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 weeks
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Forty-eight weeks old female Wistar-Albino rats, weighting between 180 and 260 g
Who cannot join
- We have no exclusion criteria because we examine drugs effects in the experimental rats
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri Training and Research Hospital
Kayseri, 38000
About this study
Official title: 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.
- Being tested
- 17β estradiol hemihydrate, Metformin, medroxyprogesterone acetate
- Keywords
- Apoptotic signal pathway, Survivin, Bcl-2, Bax, c-Myc, Caspase-9, endometrial hyperplasia, endometrium cancer
- Medical subject headings
- Endometrial Hyperplasia, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17β estradiol hemihydrateDrug
4mg/kg/day for 20 days
MetforminDrug
50 mg/kg/day last 10 days
medroxyprogesterone acetateDrug
1mg/kg/day last 10 days
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Medicated with only 4mg/kg 17β estradiol hemihydrate for 20 days to develop endometrial hyperplasia Receives: Drug: 17β estradiol hemihydrate |
| Metformin group | Active comparator | Having been obtained hyperplasia, the investigators continued medication with 50 mg/kg metformin in addition to 17β estradiol hemihydrate for 10 days Receives: Drug: 17β estradiol hemihydrate; Drug: Metformin |
| Medroxyprogesterone acetate group | Active comparator | Having been obtained hyperplasia, the investigators continued medication with 1mg/day medroxyprogesterone acetate in addition to 17β estradiol hemihydrate for 10 days Receives: Drug: 17β estradiol hemihydrate; Drug: medroxyprogesterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivin Gene Expression Levels in Rat Uterine Tissue
Measured: 4 months
Bcl-2 Gene Expression Levels in Rat Uterine Tissue
Measured: 4 months
Bax Gene Expression Levels in Rat Uterine Tissue
Measured: 4 months
c-Myc Gene Expression Levels in Rat Uterine Tissue
Measured: 4 months
Caspase-9 Expression Levels in Rat Uterine Tissue
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apoptotic Signal Pathways in Endometrial HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erdem Sahin, Kayseri Education and Research Hospital
- Investigators
- Erdem SAHİN, Study director, Kayseri Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872818
- Sponsor's protocol ID
- 14/128
- Status last verified
- Aug 2016
- First submitted
- 16 Aug 2016
- Last updated
- 23 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Metformin and Medroxyprogesterone Acetate on Apoptotic Signaling Pathways in Wistar-Albino Rats With Induced Endometrial Hyperplasia
- ClinicalTrials.gov ID
- NCT02872818
- Acronym / sponsor ID
- 14/128
- Keywords
- Apoptotic signal pathway, Survivin, Bcl-2, Bax, c-Myc, Caspase-9, endometrial hyperplasia, endometrium cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: 17β estradiol hemihydrateMedicated with only 4mg/kg 17β estradiol hemihydrate for 20 days to develop endometrial hyperplasia |
| Metformin group | Active comparator | Drug: 17β estradiol hemihydrate, Drug: MetforminHaving been obtained hyperplasia, the investigators continued medication with 50 mg/kg metformin in addition to 17β estradiol hemihydrate for 10 days |
| Medroxyprogesterone acetate group | Active comparator | Drug: 17β estradiol hemihydrate, Drug: medroxyprogesterone acetateHaving been obtained hyperplasia, the investigators continued medication with 1mg/day medroxyprogesterone acetate in addition to 17β estradiol hemihydrate for 10 days |
Who may qualify
- Ages
- 8 to 10 weeks
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Forty-eight weeks old female Wistar-Albino rats, weighting between 180 and 260 g
Key exclusion criteria (1 listed)
- We have no exclusion criteria because we examine drugs effects in the experimental rats
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17β estradiol hemihydrate4mg/kg/day for 20 days | Drug | Control group, Medroxyprogesterone acetate group, Metformin group |
| Metformin50 mg/kg/day last 10 days | Drug | Metformin group |
| medroxyprogesterone acetate1mg/kg/day last 10 days | Drug | Medroxyprogesterone acetate group |
Primary outcome
Survivin Gene Expression Levels in Rat Uterine Tissue
Time frame: 4 months
Bcl-2 Gene Expression Levels in Rat Uterine Tissue
Time frame: 4 months
Bax Gene Expression Levels in Rat Uterine Tissue
Time frame: 4 months
c-Myc Gene Expression Levels in Rat Uterine Tissue
Time frame: 4 months
Caspase-9 Expression Levels in Rat Uterine Tissue
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erdem SAHİN study director
Kayseri Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 17β estradiol hemihydrate, Metformin and medroxyprogesterone acetate in people with Apoptotic Signal Pathways in Endometrial Hyperplasia, run by Kayseri Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivin Gene Expression Levels in Rat Uterine Tissue (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.