MetforminNCT03618472
Comparison of the Effectiveness Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells
A study testing Metformin Hydrochloride 850 MG in people with Metformin and CA Endometrium, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Comparison of the effectiveness metformin versus placebo for deceasing proliferative marker Ki-67 expression in endometrial tumours when given for 4 weeks before hysterectomy in endometrial cancer cells. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metformin, CA Endometrium
- What is being tested?
- Metformin Hydrochloride 850 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2018to 30 Jan 2020
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women with endometrial cancer who undergoing complete surgical staging and agrees to participate in this study
Who cannot join
- Women without diabetes type 1 and 2
- Women who have allergy Biguanide
- Women who have hypoglycemic medication
- Women who have GFR <45 ml/min/1.73 m2
- Women who have evidence of stage 3 or 4 of endometrial cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells : a Randomized Double Blind Placebo-controlled Trial
Comparison of the effectiveness metformin versus placebo for deceasing proliferative marker Ki-67 expression in endometrial tumours when given for 4 weeks before hysterectomy in endometrial cancer cells.
Read the detailed description
Endometrial cancer is one of the most common gynecological cancers. Preclinical studies in endometrial cancer (EC) show that metformin reduces cellular proliferation by PI3K-AKT-mTOR inhibition. The investigators tested the hypothesis that short-term presurgical metformin reduces cellular proliferation in endometrial cancer. However, no good quality of evidence base supports the effectiveness of metformin for deceasing proliferative marker in endometrial cancer.
- Conditions
- Metformin, CA Endometrium
- Being tested
- Metformin Hydrochloride 850 MG, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hydrochloride 850 MGDrug
Also called if any
Regular strength metformin (850 mg/tab)
Placebo Oral TabletDrug
Also called if any
Starch based placebo manufatured to mimic Metformin 850 mg
| Study group | Role | What they receive |
|---|---|---|
| metformin | Experimental | The participant will be eat metformin 850 mg 1 tab daily,4 weeks prior to hysterectomy Receives: Drug: Metformin Hydrochloride 850 MG |
| placebo | Placebo comparator | The participant will be eat placebo (same shape, size, color)1 tab daily ,4 weeks prior to hysterectomy Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Ki-67 expression in endometrial tumor
metformin administration reduced Ki-67 expression in endometrial tumor when given for 4 weeks before hysterectomy.
Measured: 4 weeks
Secondary outcomes (1)
Change of grade in endometrial tumor
metformin administration reduced grade in endometrial tumor when given for 4 weeks before hysterectomy.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Jul 2018
- Primary completion30 Nov 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetforminStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618472
- Sponsor's protocol ID
- Rjmetformin
- Status last verified
- Oct 2018
- First submitted
- 1 Aug 2018
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin for Deceasing Proliferative Marker in Endometrial Cancer Cells : a Randomized Double Blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03618472
- Acronym / sponsor ID
- Rjmetformin
- Conditions
- Metformin, CA Endometrium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 7 Aug 2018 (actual)
- 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.
Comparison of the effectiveness metformin versus placebo for deceasing proliferative marker Ki-67 expression in endometrial tumours when given for 4 weeks before hysterectomy in endometrial cancer cells.
Detailed description
Endometrial cancer is one of the most common gynecological cancers. Preclinical studies in endometrial cancer (EC) show that metformin reduces cellular proliferation by PI3K-AKT-mTOR inhibition. The investigators tested the hypothesis that short-term presurgical metformin reduces cellular proliferation in endometrial cancer. However, no good quality of evidence base supports the effectiveness of metformin for deceasing proliferative marker in endometrial cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin | Experimental | Drug: Metformin Hydrochloride 850 MGThe participant will be eat metformin 850 mg 1 tab daily,4 weeks prior to hysterectomy |
| placebo | Placebo comparator | Drug: Placebo Oral TabletThe participant will be eat placebo (same shape, size, color)1 tab daily ,4 weeks prior to hysterectomy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women with endometrial cancer who undergoing complete surgical staging and agrees to participate in this study
Key exclusion criteria (5 listed)
- Women without diabetes type 1 and 2
- Women who have allergy Biguanide
- Women who have hypoglycemic medication
- Women who have GFR <45 ml/min/1.73 m2
- Women who have evidence of stage 3 or 4 of endometrial cancer
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 |
|---|---|---|
| Metformin Hydrochloride 850 MGAlso: if anyRegular strength metformin (850 mg/tab) | Drug | metformin |
| Placebo Oral TabletAlso: if anyStarch based placebo manufatured to mimic Metformin 850 mg | Drug | placebo |
Primary outcome
Change of Ki-67 expression in endometrial tumor
Time frame: 4 weeks
metformin administration reduced Ki-67 expression in endometrial tumor when given for 4 weeks before hysterectomy.
1 secondary outcome
Change of grade in endometrial tumor
Time frame: 4 weeks
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 3 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin Hydrochloride 850 MG in people with Metformin and CA Endometrium, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 5 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 3 Dec 2024. 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change of Ki-67 expression in endometrial tumor (time frame: 4 weeks). 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 3 Dec 2024.