FemalePhase 3NCT05292573
Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia
A Phase 3 study testing Metformin in people with Female and Endometrial Hyperplasia Without Atypia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study will prospectively enroll a total of 1000 patients (200 per year) simple hyperplasia/complex hyperplasia (SH/CH) without atypia. All subjects will receive education for exercise and weight control and be randomized 1:1 to with or without metformin intervention. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Female, Endometrial Hyperplasia Without Atypia
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2018to 29 Jan 2026
- Phase
- Phase 3
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≧ 20 years
- Histological diagnosis of SH/CH without atypia
- Not taking Metformin for diabetes mellitus currently
- Adequate kidney function
- Provided informed consent within 3 months of diagnosis
- No previous history of breast cancer with tamoxifen use
- Willing to be followed for 5 years
Who cannot join
- Atypical hyperplasia or EC found within 3 months after enrollment
- History or concurrent gynecologic cancers or cervical intraepithelial neoplasia
- Pregnancy test positive
- History of intolerance to Metformin
- Family history of HNPCC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MicroRNAs as Biomarkers of Predicting Future Endometrial Malignancy and Longitudinal Follow-up With Randomized Intervention in Women With Endometrial Hyperplasia Without Atypia
This study will prospectively enroll a total of 1000 patients (200 per year) simple hyperplasia/complex hyperplasia (SH/CH) without atypia. All subjects will receive education for exercise and weight control and be randomized 1:1 to with or without metformin intervention. At the end of this 3-year project, an interim analysis will be performed. Since long-term follow-up is intended, therefore for the 4th to 6th year a new grant support will be looked for. The long-term occurrence of endometrial cancer (up to15 years) data will be acquired from national cancer registry, which permission is addressed in the informed sent.
Read the detailed description
The first year: (1) the cumulative progression rate of SH/CH without atypia to endometrial cancer (EC) of the 1989-2011 cohort will be investigated by linking with national health databases from Health and Welfare Data Science Center (HWDC); (2) Prospectively enroll 200 patients with SH/CH without atypia and deliver education for exercise and weight control and collect the related biospecimens and data; (3) 1:1 randomized to with or without metformin intervention.
The 2nd year: (1) analyze the whole genome sequencing (WGS) data of those progressed and non-progressed ; (2) analyze the metabolomic data in relation to exercise and weight control data.
The 3rd year: (1) validate microRNA (miR) panel in tissues and sera selected by CMRPG3G1511-3; (2) analyze data of MiR panel, degree of exercise/weight control, clinical lab data, and demographic data on EC progression rate; (3) Incremental predicting proficiency of the model including metabolomics data and WGS.
- Conditions
- Female, Endometrial Hyperplasia Without Atypia
- Being tested
- Metformin
- Keywords
- simple hyperplasia, Metformain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Uformin Tablet 500mg
During the intervention period, metformin is given 500 mg tablet b.i.d. Those who stopped taking metformin will remain in the study not counting as protocol violation.
| Study group | Role | What they receive |
|---|---|---|
| metformin group | Experimental | 1. During the intervention period, metformin is given 500 mg tablet b.i.d.
2. We will deliver education for exercise and weight control to all eligible participants Receives: Drug: Metformin |
| Observation group | No intervention | only exercise and weight control to all eligible participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the receiver operating characteristic curve (ROC curve) (AUC) of the prediction miR panel of the 4 miRs.
The primary endpoint of the randomized prospective study is to evaluate the ROC of the prediction miR panel of the 4 miRs.
Measured: 5 years
Secondary outcomes (2)
Time to progression among groups
Incidence of endometrial hyperplasia recurrence or progression to atypical hyperplasia/endometrial cancer among groups, Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Measured: 3 years
Subgroup analysis in body-weight control
Follow up the body-weight control
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Aug 2018
- Primary completion1 Oct 2022
- Study completion29 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FemaleStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292573
- Sponsor's protocol ID
- 107-2314-B-182A-166-MY3
- Status last verified
- Jul 2021
- First submitted
- 4 Aug 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified IPD are available under restricted access and can be obtained by contacting Chyong-Huey Lai (sh46erry@ms6.hinet.net).
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNAs as Biomarkers of Predicting Future Endometrial Malignancy and Longitudinal Follow-up With Randomized Intervention in Women With Endometrial Hyperplasia Without Atypia
- ClinicalTrials.gov ID
- NCT05292573
- Acronym / sponsor ID
- 107-2314-B-182A-166-MY3
- Conditions
- Female, Endometrial Hyperplasia Without Atypia
- Keywords
- simple hyperplasia, Metformain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 23 Mar 2022 (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.
This study will prospectively enroll a total of 1000 patients (200 per year) simple hyperplasia/complex hyperplasia (SH/CH) without atypia. All subjects will receive education for exercise and weight control and be randomized 1:1 to with or without metformin intervention. At the end of this 3-year project, an interim analysis will be performed. Since long-term follow-up is intended, therefore for the 4th to 6th year a new grant support will be looked for. The long-term occurrence of endometrial cancer (up to15 years) data will be acquired from national cancer registry, which permission is addressed in the informed sent.
Detailed description
The first year: (1) the cumulative progression rate of SH/CH without atypia to endometrial cancer (EC) of the 1989-2011 cohort will be investigated by linking with national health databases from Health and Welfare Data Science Center (HWDC); (2) Prospectively enroll 200 patients with SH/CH without atypia and deliver education for exercise and weight control and collect the related biospecimens and data; (3) 1:1 randomized to with or without metformin intervention.
The 2nd year: (1) analyze the whole genome sequencing (WGS) data of those progressed and non-progressed ; (2) analyze the metabolomic data in relation to exercise and weight control data.
The 3rd year: (1) validate microRNA (miR) panel in tissues and sera selected by CMRPG3G1511-3; (2) analyze data of MiR panel, degree of exercise/weight control, clinical lab data, and demographic data on EC progression rate; (3) Incremental predicting proficiency of the model including metabolomics data and WGS.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin group | Experimental | Drug: Metformin1. During the intervention period, metformin is given 500 mg tablet b.i.d. 2. We will deliver education for exercise and weight control to all eligible participants |
| Observation group | No intervention | –only exercise and weight control to all eligible participants |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged ≧ 20 years
- Histological diagnosis of SH/CH without atypia
- Not taking Metformin for diabetes mellitus currently
- Adequate kidney function
- Provided informed consent within 3 months of diagnosis
Key exclusion criteria (5 listed)
- Atypical hyperplasia or EC found within 3 months after enrollment
- History or concurrent gynecologic cancers or cervical intraepithelial neoplasia
- Pregnancy test positive
- History of intolerance to Metformin
- Family history of HNPCC
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 |
|---|---|---|
| MetforminAlso: Uformin Tablet 500mgDuring the intervention period, metformin is given 500 mg tablet b.i.d. Those who stopped taking metformin will remain in the study not counting as protocol violation. | Drug | metformin group |
Primary outcome
The area under the receiver operating characteristic curve (ROC curve) (AUC) of the prediction miR panel of the 4 miRs.
Time frame: 5 years
The primary endpoint of the randomized prospective study is to evaluate the ROC of the prediction miR panel of the 4 miRs.
2 secondary outcomes
Time to progression among groups
Time frame: 3 years
Subgroup analysis in body-weight control
Time frame: 3 years
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 8 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified IPD are available under restricted access and can be obtained by contacting Chyong-Huey Lai (sh46erry@ms6.hinet.net).
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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 Phase 3 study testing Metformin in people with Female and Endometrial Hyperplasia Without Atypia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 7 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 8 Oct 2026. 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 Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The area under the receiver operating characteristic curve (ROC curve) (AUC) of the prediction miR panel of the 4 miRs. (time frame: 5 years). 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 8 Oct 2026.