Endometrial HyperplasiaEarly Phase 1NCT01685762
Metformin for the Treatment of Endometrial Hyperplasia
A Early Phase 1 study testing Metformin in people with Endometrial Hyperplasia and Endometrial Hyperplasia Without Atypia, run by UNC Lineberger Comprehensive Cancer Center at 3 sites in United States.
Trial summary
The purpose of this study is to see if metformin will be effective in making endometrial hyperplasia without atypia better by returning the tissue to a normal state. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Endometrial Hyperplasia, 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
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Jan 2013to 1 Dec 2015
- Phase
- Early Phase 1
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between the ages of 18-75 years old
- Have a confirmed diagnosis of endometrial hyperplasia without atypia based upon endometrial biopsy
- Have no contraindications to short-term metformin therapy
- Have a creatinine clearance of ≥ 90 ml/min, as calculated by the Cockroft-Gault formula
- Have normal serum transaminase values (AST and ALT)
- Need to be able to undergo metformin treatment for a duration of 12 weeks prior to repeat endometrial biopsy
Who cannot join
- Are currently taking metformin or have taken metformin in the past 6 months or have a history of an allergic reaction or intolerance at any time to metformin
- Have a history of liver or renal dysfunction.
- Have a random glucose of ≤ 65 or ≥ 200
- Have a recent history of alcoholism. Former alcoholics who have abstained from alcohol for 5 years or more may be enrolled in this study.
- Have a history of vitamin B12 deficiency
- Are pregnant
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- Are currently taking insulin
- Are taking a drug that may significantly interact or influence the metabolism of metformin
- In the opinion of the investigator, the patient is felt not to be appropriate for the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Southern Pines Women's Health Center
Southern Pines, North Carolina, 28388
About this study
The purpose of this study is to see if metformin will be effective in making endometrial hyperplasia without atypia better by returning the tissue to a normal state.
Read the detailed description
This is a multi-institutional pilot clinical trial designed to estimate the response rate and safety of metformin for the treatment of simple and complex endometrial hyperplasia (EH) without atypia. Enrollment of patients will occur at UNC-Chapel Hill and Southern Pines Women's Health Center. Fifteen patients will be enrolled over the course of 1 year. Metformin will be initiated at 850 mg orally once daily, and titrated up to twice daily over a minimum of 1 months time. Treatment will last 12 weeks and then patients will undergo repeat endometrial biopsy to assess for regression or persistence of EH.
- Being tested
- Metformin
- Keywords
- Endometrial hyperplasia, Uterus, Pilot, Metformin
- Medical subject headings
- Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Fortamet, Glucophage, Glumetza, Riomet
850 mg of metformin taken once daily by mouth for 4 weeks (weeks 1-4) and then twice daily by mouth for 8 weeks (weeks 5-12).
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Metformin once daily for 4 weeks (weeks 1-4) and then twice daily for 8 weeks (weeks 5-12). Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.
Measured: 12 weeks
Secondary outcomes (3)
Toxicity evaluation
Number of subjects who experience side effects
Measured: 12 weeks
Patient Compliance
Percentage of patients successfully completing metformin therapy.
Measured: 12 weeks
Potential molecular markers in response to treatment with Metformin
Compare changes in potential biomarkers, including metabolic factors and molecular markers of downstream targets of the metformin/mTOR signaling pathway, before and after metformin treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study start10 Jan 2013
- Primary completion1 Dec 2015
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial HyperplasiaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria Bae-Jump, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685762
- Sponsor's protocol ID
- LCCC 1205
- Status last verified
- Jan 2019
- First submitted
- 26 Jul 2012
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin for the Treatment of Endometrial Hyperplasia
- ClinicalTrials.gov ID
- NCT01685762
- Acronym / sponsor ID
- LCCC 1205
- Keywords
- Endometrial hyperplasia, Uterus, Pilot, Metformin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 10 Jan 2013 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 14 Sep 2012 (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 this study is to see if metformin will be effective in making endometrial hyperplasia without atypia better by returning the tissue to a normal state.
Detailed description
This is a multi-institutional pilot clinical trial designed to estimate the response rate and safety of metformin for the treatment of simple and complex endometrial hyperplasia (EH) without atypia. Enrollment of patients will occur at UNC-Chapel Hill and Southern Pines Women's Health Center. Fifteen patients will be enrolled over the course of 1 year. Metformin will be initiated at 850 mg orally once daily, and titrated up to twice daily over a minimum of 1 months time. Treatment will last 12 weeks and then patients will undergo repeat endometrial biopsy to assess for regression or persistence of EH.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminMetformin once daily for 4 weeks (weeks 1-4) and then twice daily for 8 weeks (weeks 5-12). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be between the ages of 18-75 years old
- Have a confirmed diagnosis of endometrial hyperplasia without atypia based upon endometrial biopsy
- Have no contraindications to short-term metformin therapy
- Have a creatinine clearance of ≥ 90 ml/min, as calculated by the Cockroft-Gault formula
- Have normal serum transaminase values (AST and ALT)
Key exclusion criteria (9 listed)
- Are currently taking metformin or have taken metformin in the past 6 months or have a history of an allergic reaction or intolerance at any time to metformin
- Have a history of liver or renal dysfunction.
- Have a random glucose of ≤ 65 or ≥ 200
- Have a recent history of alcoholism. Former alcoholics who have abstained from alcohol for 5 years or more may be enrolled in this study.
- Have a history of vitamin B12 deficiency
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: Fortamet, Glucophage, Glumetza, Riomet850 mg of metformin taken once daily by mouth for 4 weeks (weeks 1-4) and then twice daily by mouth for 8 weeks (weeks 5-12). | Drug | Metformin |
Primary outcome
Response Rate
Time frame: 12 weeks
Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies.
3 secondary outcomes
Toxicity evaluation
Time frame: 12 weeks
Patient Compliance
Time frame: 12 weeks
Potential molecular markers in response to treatment with Metformin
Time frame: 12 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 27 Apr 2025.
- UNC Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
Related trials for Endometrial Hyperplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
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Active, not recruitingPhase 2
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7
RecruitingObservational study
Liquid Biopsy-Based Early Screening for Endometrial Cancer in Regional Chinese Populations
Endometrial Cancer, Atypical Endometrial Hyperplasia
Not yet recruitingPhase 2
Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer
Endometrioid Endometrial Cancer, Atypical Endometrial Hyperplasia
RecruitingPhase 2
A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
Endometrioid Endometrial Adenocarcinoma
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.
Victoria Bae-Jump, MD, PhD principal investigator
University of North Carolina, Chapel Hill
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metformin in people with Endometrial Hyperplasia and Endometrial Hyperplasia Without Atypia, run by UNC Lineberger Comprehensive Cancer Center at 3 sites in United States.
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 6 inclusion and 9 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Response Rate (time frame: 12 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 27 Apr 2025.