Atypical Endometrial HyperplasiaPhase 2/3NCT04607252
Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia
A Phase 2/3 study testing Metformin plus Megestrol acetate and Megestrol Acetate in people with Atypical Endometrial Hyperplasia, run by Fudan University at 1 site in China.
Trial summary
To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Atypical Endometrial Hyperplasia
- What is being tested?
- Metformin plus Megestrol acetate and Megestrol Acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2021to 3 Jun 2021
- Phase
- Phase 2/3
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years old;
- pathologically diagnosed with AEH for the first time;
- desire to preserve their fertility;
- no signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS);
- no contraindication for metformin, megestrol acetate or pregnancy;
- no hormone or metformin treatment within 6 months before entering the trial;
- not pregnant when participating in the trial;
- willing to follow the trial arrangement after being fully informed of all the risks and inconveniences caused by the trial.
Who cannot join
- Patients who had one or more of the following conditions:
- allergy history or contraindications for megestrol acetate or metformin;
- pregnant when initiating the study;
- alcoholism, severe infection, severe chronical diseases (dysfunction of heart, liver, lung or kidney);
- high risk of thrombosis;
- recurrent AEH;
- endometrial cancer;
- other malignancy history.
Trial locations and contacts
1 site in 1 country.
China1 site
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Comparing Metformin Plus Megestrol Acetate with Megestrol Acetate Alone As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia
To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH).
Read the detailed description
Whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH) is still not clear. Our previous finding from subgroup analysis in a phase II randomized controlled trial showed that 39.6% of AEH patients in metformin plus megestrol acetate group achieved complete response, compared with 20.4% in group of megestrol acetate alone. This trial aim to fully testify the effect of metformin in fertility-sparing treatment for AEH patients with adequate sample size.
- Conditions
- Atypical Endometrial Hyperplasia
- Being tested
- Metformin plus Megestrol acetate, Megestrol Acetate
- Medical subject headings
- Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin plus Megestrol acetateDrug
metformin 1500mg, per day, oral; megestrol acetate 160mg per day, oral
Megestrol AcetateDrug
megestrol acetate 160mg per day, oral
| Study group | Role | What they receive |
|---|---|---|
| Metformin plus megestrol acetate | Experimental | Metformin 1500mg per day plus megestrol acetate 160mg per day. Receives: Drug: Metformin plus Megestrol acetate |
| Megestrol acetate | Active comparator | Megestrol acetate 160mg per day. Receives: Drug: Megestrol Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response within 16 weeks of treatment
reversion of AEH The reversion of AEH to proliferative or secretory endometrium
Measured: 16 weeks
Secondary outcomes (5)
Complete response within 32 weeks of treatment
The reversion of AEH to proliferative or secretory endometrium
Measured: 32 weeks
Adverse events
Adverse events during the treatment of metformin plus megestrol acetate or megestrol acetate alone
Measured: 32 weeks
2-year recurrence rate
recurrence rate within 2 years after the treatment
Measured: 2 years
2-year pregnancy rate
Pregnancy rate within 2 years after the treatment
Measured: 2 years
2-year live-birth rate
Live-birth rate within 2 years after the treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start11 Jan 2021
- Primary completion3 Jun 2021
- Study completion3 Jun 2021
Why it stopped: Our clinical trial NCT03241888 showed LNG-IUS had a better treatment efficacy than Megestrol Acetate (MA) alone. The median CR time for MA group, LNG-IUS group and MA plus LNG-IUS group was 7.0±0.3 months, 4.4±1.0 months and 5.7±1.2 months.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Endometrial HyperplasiaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Chen, Fudan University
- Investigators
- Xiaojun Chen, PHD, Principal investigator, Obstetrics & Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607252
- Sponsor's protocol ID
- V01 2020-10
- Status last verified
- Sep 2024
- First submitted
- 23 Oct 2020
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared with other researchers without patients' personal information after all the findings being published.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Metformin Plus Megestrol Acetate with Megestrol Acetate Alone As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia
- ClinicalTrials.gov ID
- NCT04607252
- Acronym / sponsor ID
- V01 2020-10
- Conditions
- Atypical Endometrial Hyperplasia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Our clinical trial NCT03241888 showed LNG-IUS had a better treatment efficacy than Megestrol Acetate (MA) alone. The median CR time for MA group, LNG-IUS group and MA plus LNG-IUS group was 7.0±0.3 months, 4.4±1.0 months and 5.7±1.2 months.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 29 Oct 2020 (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.
To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH).
Detailed description
Whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH) is still not clear. Our previous finding from subgroup analysis in a phase II randomized controlled trial showed that 39.6% of AEH patients in metformin plus megestrol acetate group achieved complete response, compared with 20.4% in group of megestrol acetate alone. This trial aim to fully testify the effect of metformin in fertility-sparing treatment for AEH patients with adequate sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin plus megestrol acetate | Experimental | Drug: Metformin plus Megestrol acetateMetformin 1500mg per day plus megestrol acetate 160mg per day. |
| Megestrol acetate | Active comparator | Drug: Megestrol AcetateMegestrol acetate 160mg per day. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18-45 years old;
- pathologically diagnosed with AEH for the first time;
- desire to preserve their fertility;
- no signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS);
- no contraindication for metformin, megestrol acetate or pregnancy;
Key exclusion criteria (8 listed)
- allergy history or contraindications for megestrol acetate or metformin;
- pregnant when initiating the study;
- alcoholism, severe infection, severe chronical diseases (dysfunction of heart, liver, lung or kidney);
- high risk of thrombosis;
- recurrent AEH;
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 plus Megestrol acetatemetformin 1500mg, per day, oral; megestrol acetate 160mg per day, oral | Drug | Metformin plus megestrol acetate |
| Megestrol Acetatemegestrol acetate 160mg per day, oral | Drug | Megestrol acetate |
Primary outcome
Complete response within 16 weeks of treatment
Time frame: 16 weeks
reversion of AEH The reversion of AEH to proliferative or secretory endometrium
5 secondary outcomes
Complete response within 32 weeks of treatment
Time frame: 32 weeks
Adverse events
Time frame: 32 weeks
2-year recurrence rate
Time frame: 2 years
2-year pregnancy rate
Time frame: 2 years
2-year live-birth rate
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Our clinical trial NCT03241888 showed LNG-IUS had a better treatment efficacy than Megestrol Acetate (MA) alone. The median CR time for MA group, LNG-IUS group and MA plus LNG-IUS group was 7.0±0.3 months, 4.4±1.0 months and 5.7±1.2 months.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No. Data will be shared with other researchers without patients' personal information after all the findings being published.
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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.
Xiaojun Chen, PHD principal investigator
Obstetrics & Gynecology Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Metformin plus Megestrol acetate and Megestrol Acetate in people with Atypical Endometrial Hyperplasia, run by Fudan University at 1 site in China.
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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 26 Sep 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 China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Our clinical trial NCT03241888 showed LNG-IUS had a better treatment efficacy than Megestrol Acetate (MA) alone. The median CR time for MA group, LNG-IUS group and MA plus LNG-IUS group was 7.0±0.3 months, 4.4±1.0 months and 5.7±1.2 months.). Results are not available in the source record.
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?
Complete response within 16 weeks of treatment (time frame: 16 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 26 Sep 2024.