Endometrioid Endometrial CancerPhase 2NCT07890064
Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer
A Phase 2 study testing LNG-IUS: levonorgestrel intrauterine system, Metformin and Canagliflozin in people with Endometrioid Endometrial Cancer and Atypical Endometrial Hyperplasia, run by Wang Yingmei at 1 site in China.
Trial summary
This study aims to evaluate whether the addition of canagliflozin to levonorgestrel-releasing intrauterine system (LNG-IUS) treatment, as compared with matching placebo or with the addition of metformin, increases the rate of pathological complete response (CR) at Week 24 in patients who wish to preserve fertility and… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometrioid Endometrial Cancer, Atypical Endometrial Hyperplasia
- What is being tested?
- LNG-IUS: levonorgestrel intrauterine system, Metformin and Canagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 31 Dec 2031
- Phase
- Phase 2
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
- Female, aged 18-45 years, with a definite desire for fertility preservation
- First-time diagnosis of atypical endometrial hyperplasia (AH) or grade 1 endometrioid endometrial carcinoma (G1 EEC), confirmed by pathologists at the study center
- For patients with EEC, MRI or ultrasound confirming that the lesion is confined to the endometrium or invades less than 1/2 of the myometrium, without distant metastasis
- Positive expression of both estrogen receptor (ER) and progesterone receptor (PR)
- Normal hepatic and renal function
- No contraindications to progestin or canagliflozin therapy
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- No hormonal therapy or SGLT2 inhibitor treatment lasting more than 1 month within the previous 6 months
- Presence of any of the following: diagnosed polycystic ovary syndrome (PCOS), overweight (BMI ≥ 24), impaired glucose tolerance, or diabetes mellitus
- No other fertility disorders and no contraindications to pregnancy
- Not currently pregnant
- Good compliance, willing to comply with subsequent assessments, treatment, and follow-up, with understanding and signing of the informed consent form
Who cannot join
- History of allergy to LNG-IUS, SGLT2 inhibitors, or metformin, or any contraindication to these treatments;
- Overly large uterine cavity (mean diameter > 7 cm) or a history of LNG-IUS (Mirena) expulsion;
- Type 2 diabetes mellitus requiring insulin therapy, or glycated hemoglobin (HbA1c) > 8.5% (insulin users are excluded owing to the increased risk of ketoacidosis);
- History of type 1 diabetes mellitus, diabetic ketoacidosis, peripheral vascular disease, or diabetic foot ulcers;
- Long-term use of corticosteroids or insulin/insulin sensitizers;
- Baseline blood pressure below 90/60 mmHg;
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- Severe chronic diseases with cardiac, hepatic, pulmonary, or renal insufficiency (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 × the upper limit of normal [ULN], or serum bilirubin > 3 × ULN), or renal insufficiency (estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m²);
- Active infection, or a history of recurrent urinary tract infections (≥ 3 episodes within the previous 12 months, or ≥ 2 episodes within the previous 6 months);
- Genital tract inflammation within 2 weeks before enrollment, or abnormal vaginal discharge that has not been treated;
- Concomitant malignant tumor at any other site;
- Other reproductive disorders;
- Alcohol abuse (> 20 g/day) or smoking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Shuangshuang Zhao, MD, 13662059332, shuangshuangzhao23@163.com
About this study
Official title: A Prospective Randomized Controlled Trial of Canagliflozin Combined With Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Carcinoma
This study aims to evaluate whether the addition of canagliflozin to levonorgestrel-releasing intrauterine system (LNG-IUS) treatment, as compared with matching placebo or with the addition of metformin, increases the rate of pathological complete response (CR) at Week 24 in patients who wish to preserve fertility and who are overweight or have impaired glucose tolerance, type 2 diabetes mellitus, or polycystic ovary syndrome, with a diagnosis of atypical endometrial hyperplasia (AEH) or early-stage endometrioid endometrial carcinoma. The safety of this regimen and its effects on body weight, metabolic parameters, fertility, and long-term disease outcomes will also be assessed.
- Being tested
- LNG-IUS: levonorgestrel intrauterine system, Metformin, Canagliflozin
- Keywords
- atypical endometrial hyperplasia, endometrioid endometrial cancer, fertility- sparing, conservative therapy, SGLT2 inhibitor
- Medical subject headings
- Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNG-IUS: levonorgestrel intrauterine systemDrug
Participants receiving LNG-IUS
MetforminDrug
oral metformin at 1000-2000 mg/day.
CanagliflozinDrug
oral canagliflozin 100 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| LNG-IUS | Placebo comparator | Participants receiving LNG-IUS only. Receives: Drug: LNG-IUS: levonorgestrel intrauterine system |
| LNG-IUS+Metformin | Experimental | Participants received LNG-IUS combined with oral metformin at 1000-2000 mg/day. Receives: Drug: LNG-IUS: levonorgestrel intrauterine system; Drug: Metformin |
| LNG-IUS+canagliflozin | Experimental | Participants received LNG-IUS combined with oral canagliflozin 100 mg once daily. Receives: Drug: LNG-IUS: levonorgestrel intrauterine system; Drug: Canagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (CR) rate of endometrial lesions at 24 weeks
Measured: 24 weeks after treatment initiation
Secondary outcomes (8)
Complete remission (CR) rate of endometrial lesions at 12 weeks
Measured: 12 weeks after treatment initiation
Time to achieve complete remission (CR)
Measured: From treatment initiation up to 2 years
Cumulative CR rate
Measured: From treatment initiation up to 2 years
Recurrence-free rate among participants achieving CR
Measured: From achievement of CR up to 2 years
Recurrence-free interval among participants achieving CR
Measured: From achievement of CR up to 2 years
Pregnancy rate
Assessed among participants attempting pregnancy during the 2-year follow-up period.
Measured: From achievement of CR up to 2 years
live birth rate
Assessed among participants attempting pregnancy during the 2-year follow-up period.
Measured: From achievement of CR up to 2 years
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: From treatment initiation to completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrioid Endometrial CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Yingmei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Yingmei, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890064
- Sponsor's protocol ID
- IRB2026-YX-538-01
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No