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Not yet recruitingNCT07890064Updated Oct 22, 2026

Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer

A Phase 2 interventional study of LNG-IUS: levonorgestrel intrauterine system and Metformin in Endometrioid Endometrial Cancer and Atypical Endometrial Hyperplasia, sponsored by Wang Yingmei. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Wang Yingmei · Phase 2, Interventional, and Treatment

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Endometrioid Endometrial Cancer
  • Atypical Endometrial Hyperplasia

Keywords

  • atypical endometrial hyperplasia
  • endometrioid endometrial cancer
  • fertility- sparing
  • conservative therapy
  • SGLT2 inhibitor
03

In context

Endometrial Hyperplasia

105 studies on the registry are indexed under Endometrial Hyperplasia; 36 are open to participants now.

This study's planned enrollment of 102 is above the median of 76 across 66 interventional studies indexed under Endometrial Hyperplasia.

Browse Endometrial Hyperplasia studies →

Lead sponsor

This is the only study on the registry with Wang Yingmei as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Female, aged 18-45 years, with a definite desire for fertility preservation
  2. First-time diagnosis of atypical endometrial hyperplasia (AH) or grade 1 endometrioid endometrial carcinoma (G1 EEC), confirmed by pathologists at the study center
  3. 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
  4. Positive expression of both estrogen receptor (ER) and progesterone receptor (PR)
  5. Normal hepatic and renal function
  6. No contraindications to progestin or canagliflozin therapy
  7. No hormonal therapy or SGLT2 inhibitor treatment lasting more than 1 month within the previous 6 months
  8. Presence of any of the following: diagnosed polycystic ovary syndrome (PCOS), overweight (BMI ≥ 24), impaired glucose tolerance, or diabetes mellitus
  9. No other fertility disorders and no contraindications to pregnancy
  10. Not currently pregnant
  11. Good compliance, willing to comply with subsequent assessments, treatment, and follow-up, with understanding and signing of the informed consent form

Exclusion criteria

Exclusion Criteria:

  1. History of allergy to LNG-IUS, SGLT2 inhibitors, or metformin, or any contraindication to these treatments;
  2. Overly large uterine cavity (mean diameter > 7 cm) or a history of LNG-IUS (Mirena) expulsion;
  3. Type 2 diabetes mellitus requiring insulin therapy, or glycated hemoglobin (HbA1c) > 8.5% (insulin users are excluded owing to the increased risk of ketoacidosis);
  4. History of type 1 diabetes mellitus, diabetic ketoacidosis, peripheral vascular disease, or diabetic foot ulcers;
  5. Long-term use of corticosteroids or insulin/insulin sensitizers;
  6. Baseline blood pressure below 90/60 mmHg;
  7. 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);
  8. 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);
  9. Genital tract inflammation within 2 weeks before enrollment, or abnormal vaginal discharge that has not been treated;
  10. Concomitant malignant tumor at any other site;
  11. Other reproductive disorders;
  12. Alcohol abuse (> 20 g/day) or smoking.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
102 participants (estimated)

Study arms

  • Placebo comparator
    LNG-IUS

    Participants receiving LNG-IUS only.

    Drug: LNG-IUS: levonorgestrel intrauterine system

  • Experimental
    LNG-IUS+Metformin

    Participants received LNG-IUS combined with oral metformin at 1000-2000 mg/day.

    Drug: LNG-IUS: levonorgestrel intrauterine system · Drug: Metformin

  • Experimental
    LNG-IUS+canagliflozin

    Participants received LNG-IUS combined with oral canagliflozin 100 mg once daily.

    Drug: LNG-IUS: levonorgestrel intrauterine system · Drug: Canagliflozin

Interventions

  • DrugLNG-IUS: levonorgestrel intrauterine system

    Participants receiving LNG-IUS

  • oral metformin at 1000-2000 mg/day.

  • oral canagliflozin 100 mg once daily

06

What researchers measure

Primary outcomes

  1. Complete remission (CR) rate of endometrial lesions at 24 weeks

    Time frame: 24 weeks after treatment initiation

Secondary outcomes

  1. Complete remission (CR) rate of endometrial lesions at 12 weeks

    Time frame: 12 weeks after treatment initiation

  2. Time to achieve complete remission (CR)

    Time frame: From treatment initiation up to 2 years

  3. Cumulative CR rate

    Time frame: From treatment initiation up to 2 years

  4. Recurrence-free rate among participants achieving CR

    Time frame: From achievement of CR up to 2 years

  5. Recurrence-free interval among participants achieving CR

    Time frame: From achievement of CR up to 2 years

  6. Pregnancy rate

    Assessed among participants attempting pregnancy during the 2-year follow-up period.

    Time frame: From achievement of CR up to 2 years

  7. live birth rate

    Assessed among participants attempting pregnancy during the 2-year follow-up period.

    Time frame: From achievement of CR up to 2 years

  8. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: From treatment initiation to completion

07

Study locations

1 site
  • Tianjin Medical University General Hospital
    Tianjin, Tianjin Municipality 300052, China
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Jan 2029, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2026
First posted
Oct 22, 2026
StartEst.
Jan 1, 2027
Primary completionEst.
Jan 1, 2029
CompletionEst.
Dec 31, 2031
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07890064
Lead sponsor
Wang Yingmei
Responsible party
Wang Yingmei (Department of Gynecology and Obstetrics, Tianjin Medical University General Hospital, Tianjin Medical University General Hospital) — Sponsor-investigator
First posted
Oct 22, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Jan 1, 2029 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Oct 22, 2026

Study contacts

Yingmei Wang, MD, PhD
Contact
wangyingmei@tmu.edu.cn
60363766
Shuangshuang Zhao, MD
Contact
shuangshuangzhao23@163.com
13662059332

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Metformin · Canagliflozin

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