Canagliflozin added to a hormone coil for early endometrial cancer or precancer
Tests canagliflozin plus a hormone coil in women wanting to keep fertility.
Plain-language title generated from the registry record
Registry title: Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT07890064, who can take part
Where in China
- Tianjin Medical University General HospitalTianjin, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Wang Yingmei
- Trial code
- NCT07890064
- Record updated
- 22 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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; 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.
Exclusion: Long-term use of corticosteroids or insulin/insulin sensitizers; 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; 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; History of type 1 diabetes mellitus, diabetic ketoacidosis, peripheral vascular disease, or diabetic foot ulcers; Other reproductive disorders; Type 2 diabetes mellitus requiring insulin therapy, or glycated hemoglobin (HbA1c) > 8.5% (insulin users are excluded owing to the increased risk of ketoacidosis); 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); Baseline blood pressure below 90/60 mmHg; Alcohol abuse (> 20 g/day) or smoking.