Clinical trial · Interventional
CANA/Met in Non-diabetic Women With PCOS
Canagliflozin Administration in Non-diabetic Women With Polycystic Ovarian Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Polycystic ovary syndrome (PCOS), which is associated with hyperinsulinaemia, hyperandrogenaemia, impaired glucose metabolism and aberrant adipokines production from the adipose tissue, is a heterogeneous reproductive and endocrine disorder.Currently, metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS. SGLT-2 inhibitor, a novel glucose-lowering medication, have been shown to have positive effects on reducing body weight, blood pressure and cardiovascular events in individuals with diabetes mellitus. However, evidences related to its management in non-diabetic PCOS women are limited. Hence, we want to give canangliflozin combined with metformin to women with PCOS to see its effect on insulin resistance.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Canagliflozin combined with metformin | Drug | — | UNRESOLVED |
| metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Canagliflozin/metformin group
- description
- Intervention with canagliflozin combined with metformin for three months
- interventionNames
- Drug: Canagliflozin combined with metformin
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator: Metformin group
- description
- Intervention with metformin for three months
- interventionNames
- Drug: metformin
Primary outcomes (1)
- measure
- Body mass index
- timeFrame
- Three months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female aged 18- 45 years old; 2. Diagnosed criteria meet the Rotterdam criteria (2003); 3. Insulin Resistance Exclusion Criteria: 1. Women who are pregnant or have a pregnancy plan within six months; 2. Confirmed diagnosis of diabetes. 3. Congenital adrenocortical hyperplasia; 4. Hyperprolactinemia; 5. Hyperthyroidism or hypothyroidism; 6. Combined with liver or kidney diseases; 7. Abnormal liver function (≥ 3 times of the upper limit of normal range); 8. Abnormal renal function (GFR\<60ml/min/1.73m2); 9. Adrenal or ovarian tumors secreting androgens; 10. Used metformin, glucagon-like peptide-1 receptor agonists, pioglitazone and contraceptives in the last 3 months.
References
Publications (1)
- DERIVEDZhang J, Xing C, Cheng X, He B. Canagliflozin combined with metformin versus metformin monotherapy for endocrine and metabolic profiles in overweight and obese women with polycystic ovary syndrome: A single-center, open-labeled prospective randomized controlled trial. Front Endocrinol (Lausanne). 2022 Sep 6;13:1003238. doi: 10.3389/fendo.2022.1003238. eCollection 2022. PMID 36147577