CANA/Met in Non-diabetic Women With PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

Canagliflozin Administration in Non-diabetic Women With Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04973891
• Other study ID #: 777
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 7, 2021
• Est. completion date: March 8, 2022

Study information

• Verified date: April 2022
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 8, 2022
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Canagliflozin combined with metformin
Canagliflozin, a novel glucose-lowering medication, has been shown to have positive effects on reducing body weight, blood pressure and cardiovascular events. Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS.
• metformin
Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS.

Locations

Country	Name	City	State
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index	Changes in body mass index (BMI)	Three months
Secondary	Total testosterone	Changes in total testosterone (TT)	Three months
Secondary	Androstenedione	Changes in androstenedione (AND)	Three months
Secondary	Dehydroepiandrosterone sulfate	Changes in dehydroepiandrosterone sulfate (DHEA-S)	Three months
Secondary	Sex hormone-binding globulin	Changes in sex hormone-binding globulin (SHBG)	Three months