Status:
COMPLETED
SGLT2 Inhibitors in Patients With PCOS
Lead Sponsor:
Shanghai 10th People's Hospital
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or...
Detailed Description
This clinical study aims to determine the safety and efficacy of canagliflozin vs metformin in Polycystic Ovary Syndrome (PCOS) patients with insulin resistance (IR). Methods: A single center, prospec...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Fmale aged 18- 45;
- Meet Rotterdam criteria;
- Insulin Rsistance
- Exclusion Criteria:
- Women who are pregnant or have a pregnancy plan within six months; ·Congenital adrenocortical hyperplasia;
- Hyperprolactinemia;
- Hyperthyroidism or hypothyroidism;
- Abnormal liver function (≥ 3 times of the upper limit of normal range);
- Abnormal renal function (GFR\<60ml/min/1.73m2);
- Adrenal or ovarian tumors secreting androgens;
- Used contraceptives, metformin, GLP-1RA, SGLT2I, pioglitazone and contraceptives in the last 3 month.
Exclusion
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04700839
Start Date
May 1 2020
End Date
April 30 2021
Last Update
September 10 2022
Active Locations (1)
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1
Shanghai Tenth People' Hospital
Shanghai, Shanghai Municipality, China, 200072