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Completed

NCT Number: NCT04973891

CANA/Met in Non-diabetic Women With PCOS

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female aged 18- 45 years old;
  • Diagnosed criteria meet the Rotterdam criteria (2003);
  • Insulin Resistance

Exclusion criteria

  • Women who are pregnant or have a pregnancy plan within six months;
  • Confirmed diagnosis of diabetes.
  • Congenital adrenocortical hyperplasia;
  • Hyperprolactinemia;
  • Hyperthyroidism or hypothyroidism;
  • Combined with liver or kidney diseases;
  • 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 metformin, glucagon-like peptide-1 receptor agonists, pioglitazone and contraceptives in the last 3 months.

Treatment and study plan

Canagliflozin combined with metformin

Drug

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

Drug

Metformin, a classical and common insulin sensitizer that can reduce both hyperinsulinemia and hyperandrogenemia, is widely used for patients with PCOS.

Primary outcomes

  1. Body mass index

    Time frame: Three months

    Changes in body mass index (BMI)

Secondary outcomes

  1. Total testosterone

    Time frame: Three months

    Changes in total testosterone (TT)

  2. Androstenedione

    Time frame: Three months

    Changes in androstenedione (AND)

  3. Dehydroepiandrosterone sulfate

    Time frame: Three months

    Changes in dehydroepiandrosterone sulfate (DHEA-S)

  4. Sex hormone-binding globulin

    Time frame: Three months

    Changes in sex hormone-binding globulin (SHBG)

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

Canagliflozin Administration in Non-diabetic Women With Polycystic Ovarian Syndrome

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 22, 2021
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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