Dapagliflozin Efficacy and Action in PCOS

NCT ID: NCT04213677

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2022-11-01

Brief Summary

The purpose of this study is to assess the efficacy and safety of dapagliflozin on improving insulin resistance and hyperandrogenemia in obesity women with polycystic ovary syndrome.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dapagliflozin

Dapagliflozin (Participants will receive dapagliflozin 10mg po qd).

Group Type: EXPERIMENTAL

Dapagliflozin

Intervention Type: DRUG

Participants will receive dapagliflozin 10mg po qd. Additionally, participants will receive lifestyle modification and nutrition education.

Placebo

Placebo (Participants will receive placebo po qd)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive placebo po qd. Additionally, participants will receive lifestyle modification and nutrition education.

Interventions

Dapagliflozin

Participants will receive dapagliflozin 10mg po qd. Additionally, participants will receive lifestyle modification and nutrition education.

Intervention Type: DRUG

Placebo

Participants will receive placebo po qd. Additionally, participants will receive lifestyle modification and nutrition education.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. women aged 18 to 45 years;

2. Subjects with PCOS diagnosed by according to the Rotterdam criteria;

3. BMI ≥24 kg/m2 and/ or Homeostatic model assessment of insulin resistance (HOMA-IR) with a cutoff ≥2.5;

4. No pregnancy plan within the next 6 months;

Exclusion Criteria

1. Congenital adrenal hyperplasia such as 21-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, androgen-producing tumors of the adrenal gland or ovary;

2. Other endocrine diseases include poorly controlled thyroid diseases (hyperthyroidism or hypothyroidism), acromegaly, type 2 diabetes;

3. Patients with a history of acute / chronic infection, severe cardio-cerebrovascular diseases and acute / chronic pancreatitis;

4. Taking any antidiabetic medication that would affect insulin resistance or hyperandrogenemia (i.e. TZD, GLP-1RA, DPP-4i, metformin) in the past one month;

5. Taking letrozole, clomiphene, oral contraceptive, glucocorticoid, gonadotropin, gonadotropin releasing hormone agonist, anti-androgen drug (spironolactone, cycloproterenone acetate, Flutamide etc.) and/or other drugs for PCOS in the past three months;

6. History of recurrent urinary tract infection;

7. History of malignant tumor;

8. Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) or have a history of gastrointestinal surgery.

9. Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2);

10. Women who are pregnant or plan to become pregnant;

11. Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the interpretation of efficacy or safety data;

12. Participation in other clinical trial in the 4 weeks before randomization;

13. Patients who are unwilling or unable to give informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Huijie Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

NFEC-2019-243

Identifier Type: -

Identifier Source: org_study_id