Dapagliflozin Efficacy and Action in PCOS

NCT04213677 | Completed Phase 3

• 1 other identifier: NFEC-2019-243
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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

Keywords

Polycystic Ovary Syndrome; SGLT2 inhibitor

Outcome Measures

Primary Outcomes (2)

• Improvement in insulin resistance over 12 weeks

  Change in insulin resistance assessed by insulin sensitivity index(HOMA-IR)

  Baseline and 12 weeks

• Improvement in serum androgen level over 12 weeks

  Change in androgen level assessed by free testosterone index(FAI)

  Baseline and 12 weeks

Secondary Outcomes (13)

• Change in AUC (area under a curve) of glucose and insulin during the oral glucose tolerant test (OGTT)

  Baseline to 12 week

• Change in serum free testosterone(FT)

  Baseline to 12 week

• Change in serum sex hormone binding globulin(SHBG)

  Baseline to 12 week

• Net change in total testosterone (TT) level

  Baseline and 12 weeks

• Net change in dehydroepiandrosterone-sulfate(DHEAS) level

  Baseline and 12 weeks

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

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

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Placebo (Participants will receive placebo po qd)

Drug: Placebo

Interventions

Dapagliflozin DRUG

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

Dapagliflozin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women aged 18 to 45 years;
• Subjects with PCOS diagnosed by according to the Rotterdam criteria;
• BMI ≥24 kg/m2 and/ or Homeostatic model assessment of insulin resistance (HOMA-IR) with a cutoff ≥2.5;
• No pregnancy plan within the next 6 months;

You may not qualify if:

• Congenital adrenal hyperplasia such as 21-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, androgen-producing tumors of the adrenal gland or ovary;
• Other endocrine diseases include poorly controlled thyroid diseases (hyperthyroidism or hypothyroidism), acromegaly, type 2 diabetes;
• Patients with a history of acute / chronic infection, severe cardio-cerebrovascular diseases and acute / chronic pancreatitis;
• Taking any antidiabetic medication that would affect insulin resistance or hyperandrogenemia (i.e. TZD, GLP-1RA, DPP-4i, metformin) in the past one month;
• 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;
• History of recurrent urinary tract infection;
• History of malignant tumor;
• 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.
• 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);
• Women who are pregnant or plan to become pregnant;
• 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;
• Participation in other clinical trial in the 4 weeks before randomization;
• Patients who are unwilling or unable to give informed consent.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 30, 2019
• Study Start: March 20, 2020
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

CN (1)