Clinical trial NCT04213677: Dapagliflozin Efficacy and Action in PCOS
Official title: Efficacy and Safety of Dapagliflozin in Polycystic Ovary Syndrome: a Multicentre, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
SGLT2 inhibitor
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Improvement in insulin resistance over 12 weeks
timeFrame: Baseline and 12 weeks
measure: Improvement in serum androgen level over 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in AUC (area under a curve) of glucose and insulin during the oral glucose tolerant test (OGTT)
timeFrame: Baseline to 12 week
measure: Change in serum free testosterone(FT)
timeFrame: Baseline to 12 week
measure: Change in serum sex hormone binding globulin(SHBG)
timeFrame: Baseline to 12 week
measure: Net change in total testosterone (TT) level
timeFrame: Baseline and 12 weeks
measure: Net change in dehydroepiandrosterone-sulfate(DHEAS) level
timeFrame: Baseline and 12 weeks
measure: Net change in androstenedione(AD) level
timeFrame: Baseline and 12 weeks
measure: Net change in luteinzing hormone(LH) level
timeFrame: Baseline and 12 weeks
measure: Net change in waist circumference
timeFrame: Baseline to 12 week
measure: Net Change in liver fat
timeFrame: Baseline to 12 week
measure: Change in ovulation rate assessed by serum progesterone
timeFrame: Baseline to 12 week
measure: Net change in body weight
timeFrame: Baseline to 12 week
measure: Net change in BMI
timeFrame: Baseline to 12 week
measure: Net change in glucose
timeFrame: Baseline to 12 week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
References: