Polycystic ovary syndrome
Conditions
Interventions
Trade Name: Jardiance
Product Name: Jardiance
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Empagliflozin
CAS Number: 864070-44-0
Concentration unit: mg milligram(s)
Trade Name: Glucop
Sponsors
Research & Development Department, Hull & East Yorkshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Women, aged 18-45 years (inclusive), with confirmed diagnosis of PCOS based on Rotterdam criteria. 2) Presence of both irregular periods and biochemical hyperandrogenaemia 3) Body mass index =25 4) Negative pregnancy test during screening visit and agree to use barrier contraception during the study period. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1) Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing’s disease and androgen-secreting tumours will be excluded by appropriate tests. 2) Any concurrent illness including type 2 diabetes. 3) Subjects who are on any of the following medications within 3 months of recruitment: • Metformin or other insulin-sensitizing medications (e.g., pioglitazone ) • Hormonal contraceptives (e.g., birth control pills, hormone-releasing implants, etc.) • Anti-androgens (e.g., spironolactone, flutamide, finasteride, etc.) • Clomiphene citrate or estrogen modulators such as letrozole • GnRH modulators such as leuprolide • Minoxidil 4) Women planning to conceive. 5) eGFR3 times ULN) 8) Women with history of recurrent urinary tract infections. 9) Haematocrit above the upper limit of normal range. 10) Have been involved in another medicinal trial (CTIMP) within the past four weeks. 11) Known hypersensitivity to the Investigational Medicinal Products or any of their excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does empagliflozin at a dose of 25mg improve enothelial function (cardiovascular risk marker) in women with PCOS?;Secondary Objective: 1) The effect of empagliflozin on inflammatory markers (hsCRP) 2) The effect of empagliflozin on insulin resistance as measured by HOMA (fasting glucose & insulin). 3) The effect of empagliflozin on body weight 4) The effect of empagliflozin on blood pressure (systolic and diastolic) 5) Effect of empagliflozin on lipid profile. 6) The effect of empagliflozin on hormonal parameters including free androgen index. 7) Effect of empagliflozin on endothelial dysfunction (microparticles). 8) The effect of empagliflozin on Quality of Life (QoL). ;Primary end point(s): To establish the effect of empagliflozin on endothelial function as measured by RHI (reactive hyperaemia index).;Timepoint(s) of evaluation of this end point: At baseline (visit 2) and after three months of treatment (visit 3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) The effect of empagliflozin on inflammatory markers (hsCRP) 2) The effect of empagliflozin on insulin resistance as measured by HOMA (fasting glucose & insulin). 3) The effect of empagliflozin on body weight 4) The effect of empagliflozin on blood pressure (systolic and diastolic) 5) Effect of empagliflozin on lipid profile. 6) The effect of empagliflozin on hormonal parameters including free androgen index. 7) Effect of empagliflozin on endothelial dysfunction (microparticles). 8) The effect of empagliflozin on Quality of Life (QoL).;Timepoint(s) of evaluation of this end point: At baseline (visit 2) and after three months of treatment (visit 3). | — |
Countries
United Kingdom
Contacts
Public ContactSathyapalan
Hull York Medical School
Outcome results
None listed