E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Polycystic ovary syndrome |
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E.1.1.1 | Medical condition in easily understood language |
Polycystic ovary syndrome (PCOS) is a common condition that affects how a woman’s ovaries work. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Does empagliflozin at a dose of 25mg improve enothelial function (cardiovascular risk marker) in women with PCOS? |
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E.2.2 | Secondary objectives of the trial |
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).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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) eGFR<60 6) Hypersensitivity to lactose 7) Severe hepatic impairment (ALT >3 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
To establish the effect of empagliflozin on endothelial function as measured by RHI (reactive hyperaemia index). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At baseline (visit 2) and after three months of treatment (visit 3). |
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E.5.2 | 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). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At baseline (visit 2) and after three months of treatment (visit 3). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Completion of all trial procedures by participants |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 28 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 28 |