E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
polycystic ovary syndrome |
|
E.1.1.1 | Medical condition in easily understood language |
polycystic ovary syndrome |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036050 |
E.1.2 | Term | Polycystic ovary |
E.1.2 | System Organ Class | 100000004872 |
|
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 |
To assess the treatment effect of LIK066 on hyperandrogenism at Day 15 in overweight and obese subjects with PCOS |
|
E.2.2 | Secondary objectives of the trial |
- To assess the safety and tolerability of LIK066 in overweight and obese subjects with PCOS throughout the study.
- To evaluate the treatment effect of LIK066 on gonadotropins and sex steroid levels. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- PCOS (diagnosed as clinical or biochemical hyperandrogenism, amenorrhea or oligomenorrhea and exclusion of other causes of hyperandrogenism.
- Overweight/obese subjects with BMI equal to or > 27 kg/m^2, and stable weight +/- 3 kg over previous 3 months
- Subjects must use non-hormonal methods of contraception during the study.
- See further details on protocol. |
|
E.4 | Principal exclusion criteria |
- Subjects with exogenous causes of hirsutism.
- Menstruation in the 30 days prior to screening or treatment.
- Pregnant or nursing (lactating) women.
- Use of prohibited medications.
- Preexisting medical condition which may significantly alter the absorption, metabolism, or excretion of the study drug, or which may jeopardize the subject in case of participation in the study.
- See further details on protocol. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in average morning fasting free testosterone blood concentrations from baseline |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Change from baseline in luteinizing hormone (LH) at Day 15
- Change from baseline in follicle stimulating hormone (FSH) at Day 15
- Change from baseline in sex hormone binding globulin (SHBG) at Day
15
- Change from baseline in androstenedione at Day 15
- Change from baseline in dehydroepiandrostenedione (DHEA) at Day 15
- Change from baseline in dehydroepiandrostenedione sulfate (DHEAS)
at Day 15
- Change from baseline in total testosterone, at Day 15
- Change from baseline in free androgen index (FAI), at Day 15
-Adverse events throughout the study, serum electrolytes and
hematocrit on Day 15 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
E.8.2.2 | Placebo | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |