E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Polycystic ovary syndrome (PCOS) |
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E.1.1.1 | Medical condition in easily understood language |
Polycystic ovary syndrome (PCOS) |
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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 |
To study if the pregnancy rates (COPR: cumulative ongoing pregnancy rate) after 3 treatment cycles with inositol are comparable to 3 cycles of ovulation induction with clomiphene citrate. |
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E.2.2 | Secondary objectives of the trial |
To investigate whether the compliance for the patient is acceptable. Therefore, potential adverse events (e.g. ovarian hyperstimulation syndrome), the occurrence of ovulation, cancelling of treatment cycles, and multiple pregnancies are registered. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Rotterdam criteria for PCOS (cf. the recent ESHRE guidelines): at least 2 out of 3 criteria should be fulfilled: - irregular cycle (shorter than 21 days or longer than 35 days); - clinical (modified Ferriman-Gallwey score ≥ 6) or biochemical signs (elevated free testosterone) of hyperandrogenism (www.eshre.eu/Guidelines-and-Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx); - PCO ovaries on ultrasound (www.eshre.eu/Guidelines-and-Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx): multiple small cysts (≥ 20 per ovary and/or an ovarion volume ≥ 10 ml, measured with a probe >8 MHz) in both ovaries.
Age: 18 until 40 years old (extremes included).
A first treatment cycle, possibly combined with intra uterine insemination (IUI) and this for (one of) the following reasons: - mild male factor (as defined by each local center) - endometriosis AFS score 1 or 2
Use of own or donor sperm.
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E.4 | Principal exclusion criteria |
- Tubal factors - Uterine factors - Endometriosis AFS score 3 or 4 - Moderate to severe male factor (as defined by each local center) - BMI > 35 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pregnancy rates (COPR: cumulative ongoing pregnancy rate) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 3 treatment cycles of inositol (study group) or 3 ovulation induction cycles with clomiphene citrate (control group) |
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E.5.2 | Secondary end point(s) |
Live birth rate number of gestational sacs number of cancelled treatment cycles and persistent anovulation |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
32-42 weeks after conception at the time of the first ultrasound (around 7 weeks) during the study |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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) | 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
| 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 | 4 |
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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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 | 10 |
E.8.9.1 | In the Member State concerned days | |
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 | 10 |