E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Síndrome de hiperestimulación ovárica en mujeres con hiperestimulación ovárica controlada en técnicas de reproducción asistida |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033266 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To identify the effective doses of quinagolide, including the lowest effective dose, compared to placebo in preventing moderate/severe early ovarian hyperstimulation syndrome (OHSS) |
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E.2.2 | Secondary objectives of the trial |
(please note: abbreviated du to limitation in characters - see protocol section 2.1) •To estimate the dose-response in preventing moderate/severe early OHSS •To estimate the effects in reduction of the incidence of ascites, peritoneal fluid accumulation and on the frequency of subjects requiring ascitic drainage •To estimate the effects on the proportion of subjects hospitalised or restricted to bed rest because of OHSS, on the duration of hospitalisation and bed rest •To estimate the effects on the frequency of individual signs/symptoms and presentation pattern of moderate/severe OHSS •To estimate the effects on body measurements •To estimate the effects in preventing moderate/severe late OHSS •To estimate the effects on clinical pregnancy rate •To establish the safety profile |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Subjects eligible for this study are women 21-37 years of age (both inclusive), generally healthy and with BMI 18-29 kg/m2 (both inclusive) who are undergoing controlled ovarian hyperstimulation for assisted reproductive technologies and who present with a risk of developing OHSS. They must have 20-30 follicles (both inclusive) ≥10 mm at the time of hCG administration, but serum estradiol below 6,000 pg/mL. Eligible subjects must have been infertile for at least 1 year and willing to accept transfer of 1 or 2 embryos.
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E.4 | Principal exclusion criteria |
Subjects with a history of psychotic disorder, hypotension, orthostatic hypotension or recurrent syncope, or with impaired liver or kidney function are not eligible. Also, subjects being treated for hypertension or receiving therapy with dopamine agonists, dopamine antagonists, anti-psychotics, anti-depressants, anxiolytics, hypnotics or sedatives are not eligible.
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E.5 End points |
E.5.1 | Primary end point(s) |
Presence of moderate/severe early OHSS (onset ≤ 9 days after hCG administration)
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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.8.5 | 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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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provided in protocol section 14.3 |
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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 | |
E.8.9.1 | In the Member State concerned days | |