E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypothyroidism in pregnant patients |
Ipotiroidismo in pazienti in gravidanza |
|
E.1.1.1 | Medical condition in easily understood language |
Hypothyroidism in pregnant patients |
Ipotiroidismo in pazienti in gravidanza |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10014698 |
E.1.2 | Term | Endocrine disorders |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
|
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 |
Comparison of effectiveness and satisfaction between two different formulation of L-thyroxine for the treatment of primary hypothyroidism in pregnant women diagnosed before than 10 weeks of gestation. |
Confronto dell’efficacia e del gradimento di due formulazioni di L-tiroxina per il trattamento dell’ipotiroidismo primario in donne in gravidanza entro la decima settimana di gestazione. |
|
E.2.2 | Secondary objectives of the trial |
- Evaluation of percentage of hypothyroidism persistence after delivery. - Evaluation of mean dose/Kg in pregnant women according to therapeutic target recommended by recent guidelines. |
-Valutazione della percentuale di persistenza dell’ipotiroidismo dopo il parto. -Valutazione del dosaggio medio/Kg in donne gravide in accordo con target terapeutico raccomandato dalle recenti linee guida. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
adult women, asian, hispanic, black patients, aged 18 - 50 yrs with TSH>2.5 mU/L before than 10 weeks of gestation. Patients treated after giving informed consent for therapy. |
donne adulte, razza caucasica, asiatica, ispanica, di età compresa tra i 18 e i 50 anni, con riscontro di TSH>2.5 mU/L entro la decima settimana di gravidanza. Ottenimento del consenso informato da parte delle pazienti. |
|
E.4 | Principal exclusion criteria |
previous treatment with L-thyroxine, treatment with drugs interfering with thyroid function (amiodarone, litium, interferon ..). Diagnosis of celiac disease, atrophic gastritis, other diseases with malabsorption. |
precedente terapia con tiroxina, trattamento con farmaci influenzanti la funzionalità tiroidea (amiodarone, litio, carbamazepina, interferone..). Diagnosi di celiachia, gastrite atrofica o altre forme di malassorbimento. |
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E.5 End points |
E.5.1 | Primary end point(s) |
identification of the best therapeutic formulation for the treatment of pregnant hypothyroid women. |
identificazione della migliore formulazione terapeutica per il trattamento della donna ipotiroidea in gravidanza. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Evaluation of mean dose/Kg in pregnant women according to therapeutic target recommended by recent guidelines. |
Valutazione del dosaggio medio/Kg in donne gravide in accordo con target terapeutico raccomandato dalle recenti linee guida |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
compliance of pregnant patients |
compliance delle pazienti gravide |
|
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
stesso farmaco con diversa formulazione |
same drug with different formulation |
|
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
|
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 | 24 |
E.8.9.1 | In the Member State concerned days | 0 |