E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
"Deshabituación tabáquica en mujeres" "Smoking cessation in women" |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053325 |
E.1.2 | Term | Smoking cessation therapy |
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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 |
Saber si el éxito de la dehabituación tabáquica utilizando terapia de sustitución de burpropion en mujeres fumadoras, podría estar influenciada por la fase hormonal, estrogénica o luteínica" Saber si el éxito de la dehabituación tabáquica utilizando terapia de sustitución de nicotina en mujeres fumadoras, podría estar influenciada por la fase hormonal, estrogénica o luteínica" The main objetive is to know if the efectivity of smoking cessation, in smoking women, using bupropion is influenced of hormone´s fase, estrogenic or lutenic The main objetive is to know if the efectivity of smoking cessation, in smoking women, using nicotine is influenced of hormone´s fase, estrogenic or lutenic |
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E.2.2 | Secondary objectives of the trial |
"Establecer en que momento del ciclo es mejor para la mujer comenzar la deshabitualización tabáquica con terpia sustitutiva con bupropion Establecer en que momento del ciclo es mejor para la mujer comenzar la deshabitualización tabáquica con terpia sustitutiva Nicotina" "The secondary objetive is to know which is the best moment in the hormone´s fase to beging the smoking cessation with Bupropion The secondary objetive is to know which is the best moment in the hormone´s fase to beging the smoking cessation with Nicotine |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Ser mujer fumadore, independientemente de la cantidad de cig/día consumidos y de la motivación para dejar el hábito -Edad igual o superior a 18 años -Personas que otorguen su consentimiento a participar en este estudio tras haber sido informado de la metodología del mismo verbalmente y por escrito -Esté indicado el tratamiento con nicotina o bupropion
-To be a smoking woman, independent of the cigarretes/day of consum or motivation of stop smoking -Age 18 or more - People who give the permise to participe in the study and that have being informed orally and in paper -It´s indicates using nicotine or bupropion |
|
E.4 | Principal exclusion criteria |
-Menopausia, perimenopausia,embarazo -Estimación de baja propabilidad de poder realizar seguimiento al menos a 12 meses -Pacientes cuya situación patológica pueda interferir en el desarrollo del estudio
-Menopause, perimenopuse or pregnancy - Dificulties in following during unless 12 moths - Patients who´s psicologic situation could interfier in de desarrollation of the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Exfumador ( 1 año sin fumar) confirmado en la coximetría
Ex-smoking woman ( one year without smoking), confirmed by coximetry |
|
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 | 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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | 185 |
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 | 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
|
Dia fin de estudio: cuando se hace la última visita seguimiento, correspondiente a los 12 meses después de la fecha en la que ha dejado de fumar la última paciente: previsto en septiembre de 2008
Last day of the study: when the last visit is made, that it will be 12 months later than the last paciente has stop smoking, probably in September of 2008 |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |