E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Contraception |
Anticoncepción |
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E.1.1.1 | Medical condition in easily understood language |
Contraception |
Anticoncepción |
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E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
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 identify the menstrual bleeding profile among cooper and 13,5 LNG-IUD users. Hypothesis: 13,5 LNG-IUD users have less quantity and fewer days of menstrual bleeding that cooper IUD users. Among 13,5 LNG-IUD users the total blood loss per cycle progressively decreases with continued use. The number of spotting and menstrual bleeding days may initially increase but then decrease in the months that follow. |
El objetivo principal del estudio es evaluar las diferencias en el patrón de sangrado entre las usuarias del DIU-LNG 13,5mg y las del DIU-Cu de 380mm2. |
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E.2.2 | Secondary objectives of the trial |
To evaluate: - Spotting pattern. - Satisfaction and quality of life. - Continuation rates after 1st, 2nd and 3rd year. - Pain profile and adverse events. |
Los objetivos secundarios son: Evaluar: - patrón de sangrado - satisfacción y calidad de vida - la presencia e intensidad de dismenorrea - tasas de continuación después del primers, segundo y tercer año - dolor y efectos secundarios relacionados con el uso de cada DIU; |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Healthy female subject. - Parous or nulliparous women aged between 18 and 45 years who ask for an IUD as a contraceptive method. - History of regular cyclic menstrual periods ranged from 21 to 35 days with non-excessive menstrual blood loss. |
- Ser mujer en periodo fértil y edad comprendida entre 18 y 45 años. - Tener un ciclo menstrual normal. La menstruación se considerará normal cuando el sangrado uterino ocurra cada 28 +/- 7 días y la mujer refiera que no es excesivo. - Desear libremente un DIU como método contraceptivo. - Historial médico y examen físico que demuestre que no presente contraindicaciones para el uso de ninguno de los dos DIUs del estudio, teniendo en consideración los Criterios Médicos de Elegibilidad de la OMS del 2015. |
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E.4 | Principal exclusion criteria |
- Absolute contraindications to IUD use, according to the World Health Organization Medical Eligibility Criteria. - Contraindications to use 13,5 LNG-IUD. - Anemia. - Use of short or long-acting preparations containing sex hormones within the 12 weeks before the IUD insertion. - Known bleeding irregularities. - Pregnancy or breast-feeding. |
- No ser capaz de entender la naturaleza del ensayo y los procedimientos que deberá seguir. - No firmar el consentimiento informado. - Haber utilizado un método contraceptivo hormonal durante los 3 meses previos al inicio del estudio. - Antecedente o evidencia clínica de trastornos psiquiátricos, alcoholismo, abuso de fármacos u otras drogas o consumo habitual de fármacos psicoactivos. - Presentar intolerancia o reacciones adversas graves al levonorgestrel o al cobre o a alguno de los componentes del dispositivo. - Historial médico y examen físico que demuestre que presente alguna contraindicación para el uso de cualquiera de los dos DIUs estudiados, teniendo en consideración los Criterios Médicos de Eligibilidad de la OMS del 2015 (categorías 3 y 4). - Tener sangrado menstrual abundante (SMA), considerado como una pérdida de sangre menstrual excesiva que interfiere con la actividad física, emocional o social normal de la mujer, afectando a su calidad de vida. - Haber presentado sangrado intermenstrual o coitorragia en los últimos 3 ciclos menstruales. - Referir dismenorrea severa previa a la colocación del DIU. Se establecen 4 grados de intensidad de dismenorrea: sin dolor, leve, moderado, severo. - Constancia de anomalías en la cavidad uterina o canal cervical que dificulten o imposibiliten la colocación de un DIU - Analítica que demuestre anemia en el momento del inicio del estudio (Hb < 12 g/L). - Mujeres en tratamiento con fármacos anticoagulantes o antiagregantes. - Mujeres en tratamiento crónico con AINEs o antifibrinolíticos (como los ácidos aminocaproico y tranexámico). - Estar embarazadas o en periodo de lactancia. - Pacientes que, a juicio del investigador, sean consideradas candidatas inadecuadas para participar en el estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Number of menstrual bleeding days. Time frame: daily recorded during 90 days treatment period. - Menstrual bleeding characterization (intensity, pattern). Time frame: for 90 days treatment period. Classified using a 5-item Likert-like scale from ?none? to ?heavy? and a pictorial blood loss assessment chart (PBAC). - Serum hemoglobin, hematocrit and ferritin levels. |
- Número de días de sangrado menstrual - Características del sangrado menstrual - Niveles de hemoglobina, hematocrito y ferritina |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Daily recorded during 90 days treatment period. |
Registro diario durante un periodo de 90 días |
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E.5.2 | Secondary end point(s) |
- Number of spotting days. Time frame: daily recorded during 90 days treatment period. - Spotting bleeding characterization (intensity, pattern). Time frame: for 90 days treatment period. Classified using a 5-step scale from ?none? to ?heavy? and a pictorial blood loss assessment chart (PBAC). - Global satisfaction with 13,5 LNG-IUD using a 5-item Likert-like scale(from extremely unsatisfied to extremely satisfied). Time frame: at the single visit. - Quality of life after 1st, 2nd and 3rd year. Time framer: at the single visit - Continuation rate after 1st, 2nd and 3rd year. Time frame: at the single visit. - Adverse events as a measure of safety and tolerability. |
- Dolor percibido por la usuaria durante la inserción del dispositivo. - Facilidad de la inserción del dispositivo. - Días de sangrados irregulares. - Cantidad de sangrado irregular. - Días de dismenorrea. - Intensidad de dismenorrea. - Seguridad. - Satisfacción de la usuaria. - Calidad de vida. - Tasas de continuación al primer, segundo y tercer año. - Intención de continuar con el método a los 3 años. - Motivo de cambio/continuación del método. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Daily recorded during 90 days treatment period. |
Registro diario durante un periodo de 90 días |
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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 | 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 | 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 | Yes |
E.8.1.4 | Double blind | No |
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 |
Producto sanitario |
Medical device |
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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.8.5 | 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 | 3 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |