| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| This study will investigate the use of 4 doses of combined contraceptives (a progestin with an estrogen) in a vaginal ring dosage form for the treatment of dysmenorrhea (menstrual cramping pain). A placebo control arm will also be utilized. |
| Este estudio investigará el uso de 4 dosis de contraceptivos combinados (un progestógeno con un estrógeno) en una formulación de dosis de anillo vaginal, para el tratamiento de dismenorrea (dolor cólico menstrual). También se utilizará una rama control de Placebo. |
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| E.1.1.1 | Medical condition in easily understood language |
| Prevention of menstrual cramping pain |
| Prevención del dolor cólico menstrual |
|
| 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 at least one dose of progestin/estrogen amongst the 4 active doses being tested, administered as a vaginal ring, that shows clinically relevant treatment efficacy in relief of primary dysmenorrhea, as demonstrated by a statistically significantly larger reduction (as compared to baseline) in mean menstrual cramping pain score compared to placebo. |
| En el alivio de la dismenorrea primaria, demostrada por una reducción mayor de forma estadísticamente significativa (en comparación con el momento basal) de la puntuación media de dolor cólico menstrual en comparación con un placebo. |
|
| E.2.2 | Secondary objectives of the trial |
In subjects with primary dysmenorrhea:
-To evaluate the treatment efficacy based on the intake of ibuprofen rescue medication and impact on daily life, as compared to baseline
-To assess the measurement characteristics and psychometric properties of the newly developed Dysmenorrhea Daily Diary, including a determination of the minimally-important difference in pelvic pain, as compared to baseline
-To evaluate the vaginal bleeding pattern associated with treatment
-To evaluate the general safety and tolerability of treatment |
En participantes con dismenorrea primaria:
-Evaluar la eficacia del tratamiento basada en la toma de medicación de rescate con ibuprofeno y la repercusión sobre la vida diaria en comparación con el momento basal.
-Evaluar las características de medición y las propiedades psicométricas del diario desarrollado recientemente Diario para la dismenorrea (DysDD, Dysmenorrhea Daily Diary) (apéndice 4), incluida una determinación de la diferencia mínimamente importante (DMI) en el dolor pélvico, en comparación con el momento basal.
-Evaluar el patrón de hemorragia vaginal asociado al tratamiento.
-Evaluar la seguridad y tolerabilidad generales del tratamiento. |
|
| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
| ICF ( version 00 Farmacogenetic 11/Jul/ 2012) |
| HIP (Versión 00 Farmacogenético del 11/Jul/ 2012) |
|
| E.3 | Principal inclusion criteria |
1. Subject must be willing and able to provide written informed consent for the trial.
2. Subject must be female.
3. Subject must be> or = to 18 to< or = to 55 years of age.
4. Subject must have a body mass index (BMI) ?18 and ?35.
5. Subject must have an established diagnosis of primary dysmenorrhea, characterized by menstrual pain in the absence of detectable pelvic pathology (eg, endometriosis, fibroids, pelvic inflammatory disease).
6. Each non-sterilized sexually active subject of child-bearing potential must agree to use condoms for contraception during the entire screening period, treatment period, and post-treatment period until the final study visit.
7. Subject using a hormonal contraceptive (combined or progestin-only), or a non-hormonal IUD, at the screening visit must agree to stop using that method.
8. Subject has regular menstrual cycles ranging from 24 to 35 days in length (to be confirmed at the randomization visit following completion of a baseline menstrual cycle). |
1.La participante debe estar dispuesta a otorgar su consentimiento informado por escrito para el ensayo y debe ser capaz de hacerlo.
2.La participante debe ser una mujer.
3.La participante debe tener ? 18 a ? 50 años de edad.
4.La participante debe tener un índice de masa corporal (IMC) ? 18 y ? 35.
5.La participante debe tener un diagnóstico establecido de dismenorrea primaria, caracterizada por dolor menstrual en ausencia de una enfermedad pélvica detectable (por ejemplo, endometriosis, fibromas, enfermedad inflamatoria pélvica).
6.Cada participante sexualmente activa con capacidad de procrear deberá comprometerse a utilizar preservativos como método anticonceptivo durante todo el período de selección, el período de tratamiento y el período de postratamiento hasta la visita final del estudio, a menos que ella o su pareja hayan sido esterilizados quirúrgicamente.
7.Las participantes que utilicen un anticonceptivo hormonal (combinado o de progestágenos solos) o un DIU no hormonal en la visita de selección deberán comprometerse a dejar de utilizar ese método.
8.La participante tiene ciclos menstruales regulares que oscilan entre 24 y 35 días de duración con una variación intraindividual permitida de ± 3 días (que se confirmará en la visita de aleatorización tras la finalización de un ciclo menstrual basal). |
|
| E.4 | Principal exclusion criteria |
1. Subject has any contraindication to the use of contraceptive steroids.
2. Subject has secondary dysmenorrhea ? ie, menstrual pain in the presence of detectable pelvic pathology (eg, endometriosis, fibroids, pelvic inflammatory disease).
3. Subject has not had spontaneous menstruation following a delivery or abortion at the screening visit.
4. The subject is breastfeeding or has not had spontaneous menstruation following completion of breastfeeding at the screening visit.
5. Subject has a history of malignancy ?5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
6. Subject had a documented abnormal cervical smear result within 6 months prior to the screening visit.
7. Subject routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking. |
1.La participante presenta alguna contraindicación para el uso de esteroides anticonceptivos.
2.La participante presenta dismenorrea secundaria, es decir, dolor menstrual en presencia de una enfermedad pélvica detectable (por ejemplo, endometriosis, fibromas, enfermedad inflamatoria pélvica).
3.La participante no ha tenido una menstruación espontánea después de un parto o aborto en la visita de selección.
4.La participante está lactando o no ha tenido una menstruación espontánea después de la lactancia en la visita de selección.
5.La participante ha tenido un tumor maligno en los ? 5 años anteriores a la firma del consentimiento informado, excepto un carcinoma basocelular o espinocelular de la piel debidamente tratado o un cáncer de cuello uterino in situ.
6.La participante tuvo un resultado documentado de citología cervical anormal en el plazo de 6 meses previos a la visita de selección.
7.La participante consume habitualmente > 2 bebidas alcohólicas al día o > 14 bebidas alcohólicas por semana, o realiza un consumo concentrado de alcohol. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Change from baseline at the end of the study in menstrual cramping pain |
| El criterio principal de valoración de la eficacia es la variación de la puntuación de dolor cólico menstrual |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| At the end of the study, following 2 treatment cycles. |
| Al final del ensayo y en los siguientes 2 ciclos de tratamiento. |
|
| E.5.2 | Secondary end point(s) |
| Change in total mean impact score from baseline through Treatment Cycle 2 (the mean of the sum of daily responses to questions 5, 7, 8, and 9) in the Dysmenorrhea Daily Diary; Change from baseline in total number of ibuprofen tablets taken; and Change from baseline in number of days of ibuprofen intake will be analyzed in the same manner as the primary variable. |
Los criterios de valoración secundarios de la eficacia se calculan desde la visita basal hasta el segundo episodio hemorrágico previsto durante el tratamiento y consisten en:
-puntuación total media de repercusión desde la visita basal hasta el segundo episodio hemorrágico previsto durante el tratamiento (la puntuación total media de repercusión media se define como la media de la suma de las respuestas diarias a las preguntas 5, 7, 8 y 9 del DysDD)
-número total de comprimidos de ibuprofeno tomados
-número de días de toma de ibuprofeno |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| At the end of the study, following 2 treatment cycles. |
| Al final del ensayo y en los siguientes 2 ciclos de tratamiento. |
|
| 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 | 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 | Yes |
| 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.8.2.4 | Number of treatment arms in the trial | 5 |
| 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 | 2 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 8 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Austria |
| Belgium |
| Chile |
| Colombia |
| Denmark |
| Germany |
| Mexico |
| Netherlands |
| New Zealand |
| Norway |
| Poland |
| South Africa |
| Spain |
| Sweden |
|
| 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 | 11 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 11 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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