Single Centered Diary-based Study to Identify Course and Characteristics of Hormone Withdrawal Headaches/Migraines in Users of Combined Hormonal Contraceptives
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedades del Sistema Nervioso Central+1
+ Enfermedades del Cerebro
+ Trastornos de la Migraña
Solo Casos
Examinando las características de las personas con una enfermedad para identificar factores genéticos o ambientales que contribuyen a la condición.Resumen
Fecha de inicio: 1 de enero de 2017
Fecha en la que se inscribió al primer participante.Participant recruitment is performed through advertisement placed in University Zürich (USZ) online. Advertisement in offices of neurologists and headache specialists, homepage of the Swiss headache society. Interested women contact the investigators via email and are called back by one of the study doctors or students within 1 day from Monday-Friday. This phone call is thought to inform the women about the study in more detail and for the investigators to check eligibility. During this call the participants are informed about the study procedure and can ask any question. Here most important points are use of a CHC in a 21/7 regimen, regular (at least once on two months) withdrawal migraine/headaches, intention to continue the use of the contraceptive for 3 more months. If the participants decide to participate, inclusion and exclusion criteria are checked. If women are applicable they receive the consent form and the study information with an envelope for return. If more questions come up the investigators are available per email and phone for answers. If a patient doesn't return the consent form the investigator will delete the personal data, which collected before. Only the year of birth will be noted in the personal data. After consent participants receive headaches diaries (with mail /post) and a prepaid envelope (for return). Participants are also offered the option to return their diaries electronically via email to the study doctor. Furthermore participants receive in a second phone contact instructions, how to fill in the headache diary and the day of study start (first day of the next pill package). Headache diaries should be returned monthly (per email or post) and are conducted for 3 pill cycles. If complete headache diaries are not returned participants will be contacted per email after 1 week to remind the participants. If this email is not being answered within another week a phone contact will take place to identify potential reasons for noncompliance or withdrawal of consent or drop out. Observation period 3 pill cycles : 3 times 28 days Outcomes of the Research Project: * Daily number of headaches and migraine in each day of the observation cycle.and during the Hormone-free interval (HFI) * First day of migraine in the pill-free interval * Start of migraine in relation to withdrawal bleeding * Start of and number of prolonged migraines >24 hours in the pill-free interval and the phase of hormone intake. * Pain intensity in the pill-free interval in comparison to the pill-phase * Number of rescue medications/ migraine day during HFI and during pill intake * efficacy of the medications (did medication stop the attack and did the attack return after maximal 8 hours) * Within patient variability of the first migraine day in the HFI. Statistical Methodology: * Primary and secondary endpoints will be calculated as frequencies and percentages. * For comparison the number of prolonged attacks during pill use and the HFI prolonged attacks per day of the observation interval are calculated and thereafter chi-square test for comparisons is used . * Software programme is used for data analyses.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 47 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Solo Casos
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 50 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación