- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00781456
A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches
A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy of DR-105 Compared to Placebo For the Management of Menstrually-Related Migraine Headaches.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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La Mesa, California, Estados Unidos, 91942
- Teva Investigational Site
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San Diego, California, Estados Unidos, 92108
- Duramed Investigational Site
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San Diego, California, Estados Unidos, 92123
- Teva Investigational Site
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San Francisco, California, Estados Unidos, 94109-4841
- Duramed Investigational Site
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20036
- Duramed Investigational Site
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Florida
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West Palm Beach, Florida, Estados Unidos, 33409
- Duramed Investigational Site
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Georgia
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Savannah, Georgia, Estados Unidos, 31406
- Teva Investigational Site
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New Jersey
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Edison, New Jersey, Estados Unidos, 08817
- Duramed Investigational Site
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New York
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New York, New York, Estados Unidos, 10022
- Duramed Investigational Site
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Teva Investigational Site
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74105
- Teva Investigational Site
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Oregon
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Medford, Oregon, Estados Unidos, 97504
- Teva Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19114
- Duramed Investigational Site
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Uniontown, Pennsylvania, Estados Unidos, 15401
- Teva Investigational Site
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29201
- Teva Investigational Site
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Hilton Head, South Carolina, Estados Unidos, 29926
- Teva Investigational Site
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38120
- Teva Investigational Site
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Texas
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Dallas, Texas, Estados Unidos, 75234
- Duramed Investigational Site
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Houston, Texas, Estados Unidos, 77054
- Teva Investigational Site
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San Antonio, Texas, Estados Unidos, 78258
- Duramed Investigational Site
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Virginia
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Virginia Beach, Virginia, Estados Unidos, 23454
- Duramed Investigational Site
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Duramed Investigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Premenopausal, non-pregnant, non-lactating
- History of migraine headaches without aura for at least 6 months
- History of migraine headaches associated with menstruation
- Others as directed by FDA-approved protocol
Exclusion Criteria:
- History of migraine headaches with aura or focal neurological symptoms
- Any contraindication to the use of oral contraceptives
- Others as dictated by FDA-approved protocol
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 91-day Levonorgestrel Oral Contraceptive
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
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Tratamiento de 91 días que consta de 84 comprimidos combinados azules que contienen 150 µg de LNG/30 µg de EE y 7 comprimidos amarillos que contienen 10 µg de EE.
Otros nombres:
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Comparador de placebos: Placebo
Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
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1 tablet daily to match experimental arm
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period
Periodo de tiempo: Baseline (25-35 days before Day 1) and Days 1-91
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The number of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) through the end of the 91-day treatment period compared with Baseline (the 25- to 35-day baseline qualification period).
Participants recorded the incidence, timing and intensity of migraines in a migraine diary during the prequalification period and throughout the 91-day treatment period.
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Baseline (25-35 days before Day 1) and Days 1-91
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months
Periodo de tiempo: Baseline, Month1, Month 2 and Month 3
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The percentage of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) compared to Baseline at each month of the treatment period.
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Baseline, Month1, Month 2 and Month 3
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Change From Baseline in Average Migraine Severity
Periodo de tiempo: Baseline and Month 1, Month 2 and Month 3
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Migraine severity was recorded by participants in the Baseline qualification diary and study migraine diary during the treatment period. Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication. Average migraine severity is defined as the sum of the severity ratings divided by the total number of migraine episodes reported during the observation period (for example, Baseline, First Month, Second Month, Third Month, and 91-Day Treatment Period). A negative change from Baseline score indicates improvement in severity. |
Baseline and Month 1, Month 2 and Month 3
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Percentage of Participants Who Required Rescue Medications During the Study Period
Periodo de tiempo: Baseline, Month 1, Month 2 and Month 3
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Participants recorded use of rescue medications for migraines in the migraine diary during the course of study treatment.
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Baseline, Month 1, Month 2 and Month 3
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Change From Baseline in Migraine Disability Assessment
Periodo de tiempo: Baseline and Week 15
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The migraine disability assessment (MIDAS) test is used to determine how severely migraines affect a patient's life. Participants were asked five questions about how often their headaches limited their ability to go to work or school, to do household work or to do family or leisure activities in the past 3 months. The MIDAS score equals the sum of the days answered for each question and ranges from 0 (no disability) to approximately 270 (severe disability; the upper bound is dependent on the number of days a participant would plan to work or participate in other activities). The MIDAS score is classified into four grades of severity:
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Baseline and Week 15
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Change From Baseline in Headache Impact Test
Periodo de tiempo: Baseline and Week 15
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The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on patients' ability to function on the job, at school, at home and in social situations. HIT-6 consists of 6 questions each scored on a scale from Never (6 points) to Always (13 points). The total score ranges from 36 to 78 with higher scores indicating greater impact on life. There was an error in administration of the HIT-6 in this study. Question 6 was not administered, and question 3 from the MIDAS was included instead. Therefore, the total score of the HIT-6 could not be calculated. |
Baseline and Week 15
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Number of Participants With Adverse Events (AEs)
Periodo de tiempo: Up to 15 weeks
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An AE is any untoward medical occurrence in a clinical investigation participant and which does not necessarily have to have a causal relationship with this treatment or clinical study. The following definitions were used to assess AE severity: Mild: Awareness of signs or symptoms, but they are easily tolerated; Moderate: Enough discomfort to cause interference with usual activity; Severe: Incapacitating, with inability to perform usual activity. Relationship to study drug was assessed as either: None: Causal relationship can be ruled out; Possibly: Causal relationship at least reasonably possible, i.e. relationship cannot be ruled out; Definitely: Causal relationship is certain. A serious adverse event (SAE) is one that met any one of the following criteria:
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Up to 15 weeks
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Mean Number of Days of Bleeding or Spotting
Periodo de tiempo: 91-day treatment period
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Bleeding and spotting were recorded by participants in the migraine diary during the 91-day treatment period.
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91-day treatment period
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Dolor
- Manifestaciones neurológicas
- Trastornos de cefalea primaria
- Trastornos de dolor de cabeza
- Trastornos de migraña
- Dolor de cabeza
- Efectos fisiológicos de las drogas
- Agentes Anticonceptivos Hormonales
- Agentes de control reproductivo
- Agentes anticonceptivos femeninos
- Anticonceptivos, Orales, Sintéticos
- Levonorgestrel
- Agentes anticonceptivos
- Anticonceptivos Orales
Otros números de identificación del estudio
- DR-105-201
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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