- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00128726
The Effects of Continuous Administration of a Monophasic Oral Contraceptive on Bleeding Days and Endometrial and Ovarian Function
20 de diciembre de 2012 actualizado por: Richard S. Legro, M.D., Milton S. Hershey Medical Center
The purpose of this study is to determine the safety and efficacy of a continuous combined oral contraceptive pill (CCOCP) regimen.
The investigators hypothesize that there will be a decrease in the number of vaginal bleeding days in the continuous regimen compared to a traditional 21/7 regimen.
In addition, the investigators hypothesize that there will be increased endometrial and ovarian suppression in the CCOCP regimen.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
In the U.S. many women of reproductive age use some form of contraception, 23% of whom use estrogen-progesterone combined oral contraceptives.
Low-dose oral contraceptives suppress ovulation and dominant follicle selection by inhibiting luteinizing hormone and follicle stimulating hormone secretion by the pituitary gland.
Under social, cultural and religious influences, women have traditionally been prescribed oral contraceptives in a pattern of 21 days of active pills with seven days of inactive pills as a way of mimicking the natural menstrual cycle and provide reassurance of the absence of pregnancy by a withdrawal bleed during the placebo period.
However, the withdrawal bleeding that occurs during the placebo period may still present with debilitating menstrual symptoms such as cramping, spotting break through bleeding, menstrual migraines and anemia.
These menstrual disorders remain one of the most common reasons for prescribing the oral contraceptives.
Suppression of bleeding by discarding the seven placebo tablets has been advocated for women with severe mental disabilities that impair hygiene and proper use, as well as for occasional use by women inconvenienced by menstruation (i.e.
female athletes during competition and women in the military).
Additionally, many physicians have used oral contraceptive pill regimens to treat endometriosis, premenstrual syndrome, anovulatory dysfunctional uterine bleeding, acne, hirsutism and anemia.
The seven day pills free ovarian axis and ovarian follicular development and increase ovarian sex steroid production which may result in mild exacerbations of the treated condition.
There is a growing patient preference to avoid vaginal bleeding completely, both in pre-menopausal and post-menopausal hormone replacement regimens in the general population.
This is reflected in a woman's attitude about changing menstrual bleeding patterns as assessed by a 1996 Dutch survey.
The majority of women in all studied age groups said that they would prefer decreasing the frequency of bleeding to less than once a month or completely eliminating menses altogether through the use of oral contraceptives.
Therefore, reducing bleeding days is an important goal for improving quality of life in women suffering from the discomfort and inconvenience of withdrawal bleeding.
Tipo de estudio
De observación
Inscripción (Actual)
62
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033-0850
- The Penn State Hershey Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 35 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra de probabilidad
Población de estudio
Healthy women between 18-35 years of age who wish to use a continuous combined oral contraceptive and are non-smokers.
Must have regular menstrual cycles for a 3 month period.
Descripción
Inclusion Criteria:
- Healthy women of legal age of consent between 18-35 years who wish to use a continuous combined oral contraceptive and are non-smokers.
- Must have a regular (25-31) day menstrual cycle for the three month period preceding enrollment.
- Subject will comply with protocol, in the opinion of the investigator.
Exclusion Criteria:
- Thrombophlebitis
- Known or suspected clotting disorders
- Cerebrovascular or coronary artery disease or myocardial infarction
- Malignancy
- Known or suspected estrogen dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products
- Hyperlipidemia - fasting cholesterol level greater than 6.73 mmol/L (260mg); fasting triglyceride level greater than 3.39 mmol/L (300mg/dl); high cholesterol.
- Diabetes mellitus
- Migraine or increased sensitivity of headaches during previous estrogen or oral contraceptive study
- Depression requiring hospitalization or associated with suicidal ideation
- Chronic renal disease
- Known hypersensitivity to estrogens and/or progestogens
- Neuro-ocular disorders
- Cholestatic jaundice
- Pregnancy while taking oral contraceptives
- Persistent non compliance with taking medication
- Serious adverse experiences with oral contraceptive use
- Malabsorption due to illness or surgery
- Use of any experimental drug or device within the last 90 days before study drug administration
- Any anticonvulsant medications
- Any use of rifampin within 3 months of enrollment
- Any use of lipid lowering agents
- Impaired liver function or disease
- Known or suspected pregnancy
- Hypertension whether treated or untreated
- Cervical cytological smear or low grade squamous intraepithelial lesion (SIL) or greater that is untreated within the last year
- The use of an intrauterine device (IUD) or injectable or implantable estrogen, progestogens, or androgens during the six month period before enrollment; or oral contraceptive or sex hormone use within three cycles before enrollment.
- Breast feeding
- Known or suspected alcoholism or drug abuse
- Smoking
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Richard S Legro, M.D., The Penn State Hershey Medical Center/College of Medicine
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2001
Finalización del estudio (Actual)
1 de agosto de 2006
Fechas de registro del estudio
Enviado por primera vez
8 de agosto de 2005
Primero enviado que cumplió con los criterios de control de calidad
9 de agosto de 2005
Publicado por primera vez (Estimar)
10 de agosto de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
21 de diciembre de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
20 de diciembre de 2012
Última verificación
1 de diciembre de 2012
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HY01-190
- R01HD043332 (Subvención/contrato del NIH de EE. UU.)
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. .