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DREAMLANDCannabidiol in the Treatment of Women With Chronic Pelvic Pain Secondary to Endometriosis

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Cannabis Derivatives

+ Hormonal Contraceptive Agents

+ Placebo

Medicamento
Quiénes están siendo reclutados

Enfermedades Urogenitales+8

+ Enfermedades Genitales

+ Trastornos Mentales

A partir de 18 años
+14 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Controlado con PlaceboFase 2 & 3
Intervencional
Inicio del estudio: enero de 2023
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of Sao Paulo
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 3 de enero de 2023

Fecha en la que se inscribió al primer participante.

The Dreamland study is a two-arm, parallel-group, individually randomized (1:1 allocation ratio), controlled by disease stage, participant and investigator blinded, single-site superiority trial of oral cannabis extract (CBD). CBD will be given orally starting at 10 mg daily and up-titrated to a maximum dose of 150 mg daily. Dose up-titration will be based on clinical response or side effects, whichever comes first. After 63 days of treatment, gradual withdrawal will be performed during one week. Then, at 70 days, there will be an open-label extension wherein all participants from control group will be offered a course of CBD according to the same previous protocol. This research intends to : 1. Assess whether the daily use of CBD, for nine weeks, will reduce the pain level of these women. 2. Assess whether the daily use of CBD, for nine weeks, will modify pain threshold. 3. Assess whether the daily use of CBD, for nine weeks, will interfere in psychological symptoms. 4. Assess the possible adverse effects of using CBD

Título OficialCannabidiol in the Treatment of Women With Chronic Pelvic Pain Secondary to Endometriosis
NCT05670353
Patrocinador PrincipalUniversity of Sao Paulo
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 50 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Mujer

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades UrogenitalesEnfermedades GenitalesTrastornos MentalesAbuso de MarihuanaEnfermedades Genitales FemeninasEndometriosisEnfermedades Urogenitales Femeninas y Complicaciones del EmbarazoManifestaciones NeurológicasDolorSignos y SíntomasCondiciones Patológicas, Signos y Síntomas

Criterios

6 criterios de inclusión requeridos para participar
Women with chronic pelvic pain secondary to endometriosis surgically treated, with refractory symptoms, and who are taking complementary hormone therapy;
Women over 18 years of age who wish to participate in the clinical trial;
Willingness to voluntarily participate in the study to accept randomization to either of the two treatment arms;
Participating exclusively in this clinical trial during the study period;
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8 criterios de exclusión impiden participar
Chronic, severe or uncompensated medical conditions, such as: insulin-dependent diabetes (types 1 or 2); uncontrolled high blood pressure, lung disease such as asthma or other chronic obstructive pulmonary disease; hematological diseases, liver diseases, chronic kidney disease in advanced stage (grade 3, 4 and 5), metabolic disturbances and immunosuppression;
Use of any medication with potential interaction with CBD/THC (such as chloroquine, clobazan, warfarin, or valproic acid) or history of undesirable reactions prior to the use of this medications;
Inability to use oral medication;
Pregnancy or lactation;
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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

50% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Cannabis Derivatives (98% CBD, 2% THC) will be given orally starting at 10 mg daily and up-titrated to a maximum dose of 150 mg daily. Dose up-titration will be based on clinical response or side effects, whichever comes first. After 63 days of treatment, gradual withdrawal will be performed during one week. All patients will take hormonal contraceptives, preferably progestagen-only. All participants will perform invasive and non-invasive procedures with the nursing team. The invasive will be blood collections, to evaluate laboratory parameters. The non-invasive ones refer to the measurement of height, weight, body temperature, and sleep pattern, as will pain threshold. In addition, they will be monitored through weekly self-assessment scales, applied remotely, electronically (cell phones or computers), with an estimated duration of ten minutes each, which will have their responses recorded in an electronic database, by the study coordination team.

Grupo II

Placebo
Placebo will be given at the same protocol described before. The bottle, label, color and density of the contents will be the same. All patients will take hormonal contraceptives, preferably progestagen-only. Then, at 70 days, there will be an open-label extension wherein all participants from control group will be offered a course of active treatment according to the same previous protocol. All participants will perform invasive and non-invasive procedures with the nursing team. The invasive will be blood collections, to evaluate laboratory parameters. The non-invasive ones refer to the measurement of height, weight, body temperature, and sleep pattern, as will pain threshold. In addition, they will be monitored through weekly self-assessment scales, applied remotely, electronically (cell phones or computers), with an estimated duration of ten minutes each, which will have their responses recorded in an electronic database, by the study coordination team.

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

Suspendido

Center of Chronic Pelvic Pain and Gynecologic Endoscopy of Ribeirao Preto Medical School, University of Sao Paulo

Ribeirão Preto, BrazilAbrir Center of Chronic Pelvic Pain and Gynecologic Endoscopy of Ribeirao Preto Medical School, University of Sao Paulo en Google Maps
Suspendido1 Centros de Estudio