Investigating the inFluence of EndoMetriosis IN migraINE - FEMININE Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pattern of serum CGRP levels across menstrual phases
研究概览
简要总结
Migraine and endometriosis are common conditions that mainly affect females of reproductive age. Both can cause significant pain and have a strong impact on the quality of life. Increasing evidence suggests that these two conditions often occur together, and that females who have both may experience more severe symptoms than those with only one of them. However, the reasons why migraine and endometriosis are linked are still not well understood.
Some biological factors may help explain this connection. One of them is a molecule called calcitonin gene-related peptide (CGRP), which plays an important role in migraine and may also be involved in pain and inflammation in endometriosis. In addition, hormonal changes during the menstrual cycle, especially fluctuations in estrogen levels, may influence symptoms in both conditions. Genetic and epigenetic factors may also contribute to this association.
The main hypothesis of this study is that females who have both migraine and endometriosis have a distinct clinical and biological profile compared to females who have only migraine or only endometriosis. In particular, it is expected that differences will be observed in CGRP levels and hormonal patterns across the menstrual cycle.
The FEMININE study is a prospective observational study that will follow females over several menstrual cycles. It will include three groups: females with both migraine and endometriosis, females with migraine only, and females with endometriosis only. Participants will record their symptoms in diaries and will provide blood samples at specific times of the menstrual cycle.
The main goal of the study is to compare CGRP levels between groups. Additional goals include describing differences in symptoms, menstrual-related migraine, hormonal levels, and selected genetic and epigenetic markers.
By improving the understanding of how migraine and endometriosis are related, this study aims to support better diagnosis and more personalized care for females affected by these conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females (≥18 years old).
- •Diagnosis of migraine according to ICHD-3 criteria confirmed by a headache specialist (for MIG-O and MIG-EDM groups).
- •Confirmed diagnosis of endometriosis based on clinical symptoms and imaging or surgical criteria according to ESHRE guidelines (for EDM-O and MIG-EDM groups).
- •Signed informed consent.
排除标准
- •Individuals diagnosed with secondary headache according to the ICHD-
- •Individuals with a severe disease (e.g., major psychiatric disorder, severe cardiovascular conditions).
- •History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months.
- •Pregnant or breastfeeding females.
研究组 & 干预措施
Migraine and Endometriosis (MIG-EDM)
Females with a diagnosis of both migraine (ICHD-3 criteria) and endometriosis (ESHRE criteria)
Migraine Only (MIG-O)
Females with a diagnosis of migraine (ICHD-3 criteria) and no history of endometriosis.
Endometriosis Only (EDM-O)
Females with a diagnosis of endometriosis (ESHRE criteria) and no history of migraine.
结局指标
主要结局
Pattern of serum CGRP levels across menstrual phases
时间窗: During the first 3 menstrual cycles, up to 6 months if extension is needed
Serum CGRP levels measured during the periovulatory and perimenstrual phases and compared among females with comorbid migraine and endometriosis, migraine only, and endometriosis only.
次要结局
- Migraine frequency(Baseline through completion of follow-up, up to 6 months)
- Acute medication use(Baseline through completion of follow-up, up to 6 months)
- Migraine-related disability(Baseline and end of study, up to 6 months)
- Menstrually related migraine features(During follow-up, up to 6 months)
- Endometriosis-related quality of life(Baseline and end of study, up to 6 months)
- Endometriosis-related pain symptoms(Baseline through completion of follow-up, up to 6 months)
- Serum sex hormone levels(During predefined menstrual phases across follow-up, up to 6 months)
- Association between CGRP and hormonal levels(During follow-up, up to 6 months)
- Genetic markers(Baseline)
- Epigenetic markers(Baseline)