An Observational, Prospective, Multicentre Study to Assess the Sensitivity to Change of the SAMANTA Questionnaire in Women with Heavy Menstrual Bleeding (HMB)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 422
- 试验地点
- 1
- 主要终点
- SAMANTA questionnaire score
研究概览
简要总结
A study run at multiple study sites in Spain to test whether the SAMANTA questionnaire that is used to diagnose heavy menstrual bleeding (HMB), can also be used to assess changes of severity of HMB in women with HMB who are treated during 12 months with a chronic hormonal treatment. Patients that are treated with chronic hormonal treatment as Levonorgestrel (trade name Mirena) or with a combination of estradiol valerate and dienogest (trade name Qlaira) or with Medroxyprogesterone acetate (trade name Progevera) and any new hormonal treatment marketed in Spain that has the indication for HMB in routine gynaecological practice are observed for 12 months in this study or for a shorter period in time in case of withdrawal. The study aims also to describe the overall satisfaction of women with their chronic hormonal treatment for HMB and how the women think their menstrual bleeding has changed. In addition the study aims to describe the changes of the score that is derived from the SAMANTA questionnaire in relation to Quality of Life. Quality of Life is measured with the SF36v2 questionnaire. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
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
- •Women in childbearing age, ≥18 years old, not intending to become pregnant during the next year.
- •Women diagnosed with heavy menstrual bleeding or idiopathic menorrhagia according to medical criteria and based on clinical judgment.
- •Women for whom the clinician decides, in agreement with the patient, to prescribe any of the available chronic hormonal treatments with the therapeutic indication of HMB in Spain (Mirena, Qlaira or Progevera).
- •Women capable of reading and writing.
- •Women who signed the informed consent.
排除标准
- •Women with amenorrhea or menopause.
- •Women with contraindications and warnings with the chronic hormonal treatment prescribed for HMB as per the summary of product characteristics (interaction with concomitant medication, etc.).
- •Women receiving contraceptive hormonal therapy or using a copper intrauterine device.
- •Women on hormone replacement therapy.
- •Women with a history of malignancy.
- •Women with degenerative diseases that could directly negatively impact their daily life.
- •Women who have given birth within the previous 6 months.
- •Women who are pregnant.
- •Women participating in an investigational program with interventions outside of routine clinical practice.
- •Women with psychiatric disorders who are unable to make decisions and follow instructions.
- •Women with concomitant medication that may lead to changes in the bleeding pattern (e.g. antiplatelet and/ or anticoagulants).
研究组 & 干预措施
Women with HMB
Women with a diagnostic of HMB according to medical criteria and based on clinical judgment that have freely chosen a chronic hormonal treatment under therapeutic indication of HMB in Spain
干预措施: Chronic hormonal treatment (Drug)
结局指标
主要结局
SAMANTA questionnaire score
时间窗: Up to 12 months
SAMANTA questionnaire: is a existing and validated tool has shown that it can be effectively used by gynaecologists to easily discriminate among women with and without HMB
次要结局
- Changes in menstrual bleeding pattern measured with a user satisfaction questionnaire(Up to 12 months)
- Overall satisfaction with the chronic hormonal treatment measured with a user satisfaction questionnaire(Up to 12 months)
- Correlation between changes in SAMANTA score and changes in women's quality of life measured with SF36v2 questionnaire(Up to 12 months)