A, multicentre, prospective, open labeled phase IV study to evaluate safety andefficacy of Dienogest in patients suffering from endometriosis
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Safety
研究概览
简要总结
This is a, multicentre, prospective, open labeled phase IV study to evaluate safety and efficacy of Dienogest 2mg daily for 12 weeks (90 days) in patients suffering from endometriosis that will be conducted across various sites in India. The primary safety variables include:
1.Adverse events (based on severity grades, patterns, and causality)
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Serious adverse events (SAE; in terms of severity)
-
Clinically significant derangement in laboratory parameters
-
Clinically significant changes in vital signs, demographics, gynaecologic examination, breast examination, bleeding pattern (number of days, number of episodes, and duration of episodes with bleeding/spotting or spotting only)
Other safety variable are
Tolerability: The assessment of tolerability will be performed by the investigator based on investigator assessment questionnaire. The responses will be graded as “excellentâ€, “goodâ€, “fairâ€, and “not well toleratedâ€.
Efficacy
Primary variables
Clinical response: Clinical responses will be evaluated on the basis of changes in clinical sign/symptoms, lesion reduction and reduction in pain intensity in terms of dysmenorrhea and low back pain in endometriosis and are categorized as “cure†and “failureâ€. These are defined as follows:
1.Cure: Resolution of clinical signs and symptoms of original disease, not requiring further treatment
- Failure: Persistence of clinical signs and symptoms or worsening in signs and symptoms that required alternative treatment or death. To categorize as clinical failure at least three weeks of therapy should have been administered
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patients with a confirmed diagnosis of Endometriosis based on laparoscopy or imaging 2.Patients who receive a prescription of DIENOGEST according to the indication stated in the local approved SmPC.
- •3.Written informed consent signed by the patient or legally acceptable representative(s) in line with applicable re.gulation of country.
- •4.Planned treatment in line with the Summary of Product Characteristics, i.e. exclusion of all patients with contraindications.
排除标准
- •1.Exclusion of all patients with contraindications as per Investigators discretion.
结局指标
主要结局
Safety
时间窗: After end of treatment ie., 12 weeks (90 days)
of adverse events and change in laboratory tests.
时间窗: After end of treatment ie., 12 weeks (90 days)
The criteria for the assessment of safety and tolerability will be described in terms
时间窗: After end of treatment ie., 12 weeks (90 days)
1.Adverse events (based on severity grades, patterns, and causality).
时间窗: After end of treatment ie., 12 weeks (90 days)
2.Serious adverse events (SAE; in terms of severity)
时间窗: After end of treatment ie., 12 weeks (90 days)
3.Clinically significant derangement in lab results
时间窗: After end of treatment ie., 12 weeks (90 days)
4.Clinically significant changes in vital signs, demographics, gynaecologic
时间窗: After end of treatment ie., 12 weeks (90 days)
examination, breast examination, bleeding pattern.
时间窗: After end of treatment ie., 12 weeks (90 days)
次要结局
- Efficacy(Clinical response: Clinical responses will be evaluated on the basis of changes in)