Phase IV study to assess the safety and effectiveness ofDienogest (Visanne®) amongst Indian women withEndometriosis, in real-world clinical practice: the VISAGEStudy
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 14
- 主要终点
- The primary objective in this study is:
研究概览
简要总结
Endometriosis is a chronic, progressive, estrogen-dependent disease of unknown aetiology, with a prevalence rate of up to 10% in women in reproductive age-group. Since there is no known cure for endometriosis, management is aimed at reducing pain, minimizing disease progression and preserving fertility. Dienogest is a progestin with both local and central effects in reducing endometriosis associated pelvic pain, with a good
safety profile. Based on the information from the clinical developmental program for Dienogest the Indian Health Authority (DCGI) has approved Dienogest for the management of pelvic pain associated with endometriosis and requested to carry out a phase IV post-approval study. The proposed regulatory postapproval Phase IV study is planned to assess the safety and effectiveness of Dienogest in patients in India with endometriosis associated pelvic pain, in real world clinical practice.
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
- •Female patients in India at least 18 years of age Clinical or surgical diagnosis of endometriosis: Clinical diagnosis by suggestive symptoms and positive finding in imaging study (Chocolate cyst) Patients diagnosed with endometriosis associated pelvic pain who have not been previously treated with Dienogest Decision to initiate treatment with Dienogest was made as per investigator’s routine treatment practice Signed informed consent.
排除标准
- •Participation in an investigational program with interventions outside of routine clinical practice Contra-indications according to the local summary of product characteristics (SPC).
结局指标
主要结局
The primary objective in this study is:
时间窗: 0 months, 3 months and 6 months
to assess the incidence of adverse events, in Indian Endometriosis patients on Dienogest therapy.
时间窗: 0 months, 3 months and 6 months
次要结局
- Change in endometriosis associated pelvic pain from baseline at six months, measured by 0-10(EAPP NRS.)