Prospective, Multi-Center, Observational Program to Assess Routine Use of Add-back Therapy in Patients With Endometriosis in Russian Federation, Planned for 6-month Course of Gonadoliberin Agonist Lucrin Depot.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 391
- 试验地点
- 28
- 主要终点
- Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment
研究概览
简要总结
The purpose of this study is to assess rates of administration of add-back therapy in patients with endometriosis in the Russian Federation, during a 6-month course of gonadoliberin agonist leuprorelin 3.75 mg.
详细描述
This was a non-interventional, observational program in which Lucrin Depot (leuprorelin acetate) and add-back therapy (hormone and non-hormone) were prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication (for leuprorelin acetate) and with regards to the local guidelines or therapeutic recommendation (for add-back therapy).
The rationale for the study was the necessity to characterize the patient population and long-term leuprorelin acetate administration in the Russian Federation. Further, it was important to characterize the compliance, tolerability, and safety profile of this therapy in the routine clinical care setting in the Russian Federation.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 50 years
- •Written Patient Consent for Use/Disclosure of Data
- •Diagnosis of genital endometriosis confirmed by laparoscopy (external genital endometriosis) or ultrasound (internal genital endometriosis)
- •Candidate for treatment with Lucrin Depot for 6-month course
- •Patients with suspected endometriosis suffering from chronic pelvic pain if other reasons for pain are excluded
排除标准
- •Contraindications to administration of Lucrin Depot (leuprorelin):
- •Hypersensitivity to leuprorelin similar products of protein origin or any of the excipients in drug product composition
- •Vaginal bleedings of unknown etiology
- •Hysterectomy
- •Pregnancy and lactation
- •Menopause (absence of cyclic menstrual hemorrhages for 1 year before the start of this program)
- •Acute infectious period, inclusive of acute inflammatory diseases of small pelvic organs
- •Other contraindications that make the patients participation impossible (by investigator judgment)
- •Previous enrollment in the present program
- •Extra-genital endometriosis
结局指标
主要结局
Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment
时间窗: 6 months
The percentage of participants who received hormone add-back therapy or non-hormone add-back therapy to reduce estrogen deficiency symptom, following local guidelines or therapeutic recommendations, during the 6-month treatment period with leuprorelin.
次要结局
- Percent Compliance to Treatment With Leuprorelin(6 months)
- Participants With Estrogen Deficiency Symptoms(6 months)