Contraceptive vaginal ring releasing etonogestrel and ethinylestradiol (NuvaRing): Cycle control, acceptability and tolerability study in Indian women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- -Frequency of feeling ring at any time or during intercourse
研究概览
简要总结
This study will collect information on cycle control, acceptability and tolerability of the vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •There is no upper age limit specified for this study Women at risk of pregnancy and seeking contraception.
排除标准
- •Exclusion criteria based on approved prescribing information in India: Presence or history of venous thrombosis, with or without pulmonary embolism.
- •Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or transient ischemic attack).
- •Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
- •History of migraine with focal neurological symptoms.
- •Diabetes mellitus with vascular involvement.
- •The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (at the discretion of the doctors) Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
- •Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
- •Presence or history of liver tumors (benign or malignant).
- •Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid-influenced.
- •Undiagnosed vaginal bleeding.
- •Known or suspected pregnancy.
- •Hypersensitivity to the active substances or to any of the excipients of NuvaRing.
- •Women who are breast feeding.
结局指标
主要结局
-Frequency of feeling ring at any time or during intercourse
时间窗: 3 cycles (1 cycle is 28 days)
-Participants with regular menstrual cycles
时间窗: 3 cycles (1 cycle is 28 days)
-Participants overall satisfaction with ring
时间窗: 3 cycles (1 cycle is 28 days)
-Participants who plan to continue use of ring
时间窗: 3 cycles (1 cycle is 28 days)
-Participants with breakthrough bleeding/spotting
时间窗: 3 cycles (1 cycle is 28 days)
-Average number of bleeding days, pads used per day and bleeding/spotting days
时间窗: 3 cycles (1 cycle is 28 days)
-Assessment of ease of insertion and removal
时间窗: 3 cycles (1 cycle is 28 days)
-Frequency of partner feeling ring during intercourse or of objection to ring use
时间窗: 3 cycles (1 cycle is 28 days)
-Participants who would recommend ring
时间窗: 3 cycles (1 cycle is 28 days)
次要结局
- Number of pregnancy or pregnancies due to contraceptive method failure during the study(3 cycles (1 cycle is 28 days))
- Number of adverse events reported during the study(3 cycles (1 cycle is 28 days))
- Number of serious adverse events during the study(3 cycles (1 cycle is 28 days))