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
- 入组人数
- 252
- 主要终点
- Number of Participants With Regular Menstrual Cycles
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
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
研究组 & 干预措施
NuvaRing
干预措施: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing) (Drug)
结局指标
主要结局
Number of Participants With Regular Menstrual Cycles
时间窗: Up to 84 days (three 28-day cycles)
The number of participants who experienced regular menstrual bleeding patterns throughout the period of NuvaRing use. Bleeding patterns were to be characterized by particpants as regular or irregular.
Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring
时间窗: Up to 84 days (three 28-day cycles)
Intensity of menstruation, as indicated by the median number of pads used per day by participants during each cycle of NuvaRing use.
Number of Bleeding Days Per Cycle
时间窗: Up to 84 days (three 28-day cycles)
Intermenstrual vaginal bleeding that required \>=2 pads per day was classified as BLEEDING.
Participants' Assessment of Ease of Insertion of Vaginal Ring
时间窗: Up to 84 days (three 28-day cycles)
Participants were asked to classify their ability to insert the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.
Participants' Assessment of Ease of Removal of Vaginal Ring
时间窗: Up to 84 days (three 28-day cycles)
Participants were asked to classify their ability to remove the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.
Frequency of Partner Feeling Vaginal Ring During Intercourse
时间窗: Up to 84 days (three 28-day cycles)
Participants were asked if their partners could feel the NuvaRing during intercourse and to characterize their partners' experience as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.
Frequency of Partner Objecting to Vaginal Ring Use
时间窗: Up to 84 days (three 28-day cycles)
Participants were asked if their partners objected to their using the NuvaRing during intercourse and to characterize the frequency of their partners' objections as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.
Average Number of Bleeding Days Per Cycle
时间窗: Up to 84 days (three 28-day cycles)
Mean duration of menstruation, per day, per cycle, during the study period.
Number of Participants With Intermenstrual Bleeding/Spotting
时间窗: Up to 84 days (three 28-day cycles)
Number of participants who experienced vaginal bleeding, which includes BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. Vaginal bleeding that required \>=2 pads per day was classified as BLEEDING. Vaginal bleeding that required \<=1 pad per day was classified as SPOTTING.
Participants' Assessment of Feeling Vaginal Ring During Intercourse
时间窗: Up to 84 days (three 28-day cycles)
Participants were asked to assess whether they could feel the NuvaRing during intercourse and to characterize how often as one the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.
Number of Participants Who Plan to Continue Using Vaginal Ring
时间窗: Up to 84 days (three 28-day cycles)
Participants were asked at follow-up visits after every cycle whether they planned to continue using NuvaRing, and their answers were recorded.
Participants' Assessment of Feeling Vaginal Ring at Any Time
时间窗: Up to 84 days (three 28-day cycles)
Participants were asked to assess whether they could feel the NuvaRing at any time and to characterize how often as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.
Number of Participants Who Would Recommend Vaginal Ring to Others
时间窗: Up to 84 days (three 28-day cycles)
Participants were asked at follow-up visits after every cycle whether they would recommend NuvaRing to other women, and their answers were reported.
Number of Spotting Days Per Cycle
时间窗: Up to 84 days (three 28-day cycles)
Intermenstrual vaginal bleeding that required \<=1 pad per day was classified as SPOTTING.
Participants' Overall Satisfaction With Vaginal Ring
时间窗: Up to 84 days (three 28-day cycles)
Participants were asked to characterize their overall satisfaction with the NuvaRing as one of the following: very satisfied, satisfied, neutral, unsatisfied, or very unsatisfied. The number of participants who responded to each category was reported.
次要结局
- Number of Pregnancies Due to Contraceptive Method Failure During the Study(Up to 84 days (three 28-day cycles))
- Number of Participants Who Reported at Least One Adverse Event During the Study(Up to 84 days (three 28-day cycles))
- Number of Participants Who Reported a Serious Adverse Event During the Study(Up to 84 days (three 28-day cycles))