Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733)

Study Overview
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Brief Summary
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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.

Official Title
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Contraceptive Vaginal Ring Releasing Etonogestrel and Ethinylestradiol (NuvaRing): Cycle Control, Acceptability and Tolerability Study in Indian Women

Conditions
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Contraception

Intervention / Treatment
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* Drug: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women at risk of pregnancy and seeking contraception Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NuvaRing<br> | Drug: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)<br>* Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.<br>* Other names: SCH 900702;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Regular Menstrual 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. | Up to 84 days (three 28-day cycles) | 
| Average Number of Bleeding Days Per Cycle | Mean duration of menstruation, per day, per cycle, during the study period. | Up to 84 days (three 28-day cycles) | 
| Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring | Intensity of menstruation, as indicated by the median number of pads used per day by participants during each cycle of NuvaRing use. | Up to 84 days (three 28-day cycles) | 
| Number of Participants With Intermenstrual Bleeding/Spotting | 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. | Up to 84 days (three 28-day cycles) | 
| Number of Bleeding Days Per Cycle | Intermenstrual vaginal bleeding that required >=2 pads per day was classified as BLEEDING. | Up to 84 days (three 28-day cycles) | 
| Number of Spotting Days Per Cycle | Intermenstrual vaginal bleeding that required <=1 pad per day was classified as SPOTTING. | Up to 84 days (three 28-day cycles) | 
| Participants' Assessment of Ease of Insertion of Vaginal Ring | 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. | Up to 84 days (three 28-day cycles) | 
| Participants' Assessment of Ease of Removal of Vaginal Ring | 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. | Up to 84 days (three 28-day cycles) | 
| Participants' Assessment of Feeling Vaginal Ring at Any Time | 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. | Up to 84 days (three 28-day cycles) | 
| Participants' Assessment of Feeling Vaginal Ring During Intercourse | 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. | Up to 84 days (three 28-day cycles) | 
| Frequency of Partner Feeling Vaginal Ring During Intercourse | 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. | Up to 84 days (three 28-day cycles) | 
| Frequency of Partner Objecting to Vaginal Ring Use | 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. | Up to 84 days (three 28-day cycles) | 
| Participants' Overall Satisfaction With Vaginal Ring | 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. | Up to 84 days (three 28-day cycles) | 
| Number of Participants Who Plan to Continue Using Vaginal Ring | Participants were asked at follow-up visits after every cycle whether they planned to continue using NuvaRing, and their answers were recorded. | Up to 84 days (three 28-day cycles) | 
| Number of Participants Who Would Recommend Vaginal Ring to Others | Participants were asked at follow-up visits after every cycle whether they would recommend NuvaRing to other women, and their answers were reported. | Up to 84 days (three 28-day cycles) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Reported a Serious Adverse Event During the Study | A serious adverse event is any adverse drug or biologic or device experience that results in death, a life-threatening adverse event, persistent or significant disability or incapacity; requires in-patient hospitalization, or prolonged hospitalization; or causes a congenital anomaly or birth defect. | Up to 84 days (three 28-day cycles) | 
| Number of Pregnancies Due to Contraceptive Method Failure During the Study | For participants with suspected pregnancy during in-treatment period, pregnancy was to be confirmed by hCG qualitative analysis using strip and/or other test(s) at the discretion of the treating physician. | Up to 84 days (three 28-day cycles) | 
| Number of Participants Who Reported at Least One Adverse Event During the Study | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic, or medical device, which does not necessarily have a causal relationship with the treatment. | Up to 84 days (three 28-day cycles) |