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

• Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing) (Drug), also known as NuvaRing, SCH 900702: 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.

Primary outcomes

• Number of Participants With Regular Menstrual Cycles [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 Bleeding Days Per Cycle [Up to 84 days (three 28-day cycles)]: Mean duration of menstruation, per day, per cycle, during the study period.
• Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring [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 Participants With Intermenstrual Bleeding/Spotting [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.
• Number of Bleeding Days Per Cycle [Up to 84 days (three 28-day cycles)]: Intermenstrual vaginal bleeding that required >=2 pads per day was classified as BLEEDING.
• Number of Spotting Days Per Cycle [Up to 84 days (three 28-day cycles)]: Intermenstrual vaginal bleeding that required <=1 pad per day was classified as SPOTTING.
• Participants' Assessment of Ease of Insertion of Vaginal Ring [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 [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.
• Participants' Assessment of Feeling Vaginal Ring at Any Time [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.
• Participants' Assessment of Feeling Vaginal Ring During Intercourse [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.
• Frequency of Partner Feeling Vaginal Ring During Intercourse [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 [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.
• Participants' Overall Satisfaction With Vaginal Ring [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.
• Number of Participants Who Plan to Continue Using Vaginal Ring [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.
• Number of Participants Who Would Recommend Vaginal Ring to Others [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.

Secondary outcomes

• Number of Pregnancies Due to Contraceptive Method Failure During the Study [Up to 84 days (three 28-day cycles)]: 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.
• Number of Participants Who Reported at Least One Adverse Event During the Study [Up to 84 days (three 28-day cycles)]: 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.
• Number of Participants Who Reported a Serious Adverse Event During the Study [Up to 84 days (three 28-day cycles)]: 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.

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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

Participant flow

Outcome results

• Number of Participants With Regular Menstrual Cycles (Primary), Number, Participants: NuvaRing 192
• Average Number of Bleeding Days Per Cycle (Primary), Mean, Days: NuvaRing 3.8 +/- 1.24
• Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring (Primary), Median, Pads: NuvaRing 2 (0 to 6)
• Number of Participants With Intermenstrual Bleeding/Spotting (Primary), Number, Participants: NuvaRing 5
• Number of Bleeding Days Per Cycle (Primary), Mean, Days: NuvaRing 4 +/- 0
• Number of Spotting Days Per Cycle (Primary), Mean, Days: NuvaRing 5.5 +/- 4.2
• Participants' Assessment of Ease of Insertion of Vaginal Ring (Primary), Number, Participants: NuvaRing 59
• Participants' Assessment of Ease of Removal of Vaginal Ring (Primary), Number, Participants: NuvaRing 70
• Participants' Assessment of Feeling Vaginal Ring at Any Time (Primary), Number, Participants: NuvaRing 87
• Participants' Assessment of Feeling Vaginal Ring During Intercourse (Primary), Number, Participants: NuvaRing 85
• Frequency of Partner Feeling Vaginal Ring During Intercourse (Primary), Number, Participants: NuvaRing 88
• Frequency of Partner Objecting to Vaginal Ring Use (Primary), Number, Participants: NuvaRing 129
• Participants' Overall Satisfaction With Vaginal Ring (Primary), Number, Participants: NuvaRing 68
• Number of Participants Who Plan to Continue Using Vaginal Ring (Primary), Number, Participants: NuvaRing 216
• Number of Participants Who Would Recommend Vaginal Ring to Others (Primary), Number, Participants: NuvaRing 208
• Number of Pregnancies Due to Contraceptive Method Failure During the Study (Secondary), Number, Pregnancies: NuvaRing 0
• Number of Participants Who Reported at Least One Adverse Event During the Study (Secondary), Number, Participants: NuvaRing 47
• Number of Participants Who Reported a Serious Adverse Event During the Study (Secondary), Number, Participants: NuvaRing 0

Adverse events

Time frame: Up to 84 days (three 28-day cycles)

Other adverse events by term