Trial Outcomes & Findings for Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733) (NCT NCT01490190)
NCT ID: NCT01490190
Last Updated: 2024-05-24
Results Overview
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.
COMPLETED
PHASE4
252 participants
Up to 84 days (three 28-day cycles)
2024-05-24
Participant Flow
Participant milestones
| Measure |
NuvaRing: Safety Population
Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
|
|---|---|
|
Overall Study
STARTED
|
252
|
|
Overall Study
COMPLETED
|
204
|
|
Overall Study
NOT COMPLETED
|
48
|
Reasons for withdrawal
| Measure |
NuvaRing: Safety Population
Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Adverse Event
|
17
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Lost to Follow-up
|
13
|
|
Overall Study
Relocation
|
1
|
|
Overall Study
Inconvenience
|
1
|
|
Overall Study
Ring expulsion
|
2
|
Baseline Characteristics
Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733)
Baseline characteristics by cohort
| Measure |
NuvaRing: Safety Population
n=252 Participants
Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
|
|---|---|
|
Age, Continuous
|
29.5 Years
STANDARD_DEVIATION 5.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
252 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Per Protocol Population, which included all participants who completed the study as per protocol.
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.
Outcome measures
| Measure |
NuvaRing
n=204 Participants
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.
|
|---|---|
|
Number of Participants With Regular Menstrual Cycles
First cycle: Regular
|
192 Participants
|
|
Number of Participants With Regular Menstrual Cycles
First cycle: Irregular
|
9 Participants
|
|
Number of Participants With Regular Menstrual Cycles
First cycle: Missing data
|
3 Participants
|
|
Number of Participants With Regular Menstrual Cycles
Second cycle: Regular
|
199 Participants
|
|
Number of Participants With Regular Menstrual Cycles
Second cycle: Irregular
|
4 Participants
|
|
Number of Participants With Regular Menstrual Cycles
Second cycle: Missing data
|
1 Participants
|
|
Number of Participants With Regular Menstrual Cycles
Third cycle: Regular
|
200 Participants
|
|
Number of Participants With Regular Menstrual Cycles
Third cycle: Irregular
|
3 Participants
|
|
Number of Participants With Regular Menstrual Cycles
Third cycle: Missing data
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Per Protocol Population, which included all participants who completed the study as per protocol. Of the total Per Protocol Population (N = 204), data for this outcome measure were missing for 3 partcipants in the first cycle, 1 participant in the second cycle, and 1 participant in the third cycle.
Mean duration of menstruation, per day, per cycle, during the study period.
Outcome measures
| Measure |
NuvaRing
n=203 Participants
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.
|
|---|---|
|
Average Number of Bleeding Days Per Cycle
Second cycle (N = 203)
|
3.7 Days
Standard Deviation 1.13
|
|
Average Number of Bleeding Days Per Cycle
Third cycle (N = 203)
|
3.6 Days
Standard Deviation 0.98
|
|
Average Number of Bleeding Days Per Cycle
First cycle (N = 201)
|
3.8 Days
Standard Deviation 1.24
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Per Protocol Population, which included all participants who completed the study as per protocol. Of the total Per Protocol Population (N = 204), data for this outcome measure were missing for 3 partcipants in the first cycle, 1 participant in the second cycle, and 1 participant in the third cycle.
Intensity of menstruation, as indicated by the median number of pads used per day by participants during each cycle of NuvaRing use.
Outcome measures
| Measure |
NuvaRing
n=203 Participants
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.
|
|---|---|
|
Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring
First cycle (N = 201)
|
2 Pads
Interval 0.0 to 6.0
|
|
Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring
Second cycle (N = 203)
|
2 Pads
Interval 1.0 to 10.0
|
|
Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring
Third cycle (N = 203)
|
2 Pads
Interval 1.0 to 7.0
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Per Protocol Population, which included all participants who completed the study as per protocol.
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.
Outcome measures
| Measure |
NuvaRing
n=204 Participants
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.
|
|---|---|
|
Number of Participants With Intermenstrual Bleeding/Spotting
First cycle: Total bleeding/spotting
|
5 Participants
|
|
Number of Participants With Intermenstrual Bleeding/Spotting
First cycle: Bleeding
|
1 Participants
|
|
Number of Participants With Intermenstrual Bleeding/Spotting
First cycle: Spotting
|
4 Participants
|
|
Number of Participants With Intermenstrual Bleeding/Spotting
Second cycle: Total bleeding/spotting
|
0 Participants
|
|
Number of Participants With Intermenstrual Bleeding/Spotting
Second cycle: Bleeding
|
0 Participants
|
|
Number of Participants With Intermenstrual Bleeding/Spotting
Second cycle: Spotting
|
0 Participants
|
|
Number of Participants With Intermenstrual Bleeding/Spotting
Third cycle: Total bleeding/spotting
|
1 Participants
|
|
Number of Participants With Intermenstrual Bleeding/Spotting
Third cycle: Bleeding
|
0 Participants
|
|
Number of Participants With Intermenstrual Bleeding/Spotting
Third cycle: Spotting
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: One participant in Per Protocol Population who experienced vaginal bleeding was evaluated for duration of bleeding.
Intermenstrual vaginal bleeding that required \>=2 pads per day was classified as BLEEDING.
Outcome measures
| Measure |
NuvaRing
n=1 Participants
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.
|
|---|---|
|
Number of Bleeding Days Per Cycle
First cycle
|
4 Days
Standard Deviation 0
|
|
Number of Bleeding Days Per Cycle
Second cycle
|
0 Days
Standard Deviation 0
|
|
Number of Bleeding Days Per Cycle
Third cycle
|
0 Days
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Participants in the Per Protocol Population who experienced spotting were evaluated for duration of spotting.
Intermenstrual vaginal bleeding that required \<=1 pad per day was classified as SPOTTING.
Outcome measures
| Measure |
NuvaRing
n=5 Participants
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.
|
|---|---|
|
Number of Spotting Days Per Cycle
First cycle (N = 4)
|
5.5 Days
Standard Deviation 4.2
|
|
Number of Spotting Days Per Cycle
Second cycle (N = 0)
|
0 Days
Standard Deviation 0
|
|
Number of Spotting Days Per Cycle
Third cycle (N = 1)
|
3 Days
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Per Protocol Population, which included all participants who completed the study as per protocol.
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.
Outcome measures
| Measure |
NuvaRing
n=204 Participants
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.
|
|---|---|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
First cycle: Very easy
|
59 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
First cycle: Easy
|
82 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
First cycle: Neutral
|
59 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
First cycle: Difficult
|
4 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
First cycle: Very difficult
|
0 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
First cycle: Failed
|
0 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
Second cycle: Very easy
|
73 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
Second cycle: Easy
|
105 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
Second cycle: Neutral
|
20 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
Second cycle: Difficult
|
6 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
Second cycle: Very difficult
|
0 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
Second cycle: Failed
|
0 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
Third cycle: Very easy
|
78 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
Third cycle: Easy
|
113 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
Third cycle: Neutral
|
12 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
Third cycle: Difficult
|
1 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
Third cycle: Very difficult
|
0 Participants
|
|
Participants' Assessment of Ease of Insertion of Vaginal Ring
Third cycle: Failed
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Per Protocol Population, which included all participants who completed the study as per protocol.
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.
Outcome measures
| Measure |
NuvaRing
n=204 Participants
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.
|
|---|---|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
First cycle: Very easy
|
70 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
First cycle: Easy
|
128 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
First cycle: Neutral
|
6 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
First cycle: Difficult
|
0 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
First cycle: Very difficult
|
0 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
First cycle: Failed
|
0 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
Second cycle: Very easy
|
81 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
Second cycle: Easy
|
119 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
Second cycle: Neutral
|
4 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
Second cycle: Difficult
|
0 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
Second cycle: Very difficult
|
0 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
Second cycle: Failed
|
0 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
Third cycle: Very easy
|
88 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
Third cycle: Easy
|
113 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
Third cycle: Neutral
|
2 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
Third cycle: Difficult
|
1 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
Third cycle: Very different
|
0 Participants
|
|
Participants' Assessment of Ease of Removal of Vaginal Ring
Third cycle: Failed
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Per Protocol Population, which included all participants who completed the study as per protocol.
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.
Outcome measures
| Measure |
NuvaRing
n=204 Participants
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.
|
|---|---|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
First cycle: Never
|
87 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
First cycle: Rarely
|
89 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
First cycle: Occasionally
|
25 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
First cycle: Mostly
|
1 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
First cycle: Always
|
2 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
Second cycle: Never
|
107 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
Second cycle: Rarely
|
86 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
Second cycle: Occasionally
|
8 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
Second cycle: Mostly
|
2 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
Second cycle: Always
|
1 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
Third cycle: Never
|
117 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
Third cycle: Rarely
|
79 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
Third cycle: Occasionally
|
5 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
Third cycle: Mostly
|
3 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring at Any Time
Third cycle: Always
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Per Protocol Population, which included all participants who completed the study as per protocol.
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.
Outcome measures
| Measure |
NuvaRing
n=204 Participants
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.
|
|---|---|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
First cycle: Never
|
85 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
First cycle: Rarely
|
81 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
First cycle: Occasionally
|
33 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
First cycle: Mostly
|
3 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
First cycle: Always
|
2 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
Second cycle: Never
|
100 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
Second cycle: Rarely
|
82 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
Second cycle: Occasionally
|
21 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
Second cycle: Mostly
|
0 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
Second cycle: Always
|
1 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
Third cycle: Never
|
125 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
Third cycle: Rarely
|
69 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
Third cycle: Occasionally
|
9 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
Third cycle: Mostly
|
0 Participants
|
|
Participants' Assessment of Feeling Vaginal Ring During Intercourse
Third cycle: Always
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Per Protocol Population, which included all participants who completed the study as per protocol.
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.
Outcome measures
| Measure |
NuvaRing
n=204 Participants
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.
|
|---|---|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
First cycle: Never
|
88 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
First cycle: Rarely
|
75 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
First cycle: Occasionally
|
34 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
First cycle: Mostly
|
5 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
First cycle: Always
|
2 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
Second cycle: Never
|
112 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
Second cycle: Rarely
|
65 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
Second cycle: Occasionally
|
23 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
Second cycle: Mostly
|
3 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
Second cycle: Always
|
1 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
Third cycle: Never
|
121 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
Third cycle: Rarely
|
69 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
Third cycle: Occasionally
|
10 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
Third cycle: Mostly
|
3 Participants
|
|
Frequency of Partner Feeling Vaginal Ring During Intercourse
Third cycle: Always
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Per Protocol Population, which included all participants who completed the study as per protocol.
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.
Outcome measures
| Measure |
NuvaRing
n=204 Participants
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.
|
|---|---|
|
Frequency of Partner Objecting to Vaginal Ring Use
Third cycle: Occasionally
|
3 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
Third cycle: Mostly
|
3 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
Third cycle: Always
|
0 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
First cycle: Never
|
129 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
First cycle: Rarely
|
70 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
First cycle: Occasionally
|
4 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
First cycle: Mostly
|
1 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
First cycle: Always
|
0 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
Second cycle: Never
|
143 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
Second cycle: Rarely
|
55 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
Second cycle: Occasionally
|
5 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
Second cycle: Mostly
|
1 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
Second cycle: Always
|
0 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
Third cycle: Never
|
153 Participants
|
|
Frequency of Partner Objecting to Vaginal Ring Use
Third cycle: Rarely
|
45 Participants
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
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.
Outcome measures
| Measure |
NuvaRing
n=252 Participants
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.
|
|---|---|
|
Participants' Overall Satisfaction With Vaginal Ring
Second cycle (N = 213): Unsatisfied
|
1 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
Second cycle (N = 213): Very unsatisfied
|
0 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
Second cycle (N = 213): Missing data
|
3 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
Third cycle (N = 207): Very satisfied
|
88 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
First cycle (N = 252): Very satisfied
|
68 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
First cycle (N = 252): Satisfied
|
119 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
First cycle (N = 252): Neutral
|
28 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
First cycle (N = 252): Very unsatisfied
|
1 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
First cycle (N = 252): Missing data
|
27 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
Second cycle (N = 213): Very satisfied
|
82 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
Second cycle (N = 213): Satisfied
|
112 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
Second cycle(N = 213): Neutral
|
15 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
Third cycle (N = 207): Satisfied
|
107 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
Third cycle (N = 207): Neutral
|
9 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
Third cycle (N = 207): Unsatisfied
|
1 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
Third cycle (N = 207): Very unsatisfied
|
1 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
Third cycle (N = 207): Missing data
|
1 Participants
|
|
Participants' Overall Satisfaction With Vaginal Ring
First cycle (N = 252): Unsatisfied
|
9 Participants
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
Participants were asked at follow-up visits after every cycle whether they planned to continue using NuvaRing, and their answers were recorded.
Outcome measures
| Measure |
NuvaRing
n=252 Participants
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.
|
|---|---|
|
Number of Participants Who Plan to Continue Using Vaginal Ring
First cycle (N = 252): Yes
|
216 Participants
|
|
Number of Participants Who Plan to Continue Using Vaginal Ring
First cycle (N = 252): No
|
9 Participants
|
|
Number of Participants Who Plan to Continue Using Vaginal Ring
First cycle (N = 252): Missing data
|
27 Participants
|
|
Number of Participants Who Plan to Continue Using Vaginal Ring
Second cycle (N = 213): Yes
|
205 Participants
|
|
Number of Participants Who Plan to Continue Using Vaginal Ring
Second cycle (N = 213): No
|
5 Participants
|
|
Number of Participants Who Plan to Continue Using Vaginal Ring
Second cycle (N = 213): Missing data
|
3 Participants
|
|
Number of Participants Who Plan to Continue Using Vaginal Ring
Third cycle (N = 207): Yes
|
159 Participants
|
|
Number of Participants Who Plan to Continue Using Vaginal Ring
Third cycle (N = 207): No
|
47 Participants
|
|
Number of Participants Who Plan to Continue Using Vaginal Ring
Third cycle (N = 207): Missing data
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
Participants were asked at follow-up visits after every cycle whether they would recommend NuvaRing to other women, and their answers were reported.
Outcome measures
| Measure |
NuvaRing
n=252 Participants
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.
|
|---|---|
|
Number of Participants Who Would Recommend Vaginal Ring to Others
First cycle (N = 252): Yes
|
208 Participants
|
|
Number of Participants Who Would Recommend Vaginal Ring to Others
First cycle (N = 252): No
|
16 Participants
|
|
Number of Participants Who Would Recommend Vaginal Ring to Others
First cycle (N = 252): Missing data
|
28 Participants
|
|
Number of Participants Who Would Recommend Vaginal Ring to Others
Second cycle (N = 213): Yes
|
197 Participants
|
|
Number of Participants Who Would Recommend Vaginal Ring to Others
Second cycle (N = 213): No
|
13 Participants
|
|
Number of Participants Who Would Recommend Vaginal Ring to Others
Second cycle (N = 213): Missing data
|
3 Participants
|
|
Number of Participants Who Would Recommend Vaginal Ring to Others
Third cycle (N = 207): Yes
|
193 Participants
|
|
Number of Participants Who Would Recommend Vaginal Ring to Others
Third cycle (N = 207): No
|
13 Participants
|
|
Number of Participants Who Would Recommend Vaginal Ring to Others
Third cycle (N = 207): Missing data
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
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.
Outcome measures
| Measure |
NuvaRing
n=252 Participants
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.
|
|---|---|
|
Number of Pregnancies Due to Contraceptive Method Failure During the Study
First cycle (N = 252): Yes
|
0 Pregnancies
|
|
Number of Pregnancies Due to Contraceptive Method Failure During the Study
First cycle (N = 252): No
|
226 Pregnancies
|
|
Number of Pregnancies Due to Contraceptive Method Failure During the Study
First cycle (N = 252): Missing data
|
26 Pregnancies
|
|
Number of Pregnancies Due to Contraceptive Method Failure During the Study
Second cycle (N = 213): Yes
|
0 Pregnancies
|
|
Number of Pregnancies Due to Contraceptive Method Failure During the Study
Second cycle (N = 213): No
|
210 Pregnancies
|
|
Number of Pregnancies Due to Contraceptive Method Failure During the Study
Second cycle (N = 213): Missing data
|
3 Pregnancies
|
|
Number of Pregnancies Due to Contraceptive Method Failure During the Study
Third cycle (N = 207): Yes
|
0 Pregnancies
|
|
Number of Pregnancies Due to Contraceptive Method Failure During the Study
Third cycle (N = 207): No
|
207 Pregnancies
|
|
Number of Pregnancies Due to Contraceptive Method Failure During the Study
Third cycle (N = 207): Missing data
|
0 Pregnancies
|
SECONDARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
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.
Outcome measures
| Measure |
NuvaRing
n=252 Participants
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.
|
|---|---|
|
Number of Participants Who Reported at Least One Adverse Event During the Study
|
47 Participants
|
SECONDARY outcome
Timeframe: Up to 84 days (three 28-day cycles)Population: Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
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.
Outcome measures
| Measure |
NuvaRing
n=252 Participants
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.
|
|---|---|
|
Number of Participants Who Reported a Serious Adverse Event During the Study
|
0 Participants
|
Adverse Events
NuvaRing: Safety Population
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NuvaRing: Safety Population
n=252 participants at risk
Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
|
|---|---|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.2%
13/252 • Number of events 13 • Up to 84 days (three 28-day cycles)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee The principal investigator agrees not to publish or publicly present interim results of the Study without prior written consent of sponsor, agrees to provide 45 days written notice to sponsor prior to submission for publication or presentation, and permits sponsor to review copies of abstracts and manuscripts for publication, and slides and text of oral presentations and text of any electronically transmitted media such as the Internet, World Wide Web, etc.
- Publication restrictions are in place
Restriction type: OTHER