Trial Outcomes & Findings for A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450) (NCT NCT01277211)
NCT ID: NCT01277211
Last Updated: 2024-06-20
Results Overview
Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
983 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2024-06-20
Participant Flow
Of the 983 participants randomized, 946 received treatment and 37 discontinued prior to receiving treatment.
Participant milestones
| Measure |
ENG-EE (NuvaRing)
Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
|
DRSP-EE
Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
|
|---|---|---|
|
Overall Study
STARTED
|
738
|
245
|
|
Overall Study
Treated
|
714
|
232
|
|
Overall Study
COMPLETED
|
588
|
182
|
|
Overall Study
NOT COMPLETED
|
150
|
63
|
Reasons for withdrawal
| Measure |
ENG-EE (NuvaRing)
Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
|
DRSP-EE
Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
|
|---|---|---|
|
Overall Study
Adverse Event
|
60
|
22
|
|
Overall Study
Pregnancy
|
9
|
4
|
|
Overall Study
Lost to Follow-up
|
14
|
9
|
|
Overall Study
Did not wish to continue
|
17
|
0
|
|
Overall Study
Withdrew Consent
|
9
|
9
|
|
Overall Study
Non-compliance with protocol
|
13
|
4
|
|
Overall Study
Did not meet protocol eligibility
|
1
|
0
|
|
Overall Study
Administrative
|
3
|
0
|
|
Overall Study
Pregnancy wish
|
0
|
2
|
|
Overall Study
Discontinued prior to treatment
|
24
|
13
|
Baseline Characteristics
A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)
Baseline characteristics by cohort
| Measure |
ENG-EE (NuvaRing)
n=714 Participants
Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
|
DRSP-EE
n=232 Participants
Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
|
Total
n=946 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.8 Years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
31.2 Years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
31.7 Years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
714 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
946 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Restricted Intent-to-Treat (R-ITT) Group, which consisted of all participants from the Intent-to-Treat (ITT) Group who had at least one cycle at risk (no condom use and confirmed intercourse).
Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days).
Outcome measures
| Measure |
ENG-EE (NuvaRing)
n=662 Participants
Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
|
DRSP-EE
n=216 Participants
Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
|
|---|---|---|
|
Pearl Index, by Treatment Group
|
1.92 Pregnancies per 100 woman-years
Interval 0.92 to 3.53
|
3.12 Pregnancies per 100 woman-years
Interval 1.01 to 7.29
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: ITT Group, which consisted of all randomized participants who used at least one ring/pill.
Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required \>=2 pads/tampons per day was classified as BLEEDING. Vaginal bleeding that required \<=1 pad/tampon per day was classified as SPOTTING.
Outcome measures
| Measure |
ENG-EE (NuvaRing)
n=714 Participants
Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
|
DRSP-EE
n=232 Participants
Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
|
|---|---|---|
|
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Cycle 1 (n=598,199)
|
18.6 Percentage of participants
Interval 15.5 to 21.9
|
21.6 Percentage of participants
Interval 16.1 to 28.0
|
|
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Cycle 2 (n=604,195)
|
12.3 Percentage of participants
Interval 9.7 to 15.1
|
18.5 Percentage of participants
Interval 13.3 to 24.6
|
|
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Cycle 3 (n=578,196)
|
8.5 Percentage of participants
Interval 6.3 to 11.1
|
14.3 Percentage of participants
Interval 9.7 to 20.0
|
|
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Cycle 4 (n=587,194)
|
7.5 Percentage of participants
Interval 5.5 to 9.9
|
15.5 Percentage of participants
Interval 10.7 to 21.3
|
|
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Cycle 5 (n=592,187)
|
6.8 Percentage of participants
Interval 4.9 to 9.1
|
8.0 Percentage of participants
Interval 4.6 to 12.9
|
|
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Cycle 6 (n=590,185)
|
6.9 Percentage of participants
Interval 5.0 to 9.3
|
10.8 Percentage of participants
Interval 6.7 to 16.2
|
|
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Cycle 7 (n=583,186)
|
7.5 Percentage of participants
Interval 5.5 to 10.0
|
11.3 Percentage of participants
Interval 7.1 to 16.7
|
|
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Cycle 8 (n=585,188)
|
6.3 Percentage of participants
Interval 4.5 to 8.6
|
10.6 Percentage of participants
Interval 6.6 to 16.0
|
|
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Cycle 9 (n=576,187)
|
6.9 Percentage of participants
Interval 5.0 to 9.3
|
8.0 Percentage of participants
Interval 4.6 to 12.9
|
|
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Cycle 10 (n=572,183)
|
5.9 Percentage of participants
Interval 4.2 to 8.2
|
10.4 Percentage of participants
Interval 6.4 to 15.7
|
|
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Cycle 11 (n=578,177)
|
4.2 Percentage of participants
Interval 2.7 to 6.1
|
7.9 Percentage of participants
Interval 4.4 to 12.9
|
|
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Cycle 12 (n=569,176)
|
5.3 Percentage of participants
Interval 3.6 to 7.4
|
9.7 Percentage of participants
Interval 5.7 to 15.0
|
|
Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Cycle 13 (n=544,173)
|
6.4 Percentage of participants
Interval 4.5 to 8.8
|
11.0 Percentage of participants
Interval 6.7 to 16.6
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: ITT Group, which consisted of all randomized participants who used at least one ring/pill.
Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.
Outcome measures
| Measure |
ENG-EE (NuvaRing)
n=714 Participants
Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
|
DRSP-EE
n=232 Participants
Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
|
|---|---|---|
|
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Cycle 1 (n=596,199)
|
8.6 Percentage of participants
Interval 6.4 to 11.1
|
14.6 Percentage of participants
Interval 10.0 to 20.3
|
|
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Cycle 2 (n=602,195)
|
4.8 Percentage of participants
Interval 3.2 to 6.8
|
9.7 Percentage of participants
Interval 6.0 to 14.8
|
|
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Cycle 3 (n=577,196)
|
5.2 Percentage of participants
Interval 3.5 to 7.3
|
11.7 Percentage of participants
Interval 7.6 to 17.1
|
|
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Cycle 4 (n=586,194)
|
4.1 Percentage of participants
Interval 2.6 to 6.0
|
7.7 Percentage of participants
Interval 4.4 to 12.4
|
|
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Cycle 5 (n=590,187)
|
5.4 Percentage of participants
Interval 3.7 to 7.6
|
6.4 Percentage of participants
Interval 3.4 to 10.9
|
|
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Cycle 6 (n=588,185)
|
5.8 Percentage of participants
Interval 4.0 to 8.0
|
9.7 Percentage of participants
Interval 5.9 to 14.9
|
|
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Cycle 7 (n=581,186)
|
3.4 Percentage of participants
Interval 2.1 to 5.3
|
7.5 Percentage of participants
Interval 4.2 to 12.3
|
|
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Cycle 8 (n=583,188)
|
5.0 Percentage of participants
Interval 3.4 to 7.1
|
6.9 Percentage of participants
Interval 3.7 to 11.5
|
|
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Cycle 9 (n=575,187)
|
4.3 Percentage of participants
Interval 2.8 to 6.4
|
8.6 Percentage of participants
Interval 5.0 to 13.5
|
|
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Cycle 10 (n=571,183)
|
3.7 Percentage of participants
Interval 2.3 to 5.6
|
6.6 Percentage of participants
Interval 3.4 to 11.2
|
|
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Cycle 11 (n=576,177)
|
3.0 Percentage of participants
Interval 1.7 to 4.7
|
7.3 Percentage of participants
Interval 4.0 to 12.2
|
|
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Cycle 12 (n=568,176)
|
4.0 Percentage of participants
Interval 2.6 to 6.0
|
10.2 Percentage of participants
Interval 6.2 to 15.7
|
|
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Cycle 13 (n=543,173)
|
5.9 Percentage of participants
Interval 4.1 to 8.2
|
10.4 Percentage of participants
Interval 6.3 to 15.9
|
Adverse Events
ENG-EE (NuvaRing)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
DRSP-EE
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ENG-EE (NuvaRing)
n=714 participants at risk
Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
|
DRSP-EE
n=232 participants at risk
Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
|
|---|---|---|
|
Infections and infestations
Sinusitis
|
0.14%
1/714 • Number of events 1 • Up to 1 year
|
0.00%
0/232 • Up to 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.14%
1/714 • Number of events 1 • Up to 1 year
|
0.00%
0/232 • Up to 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/714 • Up to 1 year
|
0.43%
1/232 • Number of events 1 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/714 • Up to 1 year
|
0.86%
2/232 • Number of events 2 • Up to 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/714 • Up to 1 year
|
0.43%
1/232 • Number of events 1 • Up to 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharpe & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review and comment on data analysis and presentation for all abstracts, manuscripts, and slide presentations that report any results of this trial 45 days prior to the submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER