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This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be assessed and compared with that of Yasmin.
The purpose of this study is to assess the contraceptive efficacy of NuvaRing in fertile Chinese women; to assess vaginal bleeding pattern (cycle control), general safety, and acceptability of NuvaRing; and to evaluate the NuvaRing's effect on dysmenorrhea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENG-EE (NuvaRing) | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENG 120 µg + EE 15 µg intravaginal ring | Drug | 13 cycles of ENG-EE (NuvaRing) vaginal ring use. Each cycle 28 days, with a 21-day active treatment period followed by 7-day ring-free period. One ring per cycle, each ring containing 11.7 mg ENG and 2.7 mg EE, and releasing on average 120 mcg/day of ENG and 15 mcg/day of EE. |
| Measure | Description | Time Frame |
|---|---|---|
| Pearl Index, by Treatment Group | 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). | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27339759 | Result | Fan GS, Ren M, Di W, Su P, Chang Q, Wu S, Qin Y, Korver T, Marintcheva-Petrova M, Yacik C, McCrary Sisk C, Wang G. Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial. Eur J Contracept Reprod Health Care. 2016 Aug;21(4):303-9. doi: 10.1080/13625187.2016.1186269. Epub 2016 Jun 24. |
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Of the 983 participants randomized, 946 received treatment and 37 discontinued prior to receiving treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Subjects Treated (AST) group, which consisted of all randomized participants who used at least one ring/pill.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pearl Index, by Treatment Group | 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). | 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). | Posted | Mean | 95% Confidence Interval | Pregnancies per 100 woman-years | Up to 1 year |
|
Up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharpe & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000071063 | Endoglin |
| C516519 | NuvaRing |
| C035144 | drospirenone |
| C534342 | drospirenone and ethinyl estradiol combination |
| ID | Term |
|---|---|
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
|
| DRSP 3 mg + EE 30 µg | Drug | 13 cycles of DRSP-EE tablet use. Each cycle 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received total of 21 tablets per cycle, each tablet contained 3 mg DRSP and 30 μg EE. |
|
|
| Up to 1 year |
| Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle | 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. | Up to 1 year |
| Lost to Follow-up |
|
| Did not wish to continue |
|
| Withdrew Consent |
|
| Non-compliance with protocol |
|
| Did not meet protocol eligibility |
|
| Administrative |
|
| Pregnancy wish |
|
| Discontinued prior to treatment |
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| Secondary | Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle | 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. | ITT Group, which consisted of all randomized participants who used at least one ring/pill. | Posted | Number | Percentage of participants | Up to 1 year |
|
|
|
|
| Secondary | Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle | 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. | ITT Group, which consisted of all randomized participants who used at least one ring/pill. | Posted | Number | Percentage of participants | Up to 1 year |
|
|
|
|
| 2 |
| 714 |
| 0 |
| 714 |
| EG001 | 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. | 4 | 232 | 0 | 232 |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 16.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
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.
| Cycle 3 (n=578,196) |
|
| Cycle 4 (n=587,194) |
|
| Cycle 5 (n=592,187) |
|
| Cycle 6 (n=590,185) |
|
| Cycle 7 (n=583,186) |
|
| Cycle 8 (n=585,188) |
|
| Cycle 9 (n=576,187) |
|
| Cycle 10 (n=572,183) |
|
| Cycle 11 (n=578,177) |
|
| Cycle 12 (n=569,176) |
|
| Cycle 13 (n=544,173) |
|
For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
| Miettinen and Nurminen method |
| 0.029 |
| Difference in Percentages, Cycle 2 |
| -6.2 |
| 2-Sided |
| 95 |
| -12.7 |
| -0.6 |
| Superiority or Other (legacy) |
| For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.019 | Difference in Percentages, Cycle 3 | -5.8 | 2-Sided | 95 | -11.8 | -0.9 | Superiority or Other (legacy) |
| For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.001 | Difference in Percentages, Cycle 4 | -8.0 | 2-Sided | 95 | -14.0 | -2.9 | Superiority or Other (legacy) |
| For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.556 | Difference in Percentages, Cycle 5 | -1.3 | 2-Sided | 95 | -6.4 | 2.6 | Superiority or Other (legacy) |
| For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.089 | Difference in Percentages, Cycle 6 | -3.9 | 2-Sided | 95 | -9.5 | 0.5 | Superiority or Other (legacy) |
| For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.110 | Difference in Percentages, Cycle 7 | -3.7 | 2-Sided | 95 | -9.4 | 0.8 | Superiority or Other (legacy) |
| For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.049 | Difference in Percentages, Cycle 8 | -4.3 | 2-Sided | 95 | -9.8 | -0.0 | Superiority or Other (legacy) |
| For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.621 | Difference in Percentages, Cycle 9 | -1.1 | 2-Sided | 95 | -6.2 | 2.9 | Superiority or Other (legacy) |
| For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.041 | Difference in Percentages, Cycle 10 | -4.4 | 2-Sided | 95 | -10.0 | -0.2 | Superiority or Other (legacy) |
| For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.046 | Difference in Percentages, Cycle 11 | -3.8 | 2-Sided | 95 | -8.9 | -0.1 | Superiority or Other (legacy) |
| For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.037 | Difference in Percentages, Cycle 12 | -4.4 | 2-Sided | 95 | -9.9 | -0.2 | Superiority or Other (legacy) |
| For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.048 | Difference in Percentages, Cycle 13 | -4.5 | 2-Sided | 95 | -10.4 | -0.0 | Superiority or Other (legacy) |
| Cycle 3 (n=577,196) |
|
| Cycle 4 (n=586,194) |
|
| Cycle 5 (n=590,187) |
|
| Cycle 6 (n=588,185) |
|
| Cycle 7 (n=581,186) |
|
| Cycle 8 (n=583,188) |
|
| Cycle 9 (n=575,187) |
|
| Cycle 10 (n=571,183) |
|
| Cycle 11 (n=576,177) |
|
| Cycle 12 (n=568,176) |
|
| Cycle 13 (n=543,173) |
|
For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.
| Miettinen and Nurminen method |
| 0.012 |
| Difference in Percentages, Cycle 2 |
| -4.9 |
| 2-Sided |
| 95 |
| -10.1 |
| -1.0 |
| Superiority or Other (legacy) |
| For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.002 | Difference in Percentages, Cycle 3 | -6.5 | 2-Sided | 95 | -12.0 | -2.2 | Superiority or Other (legacy) |
| For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.044 | Difference in Percentages, Cycle 4 | -3.6 | 2-Sided | 95 | -8.5 | -0.1 | Superiority or Other (legacy) |
| For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.609 | Difference in Percentages, Cycle 5 | -1.0 | 2-Sided | 95 | -5.7 | 2.5 | Superiority or Other (legacy) |
| For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.062 | Difference in Percentages, Cycle 6 | -3.9 | 2-Sided | 95 | -9.3 | 0.2 | Superiority or Other (legacy) |
| For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.019 | Difference in Percentages, Cycle 7 | -4.1 | 2-Sided | 95 | -9.0 | -0.6 | Superiority or Other (legacy) |
| For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.308 | Difference in Percentages, Cycle 8 | -1.9 | 2-Sided | 95 | -6.7 | 1.6 | Superiority or Other (legacy) |
| For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.027 | Difference in Percentages, Cycle 9 | -4.2 | 2-Sided | 95 | -9.3 | -0.4 | Superiority or Other (legacy) |
| For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.098 | Difference in Percentages, Cycle 10 | -2.9 | 2-Sided | 95 | -7.6 | 0.5 | Superiority or Other (legacy) |
| For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.009 | Difference in Percentages, Cycle 11 | -4.4 | 2-Sided | 95 | -9.4 | -1.0 | Superiority or Other (legacy) |
| For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.002 | Difference in Percentages, Cycle 12 | -6.2 | 2-Sided | 95 | -11.7 | -2.1 | Superiority or Other (legacy) |
| For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen. | Miettinen and Nurminen method | 0.043 | Difference in Percentages, Cycle 13 | -4.5 | 2-Sided | 95 | -10.2 | -0.1 | Superiority or Other (legacy) |