A Phase 3 interventional study of ENG 120 µg + EE 15 µg intravaginal ring and DRSP 3 mg + EE 30 µg in Contraception, sponsored by Organon and Co. Completed. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by Organon and Co · Phase 3, Interventional, and Prevention
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.
Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
Drug: ENG 120 µg + EE 15 µg intravaginal ring
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.
Drug: DRSP 3 mg + EE 30 µg
Drug page: NuvaRing
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.
Also known as: NuvaRing
Drug page: Drospirenone
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.
Also known as: Yasmin
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).
Time frame: Up to 1 year
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.
Time frame: 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.
Time frame: Up to 1 year
| Milestone | ENG-EE (NuvaRing) | DRSP-EE |
|---|---|---|
| Started | 738 | 245 |
| Treated | 714 | 232 |
| Completed | 588 | 182 |
| Not completed | 150 | 63 |
| Withdrew: Adverse event | 60 | 22 |
| Withdrew: Pregnancy | 9 | 4 |
| Withdrew: Lost to follow-up | 14 | 9 |
| Withdrew: Did not wish to continue | 17 | 0 |
| Withdrew: Withdrew consent | 9 | 9 |
| Withdrew: Non-compliance with protocol | 13 | 4 |
| Withdrew: Did not meet protocol eligibility | 1 | 0 |
| Withdrew: Administrative | 3 | 0 |
| Withdrew: Pregnancy wish | 0 | 2 |
| Withdrew: Discontinued prior to treatment | 24 | 13 |
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).
| Pregnancies per 100 woman-years | ENG-EE (NuvaRing) | DRSP-EE |
|---|---|---|
| Pearl Index, by Treatment Group | 1.92 (0.92 to 3.53) | 3.12 (1.01 to 7.29) |
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.
| Percentage of participants | ENG-EE (NuvaRing) | DRSP-EE |
|---|---|---|
| Cycle 1 (n=598,199) | 18.6 (15.5 to 21.9) | 21.6 (16.1 to 28.0) |
| Cycle 2 (n=604,195) | 12.3 (9.7 to 15.1) | 18.5 (13.3 to 24.6) |
| Cycle 3 (n=578,196) | 8.5 (6.3 to 11.1) | 14.3 (9.7 to 20.0) |
| Cycle 4 (n=587,194) | 7.5 (5.5 to 9.9) | 15.5 (10.7 to 21.3) |
| Cycle 5 (n=592,187) | 6.8 (4.9 to 9.1) | 8.0 (4.6 to 12.9) |
| Cycle 6 (n=590,185) | 6.9 (5.0 to 9.3) | 10.8 (6.7 to 16.2) |
| Cycle 7 (n=583,186) | 7.5 (5.5 to 10.0) | 11.3 (7.1 to 16.7) |
| Cycle 8 (n=585,188) | 6.3 (4.5 to 8.6) | 10.6 (6.6 to 16.0) |
| Cycle 9 (n=576,187) | 6.9 (5.0 to 9.3) | 8.0 (4.6 to 12.9) |
| Cycle 10 (n=572,183) | 5.9 (4.2 to 8.2) | 10.4 (6.4 to 15.7) |
| Cycle 11 (n=578,177) | 4.2 (2.7 to 6.1) | 7.9 (4.4 to 12.9) |
| Cycle 12 (n=569,176) | 5.3 (3.6 to 7.4) | 9.7 (5.7 to 15.0) |
| Cycle 13 (n=544,173) | 6.4 (4.5 to 8.8) | 11.0 (6.7 to 16.6) |
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.
| Percentage of participants | ENG-EE (NuvaRing) | DRSP-EE |
|---|---|---|
| Cycle 1 (n=596,199) | 8.6 (6.4 to 11.1) | 14.6 (10.0 to 20.3) |
| Cycle 2 (n=602,195) | 4.8 (3.2 to 6.8) | 9.7 (6.0 to 14.8) |
| Cycle 3 (n=577,196) | 5.2 (3.5 to 7.3) | 11.7 (7.6 to 17.1) |
| Cycle 4 (n=586,194) | 4.1 (2.6 to 6.0) | 7.7 (4.4 to 12.4) |
| Cycle 5 (n=590,187) | 5.4 (3.7 to 7.6) | 6.4 (3.4 to 10.9) |
| Cycle 6 (n=588,185) | 5.8 (4.0 to 8.0) | 9.7 (5.9 to 14.9) |
| Cycle 7 (n=581,186) | 3.4 (2.1 to 5.3) | 7.5 (4.2 to 12.3) |
| Cycle 8 (n=583,188) | 5.0 (3.4 to 7.1) | 6.9 (3.7 to 11.5) |
| Cycle 9 (n=575,187) | 4.3 (2.8 to 6.4) | 8.6 (5.0 to 13.5) |
| Cycle 10 (n=571,183) | 3.7 (2.3 to 5.6) | 6.6 (3.4 to 11.2) |
| Cycle 11 (n=576,177) | 3.0 (1.7 to 4.7) | 7.3 (4.0 to 12.2) |
| Cycle 12 (n=568,176) | 4.0 (2.6 to 6.0) | 10.2 (6.2 to 15.7) |
| Cycle 13 (n=543,173) | 5.9 (4.1 to 8.2) | 10.4 (6.3 to 15.9) |
Collected over Up to 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ENG-EE (NuvaRing) | — | 2/714 (0.3%) | 0/714 (0%) |
| DRSP-EE | — | 4/232 (1.7%) | 0/232 (0%) |
| Event | ENG-EE (NuvaRing) | DRSP-EE |
|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/714 | 2/232 |
| Invasive ductal breast carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/714 | 1/232 |
| Deep vein thrombosisVascular disorders | 0/714 | 1/232 |
| SinusitisInfections and infestations | 1/714 | 0/232 |
| Intraductal proliferative breast lesionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/714 | 0/232 |
All Subjects Treated (AST) group, which consisted of all randomized participants who used at least one ring/pill.
| Age, Continuous(Years) | ENG-EE (NuvaRing) | DRSP-EE | Total |
|---|---|---|---|
| Mean | 31.8 ± 4.0 | 31.2 ± 3.9 | 31.7 ± 4.0 |
| Sex: Female, Male(Participants) | ENG-EE (NuvaRing) | DRSP-EE | Total |
|---|---|---|---|
| Female | 714 | 232 | 946 |
| Male | 0 | 0 | 0 |
No study locations are listed for this record.
Plan to share: No
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Studies of the drug tested here: NuvaRing