Trial Outcomes & Findings for Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724) (NCT NCT00511199)
NCT ID: NCT00511199
Last Updated: 2022-02-09
Results Overview
In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.
COMPLETED
PHASE3
2152 participants
1 year (13 cycles)
2022-02-09
Participant Flow
This study recruited participants from Europe, Asia and Australia.
In total, 2152 subjects were randomized, of which 1613 subjects to NOMAC-E2 and 539 subjects to DRSP-EE. A total of 2126 subjects were randomized and treated, of which 1591 subjects on NOMAC-E2 and 535 subjects on DRSP-EE.
Participant milestones
| Measure |
NOMAC-E2
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Overall Study
STARTED
|
1591
|
535
|
|
Overall Study
COMPLETED
|
1142
|
410
|
|
Overall Study
NOT COMPLETED
|
449
|
125
|
Reasons for withdrawal
| Measure |
NOMAC-E2
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Overall Study
Unacceptable Vaginal Bleeding
|
63
|
4
|
|
Overall Study
Other Adverse Event (AE)/ Serious AE
|
227
|
52
|
|
Overall Study
Withdrawal of Informed Consent
|
19
|
4
|
|
Overall Study
Pregnancy
|
6
|
3
|
|
Overall Study
Pregnancy Wish
|
16
|
8
|
|
Overall Study
Lost to Follow-up
|
40
|
17
|
|
Overall Study
Other Reason
|
78
|
37
|
Baseline Characteristics
Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)
Baseline characteristics by cohort
| Measure |
NOMAC-E2
n=1591 Participants
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
n=535 Participants
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
Total
n=2126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.1 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
27.6 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
28.0 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1591 Participants
n=5 Participants
|
535 Participants
n=7 Participants
|
2126 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: 1 year (13 cycles)Population: Restricted ITT set included all participants treated except for 2 nonpregnant participants whose exposure was excluded due to limited credibility of diary data \& also excluded nonpregnant participants without \>= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o confirmed sexual intercourse, based on e-diary data).
In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.
Outcome measures
| Measure |
NOMAC-E2
n=857 woman years (rounded to nearest integer)
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
n=295 woman years (rounded to nearest integer)
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
Overall group
|
0.467 Pregnancies per 100 woman years
Interval 0.1271 to 1.1948
|
1.017 Pregnancies per 100 woman years
Interval 0.2097 to 2.971
|
|
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
=<35 years old (n= 1193; n=402)
|
0.571 Pregnancies per 100 woman years
Interval 0.1555 to 1.4614
|
1.261 Pregnancies per 100 woman years
Interval 0.2601 to 3.6858
|
|
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
>35 years old (n= 249; n=84)
|
0.000 Pregnancies per 100 woman years
Interval 0.0 to 2.3594
|
0.000 Pregnancies per 100 woman years
Interval 0.0 to 6.4466
|
PRIMARY outcome
Timeframe: 1 year (13 cycles)Population: Restricted ITT set included all participants treated except for 2 nonpregnant participants whose exposure was excluded due to limited credibility of diary data \& also excluded nonpregnant participants without \>= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o confirmed sexual intercourse, based on e-diary data).
In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.
Outcome measures
| Measure |
NOMAC-E2
n=857 woman years (rounded to nearest integer)
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
n=295 woman years (rounded to nearest integer)
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
Overall group
|
0.817 Pregnancies per 100 woman years
Interval 0.3283 to 1.6826
|
1.356 Pregnancies per 100 woman years
Interval 0.3693 to 3.4707
|
|
Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
=<35 years old (n=1193; n=402)
|
0.999 Pregnancies per 100 woman years
Interval 0.4016 to 2.058
|
1.682 Pregnancies per 100 woman years
Interval 0.4582 to 4.3056
|
|
Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
>35 years old (n=249; n=84)
|
0.000 Pregnancies per 100 woman years
Interval 0.0 to 2.3594
|
0.000 Pregnancies per 100 woman years
Interval 0.0 to 6.4466
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 13 cycles (one year total)Population: The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles.
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Outcome measures
| Measure |
NOMAC-E2
n=1524 Participants
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
n=503 Participants
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 7 (n=931 NOMAC-E2; n=320 DRSP-EE)
|
165 participants
|
45 participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 8 (n=874 NOMAC-E2; n=298 DRSP-EE)
|
127 participants
|
47 participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 11 (n=770 NOMAC-E2; n=277 DRSP-EE)
|
125 participants
|
29 participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 1 (n=1466 NOMAC-E2; n=470 DRSP-EE)
|
483 participants
|
130 participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 2 (n=1339 NOMAC-E2; n=440 DRSP-EE)
|
289 participants
|
75 participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 3 (n=1233 NOMAC-E2; n=398 DRSP-EE)
|
297 participants
|
54 participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 4 (n=1135 NOMAC-E2; n=389 DRSP-EE)
|
231 participants
|
59 participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 5 (n=1064 NOMAC-E2; n=368 DRSP-EE)
|
221 participants
|
62 participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 6 (n=982 NOMAC-E2; n=349 DRSP-EE)
|
182 participants
|
53 participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 9 (n=861 NOMAC-E2; n=295 DRSP-EE)
|
129 participants
|
47 participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 10 (n=809 NOMAC-E2; n=271 DRSP-EE)
|
121 participants
|
32 participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 12 (n=743 NOMAC-E2; n=259 DRSP-EE)
|
110 participants
|
30 participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle 13 (n=666 NOMAC-E2; n=241 DRSP-EE)
|
94 participants
|
33 participants
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 13 cycles (one year total)Population: The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles.
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Outcome measures
| Measure |
NOMAC-E2
n=1524 Participants
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
n=503 Participants
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 6 (n=982 NOMAC-E2; n=349 DRSP-EE)
|
249 participants
|
10 participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 10 (n=809 NOMAC-E2; n=271 DRSP-EE)
|
245 participants
|
12 participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 13 (n=666 NOMAC-E2; n=241 DRSP-EE)
|
279 participants
|
14 participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 1 (n=1466 NOMAC-E2; n=470 DRSP-EE)
|
284 participants
|
14 participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 2 (n=1339 NOMAC-E2; n=440 DRSP-EE)
|
237 participants
|
17 participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 3 (n=1233 NOMAC-E2; n=398 DRSP-EE)
|
258 participants
|
18 participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 4 (n=1135 NOMAC-E2; n=389 DRSP-EE)
|
244 participants
|
20 participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 5 (n=1064 NOMAC-E2; n=368 DRSP-EE)
|
245 participants
|
17 participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 7 (n=931 NOMAC-E2; n=320 DRSP-EE)
|
245 participants
|
11 participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 8 (n=874 NOMAC-E2; n=298 DRSP-EE)
|
235 participants
|
9 participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 9 (n=861 NOMAC-E2; n=295 DRSP-EE)
|
245 participants
|
13 participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 11 (n=770 NOMAC-E2; n=277 DRSP-EE)
|
232 participants
|
17 participants
|
|
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle 12 (n=743 NOMAC-E2; n=259 DRSP-EE)
|
227 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 13 cycles (one year total)Population: The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles.
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Outcome measures
| Measure |
NOMAC-E2
n=1524 Participants
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
n=503 Participants
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 1 (n=1466 NOMAC-E2; n=470 DRSP-EE)
|
129 Participants
|
24 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 2 (n=1339 NOMAC-E2; n=440 DRSP-EE)
|
63 Participants
|
20 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 3 (n=1233 NOMAC-E2; n=398 DRSP-EE)
|
61 Participants
|
16 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 4 (n=1135 NOMAC-E2; n=389 DRSP-EE)
|
54 Participants
|
11 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 5 (n=1064 NOMAC-E2; n=368 DRSP-EE)
|
52 Participants
|
12 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 6 (n=982 NOMAC-E2; n=349 DRSP-EE)
|
43 Participants
|
8 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 7 (n=931 NOMAC-E2; n=320 DRSP-EE)
|
41 Participants
|
7 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 8 (n=874 NOMAC-E2; n=298 DRSP-EE)
|
28 Participants
|
5 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 9 (n=861 NOMAC-E2; n=295 DRSP-EE)
|
32 Participants
|
7 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 10 (n=809 NOMAC-E2; n=271 DRSP-EE)
|
23 Participants
|
7 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 11 (n=770 NOMAC-E2; n=277 DRSP-EE)
|
27 Participants
|
7 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 12 (n=743 NOMAC-E2; n=259 DRSP-EE)
|
30 Participants
|
13 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle 13 (n=666 NOMAC-E2; n=241 DRSP-EE)
|
21 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 13 cycles (one year total)Population: The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles.
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Outcome measures
| Measure |
NOMAC-E2
n=1524 Participants
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
n=503 Participants
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 8 (n=874 NOMAC-E2; n=298 DRSP-EE)
|
104 Participants
|
43 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 12 (n=743 NOMAC-E2; n=259 DRSP-EE)
|
87 Participants
|
18 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 1 (n=1466 NOMAC-E2; n=470 DRSP-EE)
|
408 Participants
|
118 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 2 (n=1339 NOMAC-E2; n=440 DRSP-EE)
|
244 Participants
|
58 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 3 (n=1233 NOMAC-E2; n=398 DRSP-EE)
|
257 Participants
|
42 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 4 (n=1135 NOMAC-E2; n=389 DRSP-EE)
|
186 Participants
|
51 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 5 (n=1064 NOMAC-E2; n=368 DRSP-EE)
|
180 Participants
|
52 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 6 (n=982 NOMAC-E2; n=349 DRSP-EE)
|
148 Participants
|
45 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 7 (n=931 NOMAC-E2; n=320 DRSP-EE)
|
135 Participants
|
40 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 9 (n=861 NOMAC-E2; n=295 DRSP-EE)
|
106 Participants
|
40 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 10 (n=809 NOMAC-E2; n=271 DRSP-EE)
|
105 Participants
|
27 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 11 (n=770 NOMAC-E2; n=277 DRSP-EE)
|
100 Participants
|
22 Participants
|
|
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle 13 (n=666 NOMAC-E2; n=241 DRSP-EE)
|
76 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 13 cycles (one year total)Population: The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles.
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Outcome measures
| Measure |
NOMAC-E2
n=1524 Participants
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
n=503 Participants
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 3 (n=1233 NOMAC-E2; n=398 DRSP-EE)
|
80 Participants
|
22 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 1 (n=1466 NOMAC-E2; n=470 DRSP-EE)
|
142 Participants
|
52 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 2 (n=1339 NOMAC-E2; n=440 DRSP-EE)
|
93 Participants
|
29 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 4 (n=1135 NOMAC-E2; n=389 DRSP-EE)
|
69 Participants
|
20 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 5 (n=1064 NOMAC-E2; n=368 DRSP-EE)
|
55 Participants
|
22 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 6 (n=982 NOMAC-E2; n=349 DRSP-EE)
|
34 Participants
|
16 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 7 (n=931 NOMAC-E2; n=320 DRSP-EE)
|
36 Participants
|
18 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 8 (n=874 NOMAC-E2; n=298 DRSP-EE)
|
31 Participants
|
12 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 9 (n=861 NOMAC-E2; n=295 DRSP-EE)
|
33 Participants
|
11 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 10 (n=809 NOMAC-E2; n=271 DRSP-EE)
|
19 Participants
|
9 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 11 (n=770 NOMAC-E2; n=277 DRSP-EE)
|
27 Participants
|
9 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 12 (n=743 NOMAC-E2; n=259 DRSP-EE)
|
18 Participants
|
9 Participants
|
|
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle 13 (n=666 NOMAC-E2; n=241 DRSP-EE)
|
17 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 12 cyclesPopulation: The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the "expected non-bleeding period" of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Outcome measures
| Measure |
NOMAC-E2
n=1524 Participants
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
n=503 Participants
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 5 (n=1051 NOMAC-E2; n=365 DRSP-EE)
|
280 Participants
|
203 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 9 (n=854 NOMAC-E2; n=291 DRSP-EE)
|
228 Participants
|
176 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 1 (n=1455 NOMAC-E2; n=466 DRSP-EE)
|
412 Participants
|
283 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 2 (n=1320 NOMAC-E2; n=437 DRSP-EE)
|
406 Participants
|
274 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 3 (n=1201 NOMAC-E2; n=397 DRSP-EE)
|
364 Participants
|
243 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 4 (n=1120 NOMAC-E2; n=387 DRSP-EE)
|
321 Participants
|
222 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 6 (n=965 NOMAC-E2; n=348 DRSP-EE)
|
285 Participants
|
190 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 7 (n=920 NOMAC-E2; n=318 DRSP-EE)
|
247 Participants
|
190 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 8 (n=868 NOMAC-E2; n=296 DRSP-EE)
|
224 Participants
|
170 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 10 (n=806 NOMAC-E2; n=269 DRSP-EE)
|
191 Participants
|
158 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 11 (n=766 NOMAC-E2; n=276 DRSP-EE)
|
195 Participants
|
162 Participants
|
|
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle 12 (n=725 NOMAC-E2; n=257 DRSP-EE)
|
184 Participants
|
153 Participants
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 13 cycles (one year total)Population: ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants who had breakthrough bleeding/spotting for the respective cycle.
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Outcome measures
| Measure |
NOMAC-E2
n=1524 Participants
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
n=503 Participants
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 1 (n=483 NOMAC-E2; n=130 DRSP-EE)
|
4.6 days
Standard Deviation 3.6
|
4.2 days
Standard Deviation 3.0
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 2 (n=289 NOMAC-E2; n=75 DRSP-EE)
|
3.5 days
Standard Deviation 2.8
|
3.2 days
Standard Deviation 2.5
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 3 (n=297 NOMAC-E2; n=54 DRSP-EE)
|
3.4 days
Standard Deviation 2.6
|
3.6 days
Standard Deviation 2.8
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 4 (n=231 NOMAC-E2; n=59 DRSP-EE)
|
3.1 days
Standard Deviation 2.5
|
2.9 days
Standard Deviation 2.5
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 5 (n=221 NOMAC-E2; n=62 DRSP-EE)
|
3.2 days
Standard Deviation 2.5
|
2.9 days
Standard Deviation 2.8
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 6 (n=182 NOMAC-E2; n=53 DRSP-EE)
|
3.3 days
Standard Deviation 2.5
|
2.4 days
Standard Deviation 2.0
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 7 (n=165 NOMAC-E2; n=45 DRSP-EE)
|
3.2 days
Standard Deviation 2.5
|
3.0 days
Standard Deviation 2.8
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 8 (n=127 NOMAC-E2; n=47 DRSP-EE)
|
3.1 days
Standard Deviation 2.4
|
2.7 days
Standard Deviation 1.9
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 9 (n=129 NOMAC-E2; n=47 DRSP-EE)
|
3.4 days
Standard Deviation 2.6
|
2.6 days
Standard Deviation 2.2
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 10 (n=121 NOMAC-E2; n=32 DRSP-EE)
|
3.1 days
Standard Deviation 2.5
|
3.1 days
Standard Deviation 2.6
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 11 (n=125 NOMAC-E2; n=29 DRSP-EE)
|
2.8 days
Standard Deviation 2.4
|
2.6 days
Standard Deviation 2.5
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 12 (n=110 NOMAC-E2; n=30 DRSP-EE)
|
3.1 days
Standard Deviation 2.2
|
2.6 days
Standard Deviation 2.3
|
|
Average Number of Breakthrough Bleeding/Spotting Days
Cycle 13 (n=94 NOMAC-E2; n=33 DRSP-EE)
|
2.7 days
Standard Deviation 2.0
|
3.2 days
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Every 28-day cycle for 13 cycles (one year total)Population: ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants who had withdrawal bleeding/spotting for the respective cycle.
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Outcome measures
| Measure |
NOMAC-E2
n=1524 Participants
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
n=503 Participants
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Average Number of Withdrawal Bleeding/Spotting Days
Cycle 4 (n=891 NOMAC-E2; n=369 DRSP-EE)
|
6.0 days
Standard Deviation 19.9
|
5.4 days
Standard Deviation 3.5
|
|
Average Number of Withdrawal Bleeding/Spotting Days
Cycle 9 (n=616 NOMAC-E2; n=282 DRSP-EE)
|
5.7 days
Standard Deviation 21.9
|
5.7 days
Standard Deviation 8.5
|
|
Average Number of Withdrawal Bleeding/Spotting Days
Cycle 8 (n=639 NOMAC-E2; n=289 DRSP-EE)
|
5.6 days
Standard Deviation 22.3
|
5.7 days
Standard Deviation 8.5
|
|
Average Number of Withdrawal Bleeding/Spotting Days
Cycle 10 (n=564 NOMAC-E2; n=259 DRSP-EE)
|
5.7 days
Standard Deviation 23.5
|
5.5 days
Standard Deviation 8.2
|
|
Average Number of Withdrawal Bleeding/Spotting Days
Cycle 11 (n=538 NOMAC-E2; n=260 DRSP-EE)
|
6.0 days
Standard Deviation 24.1
|
5.6 days
Standard Deviation 8.3
|
|
Average Number of Withdrawal Bleeding/Spotting Days
Cycle 12 (n=516 NOMAC-E2; n=247 DRSP-EE)
|
5.6 days
Standard Deviation 21.3
|
5.7 days
Standard Deviation 8.9
|
|
Average Number of Withdrawal Bleeding/Spotting Days
Cycle 13 (n=387 NOMAC-E2; n=227 DRSP-EE)
|
4.9 days
Standard Deviation 23.9
|
4.2 days
Standard Deviation 3.8
|
|
Average Number of Withdrawal Bleeding/Spotting Days
Cycle 1 (n=1182 NOMAC-E2; n=456 DRSP-EE)
|
5.7 days
Standard Deviation 11.2
|
6.0 days
Standard Deviation 3.3
|
|
Average Number of Withdrawal Bleeding/Spotting Days
Cycle 2 (n=1102 NOMAC-E2; n=423 DRSP-EE)
|
5.6 days
Standard Deviation 15.1
|
5.5 days
Standard Deviation 2.2
|
|
Average Number of Withdrawal Bleeding/Spotting Days
Cycle 3 (n=975 NOMAC-E2; n=380 DRSP-EE)
|
5.9 days
Standard Deviation 19.0
|
5.4 days
Standard Deviation 2.4
|
|
Average Number of Withdrawal Bleeding/Spotting Days
Cycle 5 (n=819 NOMAC-E2; n=351 DRSP-EE)
|
6.0 days
Standard Deviation 20.8
|
5.3 days
Standard Deviation 3.4
|
|
Average Number of Withdrawal Bleeding/Spotting Days
Cycle 6 (n=733 NOMAC-E2; n=339 DRSP-EE)
|
5.8 days
Standard Deviation 21.8
|
5.2 days
Standard Deviation 2.8
|
|
Average Number of Withdrawal Bleeding/Spotting Days
Cycle 7 (n=686 NOMAC-E2; n=309 DRSP-EE)
|
5.8 days
Standard Deviation 22.4
|
5.2 days
Standard Deviation 2.5
|
Adverse Events
NOMAC-E2
DRSP-EE
Serious adverse events
| Measure |
NOMAC-E2
n=1591 participants at risk
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
n=535 participants at risk
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Ear and labyrinth disorders
Vestibular neuronitis
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Gastrointestinal disorders
Abdominal pain
|
0.06%
1/1591 • Number of events 1
|
0.19%
1/535 • Number of events 1
|
|
Gastrointestinal disorders
Anal fissure
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Gastrointestinal disorders
Constipation
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Gastrointestinal disorders
Enteritis
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1591
|
0.19%
1/535 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/1591
|
0.19%
1/535 • Number of events 1
|
|
General disorders
Pyrexia
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.13%
2/1591 • Number of events 2
|
0.00%
0/535
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Infections and infestations
Appendicitis
|
0.06%
1/1591 • Number of events 1
|
0.19%
1/535 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1591
|
0.19%
1/535 • Number of events 1
|
|
Infections and infestations
Cryptosporidiosis infection
|
0.00%
0/1591
|
0.19%
1/535 • Number of events 1
|
|
Infections and infestations
Encephalitis viral
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/1591
|
0.19%
1/535 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.19%
3/1591 • Number of events 3
|
0.00%
0/535
|
|
Infections and infestations
Giardiasis
|
0.00%
0/1591
|
0.19%
1/535 • Number of events 1
|
|
Infections and infestations
Peritonsillar abscess
|
0.13%
2/1591 • Number of events 2
|
0.00%
0/535
|
|
Infections and infestations
Pilonidal cyst
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Infections and infestations
Pyelonephritis
|
0.06%
1/1591 • Number of events 1
|
0.19%
1/535 • Number of events 1
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/1591
|
0.19%
1/535 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/1591
|
0.19%
1/535 • Number of events 1
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/1591
|
0.19%
1/535 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.19%
3/1591 • Number of events 3
|
0.19%
1/535 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/1591
|
0.19%
1/535 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/1591
|
0.19%
1/535 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Nervous system disorders
Headache
|
0.00%
0/1591
|
0.19%
1/535 • Number of events 1
|
|
Nervous system disorders
Multiple Sclerosis
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Psychiatric disorders
Depression
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Reproductive system and breast disorders
Haematosalpinx
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.06%
1/1591 • Number of events 1
|
0.00%
0/535
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.13%
2/1591 • Number of events 2
|
0.00%
0/535
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1591
|
0.19%
1/535 • Number of events 1
|
Other adverse events
| Measure |
NOMAC-E2
n=1591 participants at risk
Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual
period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
DRSP-EE
n=535 participants at risk
Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
|
|---|---|---|
|
Infections and infestations
Influenza
|
3.5%
55/1591 • Number of events 61
|
5.6%
30/535 • Number of events 36
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
144/1591 • Number of events 190
|
9.9%
53/535 • Number of events 66
|
|
Infections and infestations
Vaginal candidiasis
|
8.0%
127/1591 • Number of events 143
|
8.4%
45/535 • Number of events 53
|
|
Investigations
Weight increased
|
9.9%
158/1591 • Number of events 162
|
6.9%
37/535 • Number of events 38
|
|
Nervous system disorders
Headache
|
13.6%
217/1591 • Number of events 405
|
13.5%
72/535 • Number of events 123
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
7.0%
111/1591 • Number of events 112
|
7.3%
39/535 • Number of events 40
|
|
Reproductive system and breast disorders
Withdrawal bleeding irregular
|
11.8%
188/1591 • Number of events 424
|
0.37%
2/535 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Acne
|
17.6%
280/1591 • Number of events 335
|
8.8%
47/535 • Number of events 53
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by the SPONSOR. Any such scientific paper, presentation, or other communication concerning the clinical trial will first be submitted to the SPONSOR, at least six weeks ahead of estimated publication or presentation, for consent, which shall not be withheld unreasonably.
- Publication restrictions are in place
Restriction type: OTHER