Efficacy and Safety Study of the Combined Oral Contraceptive NOMACE2 Compared to a COC Containing DRSP/EE (292002)(P05722)
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ClinicalTrials.gov Identifier: NCT00413062 
Recruitment Status
:
Completed
First Posted
: December 19, 2006
Results First Posted
: August 29, 2011
Last Update Posted
: August 27, 2015

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Study Type:  Interventional 

Study Design:  Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention 
Condition: 
Contraception 
Interventions: 
Drug: NOMACE2 Drug: DRSPEE 
Participant Flow
Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations 

This study recruited participants from North America and South America 
PreAssignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment 

In total, 2281 participants were randomized (NOMACE2 n=1710; DRSPEE n=571) but 2220 participants were treated (NOMACE2 n=1666; DRSPEE n=554). 
Reporting Groups
Description  

NOMACE2  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 124, active tablets; Days 2528, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
DRSPEE  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 121, active tablets; Days 2228, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
Participant Flow: Overall Study
NOMACE2  DRSPEE  

STARTED  1666  554 
COMPLETED  988  344 
NOT COMPLETED  678  210 
Adverse event/serious adverse event  289  56 
Pretreatment (serious) adverse event  1  0 
Withdrawal of informed consent  111  36 
Pregnancy  15  5 
Pregnancy wish  17  6 
Lost to Followup  175  73 
Other reason  70  34 
Baseline Characteristics
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

No text entered. 
Reporting Groups
Description  

NOMACE2  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 124, active tablets; Days 2528, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
DRSPEE  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 121, active tablets; Days 2228, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
Total  Total of all reporting groups 
Baseline Measures
NOMACE2  DRSPEE  Total  

Overall Participants Analyzed [Units: Participants] 
1666  554  2220  
Age [Units: Years] Mean (Standard Deviation) 
27.6 (7.2)  27.8 (7.0)  27.7 (7.1)  
Gender [Units: Participants] 

Female  1666  554  2220  
Male  0  0  0  
Outcome Measures
1. Primary:  Number of Intreatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) [ Time Frame: 1 year (13 cycles) ] 
Measure Type  Primary 

Measure Title  Number of Intreatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) 
Measure Description  Intreatment 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 intreatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant. 
Time Frame  1 year (13 cycles) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

The "restricted ITT" set included all participants treated except for 27 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 sexual intercourse, based on ediary data). 
Reporting Groups
Description  

NOMACE2  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 124, active tablets; Days 2528, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
DRSPEE  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 121, active tablets; Days 2228, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
Measured Values
NOMACE2  DRSPEE  

Participants Analyzed [Units: Participants] 
1370  444 
Units Analyzed (Woman years (rounded to nearest integer)) [Units: Woman years (rounded to nearest integer)] 
684  233 
Number of Intreatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) [Units: Pregnancies per 100 woman years] Number (95% Confidence Interval) 

Overall group 
1.754 (0.9061 to 3.0632) 
3.005 (1.2082 to 6.1917) 
=<35 years old (n=1158; n=378) 
1.963 (0.9798 to 3.5119) 
3.092 (1.1347 to 6.7299) 
>35 years old (n=212; n=66) 
0.807 (0.0204 to 4.4977) 
2.572 (0.0651 to 14.33) 
No statistical analysis provided for Number of Intreatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
2. Primary:  Number of Intreatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) [ Time Frame: 1 year (13 cycles) ] 
Measure Type  Primary 

Measure Title  Number of Intreatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) 
Measure Description  Intreatment 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 intreatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant. 
Time Frame  1 year (13 cycles) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

The "restricted ITT" set included all participants treated except for 27 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 sexual intercourse, based on ediary data). 
Reporting Groups
Description  

NOMACE2  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 124, active tablets; Days 2528, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
DRSPEE  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 121, active tablets; Days 2228, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
Measured Values
NOMACE2  DRSPEE  

Participants Analyzed [Units: Participants] 
1370  444 
Units Analyzed (Woman years (rounded to nearest integer)) [Units: Woman years (rounded to nearest integer)] 
684  233 
Number of Intreatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) [Units: Pregnancies per 100 woman years] Number (95% Confidence Interval) 

Overall group 
2.192 (1.2268 to 3.6154) 
4.293 (2.0587 to 7.8951) 
=<35 years old (n=1158; n=378) 
2.498 (1.3657 to 4.1913) 
4.638 (2.1208 to 8.8042) 
>35 years old (n=212; n=66) 
0.807 (0.0204 to 4.4977) 
2.572 (0.0651 to 14.33) 
No statistical analysis provided for Number of Intreatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
3. Secondary:  Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting [ Time Frame: Every 28day cycle for 13 cycles (one year total) ] 
Measure Type  Secondary 

Measure Title  Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting 
Measure Description  Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using ediaries. 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 nonbleeding period" that was neither an early nor a continued withdrawal bleeding. Expected nonbleeding period: DRSPEE group: 21day period starting on Day 1 of the cycle; NOMACE2: 21day period starting on Day 4 of the cycle. 
Time Frame  Every 28day cycle for 13 cycles (one year total) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

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 nonevaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles. 
Reporting Groups
Description  

NOMACE2  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 124, active tablets; Days 2528, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
DRSPEE  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 121, active tablets; Days 2228, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
Measured Values
NOMACE2  DRSPEE  

Participants Analyzed [Units: Participants] 
1312  436 
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting [Units: Participants] 

Cycle 1 (n=1202 NOMACE2; n=398 DRSPEE)  370  84 
Cycle 2 (n=950 NOMACE2; n=308 DRSPEE)  243  55 
Cycle 3 (n=812 NOMACE2; n=256 DRSPEE)  196  40 
Cycle 4 (n=739 NOMACE2; n=236 DRSPEE)  152  34 
Cycle 5 (n=671 NOMACE2; n=229 DRSPEE)  139  29 
Cycle 6 (n=628 NOMACE2; n=207 DRSPEE)  125  18 
Cycle 7 (n=565 NOMACE2; n=196 DRSPEE)  104  25 
Cycle 8 (n=543 NOMACE2; n=189 DRSPEE)  97  23 
Cycle 9 (n=507 NOMACE2; n=173 DRSPEE)  85  30 
Cycle 10 (n=491 NOMACE2; n=170 DRSPEE)  93  29 
Cycle 11 (n=456 NOMACE2; n=160 DRSPEE)  83  27 
Cycle 12 (n=428 NOMACE2; n=152 DRSPEE)  70  15 
Cycle 13 (n=383 NOMACE2; n=133 DRSPEE)  62  20 
No statistical analysis provided for Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
4. Secondary:  Number of Participants With an Occurrence of Absence of Withdrawal Bleeding [ Time Frame: Every 28day cycle for 13 cycles (one year total) ] 
Measure Type  Secondary 

Measure Title  Number of Participants With an Occurrence of Absence of Withdrawal Bleeding 
Measure Description  Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using ediaries. 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: DRSPEE group: 7day period starting on Day 22 of the cycle; NOMACE2: 7day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle. 
Time Frame  Every 28day cycle for 13 cycles (one year total) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

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 nonevaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles. 
Reporting Groups
Description  

NOMACE2  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 124, active tablets; Days 2528, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
DRSPEE  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 121, active tablets; Days 2228, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
Measured Values
NOMACE2  DRSPEE  

Participants Analyzed [Units: Participants] 
1312  436 
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding [Units: Participants] 

Cycle 1 (n=1202 NOMACE2; n=398 DRSPEE)  216  23 
Cycle 2 (n=950 NOMACE2; n=308 DRSPEE)  167  15 
Cycle 3 (n=812 NOMACE2; n=256 DRSPEE)  178  15 
Cycle 4 (n=739 NOMACE2; n=236 DRSPEE)  184  16 
Cycle 5 (n=671 NOMACE2; n=229 DRSPEE)  169  13 
Cycle 6 (n=628 NOMACE2; n=207 DRSPEE)  166  9 
Cycle 7 (n=565 NOMACE2; n=196 DRSPEE)  139  13 
Cycle 8 (n=543 NOMACE2; n=189 DRSPEE)  152  16 
Cycle 9 (n=507 NOMACE2; n=173 DRSPEE)  151  8 
Cycle 10 (n=491 NOMACE2; n=170 DRSPEE)  147  8 
Cycle 11 (n=456 NOMACE2; n=160 DRSPEE)  156  6 
Cycle 12 (n=428 NOMACE2; n=152 DRSPEE)  141  10 
Cycle 13 (n=383 NOMACE2; n=133 DRSPEE)  187  7 
No statistical analysis provided for Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
5. Secondary:  Number of Participants With an Occurrence of Breakthrough Bleeding [ Time Frame: Every 28day cycle for 13 cycles (one year total) ] 
Measure Type  Secondary 

Measure Title  Number of Participants With an Occurrence of Breakthrough Bleeding 
Measure Description 
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using ediaries. 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 nonbleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected nonbleeding period: DRSPEE group: 21day period starting on Day 1 of the cycle; NOMACE2: 21day period starting on Day 4 of the cycle. 
Time Frame  Every 28day cycle for 13 cycles (one year total) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

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 nonevaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles. 
Reporting Groups
Description  

NOMACE2  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 124, active tablets; Days 2528, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
DRSPEE  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 121, active tablets; Days 2228, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
Measured Values
NOMACE2  DRSPEE  

Participants Analyzed [Units: Participants] 
1312  436 
Number of Participants With an Occurrence of Breakthrough Bleeding [Units: Participants] 

Cycle 1 (n=1202 NOMACE2; n=398 DRSPEE)  100  19 
Cycle 2 (n=950 NOMACE2; n=308 DRSPEE)  47  5 
Cycle 3 (n=812 NOMACE2; n=256 DRSPEE)  43  5 
Cycle 4 (n=739 NOMACE2; n=236 DRSPEE)  39  7 
Cycle 5 (n=671 NOMACE2; n=229 DRSPEE)  30  4 
Cycle 6 (n=628 NOMACE2; n=207 DRSPEE)  29  4 
Cycle 7 (n=565 NOMACE2; n=196 DRSPEE)  31  5 
Cycle 8 (n=543 NOMACE2; n=189 DRSPEE)  25  5 
Cycle 9 (n=507 NOMACE2; n=173 DRSPEE)  24  7 
Cycle 10 (n=491 NOMACE2; n=170 DRSPEE)  27  9 
Cycle 11 (n=456 NOMACE2; n=160 DRSPEE)  19  5 
Cycle 12 (n=428 NOMACE2; n=152 DRSPEE)  16  3 
Cycle 13 (n=383 NOMACE2; n=133 DRSPEE)  16  2 
No statistical analysis provided for Number of Participants With an Occurrence of Breakthrough Bleeding
6. Secondary:  Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) [ Time Frame: Every 28day cycle for 13 cycles (one year total) ] 
Measure Type  Secondary 

Measure Title  Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) 
Measure Description 
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using ediaries. 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 nonbleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected nonbleeding period: DRSPEE group: 21day period starting on Day 1 of the cycle; NOMACE2: 21day period starting on Day 4 of the cycle. 
Time Frame  Every 28day cycle for 13 cycles (one year total) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

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 nonevaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles. 
Reporting Groups
Description  

NOMACE2  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 124, active tablets; Days 2528, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
DRSPEE  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 121, active tablets; Days 2228, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
Measured Values
NOMACE2  DRSPEE  

Participants Analyzed [Units: Participants] 
1312  436 
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) [Units: Participants] 

Cycle 1 (n=1202 NOMACE2; n=398 DRSPEE)  306  72 
Cycle 2 (n=950 NOMACE2; n=308 DRSPEE)  211  50 
Cycle 3 (n=812 NOMACE2; n=256 DRSPEE)  168  36 
Cycle 4 (n=739 NOMACE2; n=236 DRSPEE)  126  30 
Cycle 5 (n=671 NOMACE2; n=229 DRSPEE)  114  25 
Cycle 6 (n=628 NOMACE2; n=207 DRSPEE)  102  16 
Cycle 7 (n=565 NOMACE2; n=196 DRSPEE)  85  20 
Cycle 8 (n=543 NOMACE2; n=189 DRSPEE)  78  18 
Cycle 9 (n=507 NOMACE2; n=173 DRSPEE)  64  23 
Cycle 10 (n=491 NOMACE2; n=170 DRSPEE)  71  21 
Cycle 11 (n=456 NOMACE2; n=160 DRSPEE)  67  22 
Cycle 12 (n=428 NOMACE2; n=152 DRSPEE)  59  12 
Cycle 13 (n=383 NOMACE2; n=133 DRSPEE)  46  18 
No statistical analysis provided for Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
7. Secondary:  Number of Participants With an Occurrence of Early Withdrawal Bleeding [ Time Frame: Every 28day cycle for 13 cycles (one year total) ] 
Measure Type  Secondary 

Measure Title  Number of Participants With an Occurrence of Early Withdrawal Bleeding 
Measure Description 
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using ediaries. 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: DRSPEE group: 7day period starting on Day 22 of the cycle; NOMACE2: 7day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle. 
Time Frame  Every 28day cycle for 13 cycles (one year total) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

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 nonevaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles. 
Reporting Groups
Description  

NOMACE2  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 124, active tablets; Days 2528, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
DRSPEE  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 121, active tablets; Days 2228, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
Measured Values
NOMACE2  DRSPEE  

Participants Analyzed [Units: Participants] 
1312  436 
Number of Participants With an Occurrence of Early Withdrawal Bleeding [Units: Participants] 

Cycle 1 (n=1202 NOMACE2; n=398 DRSPEE)  175  46 
Cycle 2 (n=950 NOMACE2; n=308 DRSPEE)  68  14 
Cycle 3 (n=812 NOMACE2; n=256 DRSPEE)  66  24 
Cycle 4 (n=739 NOMACE2; n=236 DRSPEE)  48  9 
Cycle 5 (n=671 NOMACE2; n=229 DRSPEE)  36  11 
Cycle 6 (n=628 NOMACE2; n=207 DRSPEE)  28  11 
Cycle 7 (n=565 NOMACE2; n=196 DRSPEE)  22  11 
Cycle 8 (n=543 NOMACE2; n=189 DRSPEE)  29  13 
Cycle 9 (n=507 NOMACE2; n=173 DRSPEE)  17  9 
Cycle 10 (n=491 NOMACE2; n=170 DRSPEE)  27  13 
Cycle 11 (n=456 NOMACE2; n=160 DRSPEE)  17  7 
Cycle 12 (n=428 NOMACE2; n=152 DRSPEE)  10  6 
Cycle 13 (n=383 NOMACE2; n=133 DRSPEE)  9  6 
No statistical analysis provided for Number of Participants With an Occurrence of Early Withdrawal Bleeding
8. Secondary:  Number of Participants With an Occurrence of Continued Withdrawal Bleeding [ Time Frame: Every 28day cycle for 12 cycles ] 
Measure Type  Secondary 

Measure Title  Number of Participants With an Occurrence of Continued Withdrawal Bleeding 
Measure Description 
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using ediaries. 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 nonbleeding period" of the next cycle. Expected nonbleeding period: DRSPEE group: 21day period starting on Day 1 of the cycle; NOMACE2: 21day period starting on Day 4 of the cycle. 
Time Frame  Every 28day cycle for 12 cycles 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

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 nonevaluable in case of insufficient bleeding data or improper cycle length. 
Reporting Groups
Description  

NOMACE2 
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 124, active tablets; Days 2528, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined). 
DRSPEE 
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 121, active tablets; Days 2228, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined). 
Measured Values
NOMACE2  DRSPEE  

Participants Analyzed [Units: Participants] 
1312  436 
Number of Participants With an Occurrence of Continued Withdrawal Bleeding [Units: Participants] 

Cycle 1 (n=1179 NOMACE2; n=393 DRSPEE)  367  216 
Cycle 2 (n=939 NOMACE2; n=304 DRSPEE)  309  174 
Cycle 3 (n=794 NOMACE2; n=254 DRSPEE)  225  149 
Cycle 4 (n=730 NOMACE2; n=235 DRSPEE)  192  145 
Cycle 5 (n=659 NOMACE2; n=227 DRSPEE)  171  135 
Cycle 6 (n=617 NOMACE2; n=207 DRSPEE)  149  122 
Cycle 7 (n=555 NOMACE2; n=194 DRSPEE)  142  111 
Cycle 8 (n=540 NOMACE2; n=188 DRSPEE)  128  107 
Cycle 9 (n=503 NOMACE2; n=171 DRSPEE)  116  106 
Cycle 10 (n=486 NOMACE2; n=169 DRSPEE)  121  95 
Cycle 11 (n=455 NOMACE2; n=159 DRSPEE)  90  94 
Cycle 12 (n=421 NOMACE2; n=149 DRSPEE)  95  78 
No statistical analysis provided for Number of Participants With an Occurrence of Continued Withdrawal Bleeding
9. Secondary:  Average Number of Breakthrough Bleeding/Spotting Days [ Time Frame: Every 28day cycle for 13 cycles (one year total) ] 
Measure Type  Secondary 

Measure Title  Average Number of Breakthrough Bleeding/Spotting Days 
Measure Description  Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using ediaries. 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 nonbleeding period" that was neither an early nor a continued withdrawal bleeding. Expected nonbleeding period: DRSPEE group: 21day period starting on Day 1 of the cycle; NOMACE2: 21day period starting on Day 4 of the cycle. 
Time Frame  Every 28day cycle for 13 cycles (one year total) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

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 nonevaluable in case of insufficient bleeding data or improper cycle length. n= number of participants who had breakthrough bleeding/spotting for the respective cycle. 
Reporting Groups
Description  

NOMACE2  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 124, active tablets; Days 2528, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
DRSPEE  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 121, active tablets; Days 2228, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
Measured Values
NOMACE2  DRSPEE  

Participants Analyzed [Units: Participants] 
1312  436 
Average Number of Breakthrough Bleeding/Spotting Days [Units: Days] Mean (Standard Deviation) 

Cycle 1 (n=370 NOMACE2; n=84 DRSPEE)  4.5 (3.6)  4.0 (2.9) 
Cycle 2 (n=243 NOMACE2; n=55 DRSPEE)  3.5 (2.7)  2.7 (2.3) 
Cycle 3 (n=196 NOMACE2; n=40 DRSPEE)  3.2 (2.5)  2.6 (2.0) 
Cycle 4 (n=152 NOMACE2; n=34 DRSPEE)  3.5 (2.7)  3.2 (2.5) 
Cycle 5 (n=139 NOMACE2; n=29 DRSPEE)  3.6 (3.0)  2.6 (2.1) 
Cycle 6 (n=125 NOMACE2; n=18 DRSPEE)  3.2 (2.7)  3.0 (1.7) 
Cycle 7 (n=104 NOMACE2; n=25 DRSPEE)  3.9 (2.9)  2.9 (2.0) 
Cycle 8 (n=97 NOMACE2; n=23 DRSPEE)  3.4 (2.4)  2.6 (2.4) 
Cycle 9 (n=85 NOMACE2; n=30 DRSPEE)  3.5 (3.2)  3.2 (2.2) 
Cycle 10 (n=93 NOMACE2; n=29 DRSPEE)  2.6 (2.1)  3.2 (2.1) 
Cycle 11 (n=83 NOMACE2; n=27 DRSPEE)  3.6 (2.5)  2.9 (2.0) 
Cycle 12 (n=70 NOMACE2; n=15 DRSPEE)  2.9 (2.4)  3.1 (2.9) 
Cycle 13 (n=62 NOMACE2; n=20 DRSPEE)  2.8 (2.2)  3.0 (1.9) 
No statistical analysis provided for Average Number of Breakthrough Bleeding/Spotting Days
10. Secondary:  Average Number of Withdrawal Bleeding/Spotting Days [ Time Frame: Every 28day cycle for 13 cycles (one year total) ] 
Measure Type  Secondary 

Measure Title  Average Number of Withdrawal Bleeding/Spotting Days 
Measure Description  Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using ediaries. 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: DRSPEE group: 7day period starting on Day 22 of the cycle; NOMACE2: 7day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle. 
Time Frame  Every 28day cycle for 13 cycles (one year total) 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

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 nonevaluable in case of insufficient bleeding data or improper cycle length. n= number of participants who had withdrawal bleeding/spotting for the respective cycle. 
Reporting Groups
Description  

NOMACE2  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 124, active tablets; Days 2528, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
DRSPEE  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 121, active tablets; Days 2228, placebo tablets) for 13 consecutive 28day menstrual cycles (1 year). 
Measured Values
NOMACE2  DRSPEE  

Participants Analyzed [Units: Participants] 
1312  436 
Average Number of Withdrawal Bleeding/Spotting Days [Units: Days] Mean (Standard Deviation) 

Cycle 1 (n=986 NOMACE2; n=375 DRSPEE)  5.7 (5.0)  6.0 (3.5) 
Cycle 2 (n=783 NOMACE2; n=293 DRSPEE)  5.0 (4.6)  6.2 (17.1) 
Cycle 3 (n=634 NOMACE2; n=241 DRSPEE)  4.8 (4.4)  6.6 (18.9) 
Cycle 4 (n=555 NOMACE2; n=220 DRSPEE)  4.5 (2.9)  6.5 (19.8) 
Cycle 5 (n=502 NOMACE2; n=216 DRSPEE)  4.5 (3.5)  6.6 (19.9) 
Cycle 6 (n=462 NOMACE2; n=198 DRSPEE)  4.1 (2.5)  6.6 (20.8) 
Cycle 7 (n=426 NOMACE2; n=183 DRSPEE)  4.2 (3.4)  6.5 (21.6) 
Cycle 8 (n=391 NOMACE2; n=173 DRSPEE)  4.1 (2.4)  6.8 (22.3) 
Cycle 9 (n=356 NOMACE2; n=165 DRSPEE)  3.9 (2.2)  6.9 (22.8) 
Cycle 10 (n=344 NOMACE2; n=162 DRSPEE)  4.2 (2.8)  6.8 (23.0) 
Cycle 11 (n=300 NOMACE2; n=154 DRSPEE)  3.8 (1.9)  6.8 (23.6) 
Cycle 12 (n=287 NOMACE2; n=142 DRSPEE)  3.8 (2.5)  6.9 (24.6) 
Cycle 13 (n=196 NOMACE2; n=126 DRSPEE)  2.8 (2.3)  4.3 (1.6) 
No statistical analysis provided for Average Number of Withdrawal Bleeding/Spotting Days
Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data 

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