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LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

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ClinicalTrials.gov Identifier: NCT01254292
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : April 7, 2014
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Contraception
Interventions Drug: Levonorgestrel IUD (LCS, BAY86-5028)
Drug: Yasmin (EE30/DRSP, BAY86-5131)
Enrollment 567
Recruitment Details The study was conducted in 42 centers across 4 countries in Austria, Belgium, Germany and United States.
Pre-assignment Details 644 subjects were screened, of which 77 were screen failures and 567 were randomized, 282 subjects to LCS12 and 285 subjects to Yasmin. 279 subjects randomized to LCS12 while 281 subjects randomized to Yasmin received treatment and started comparative phase up to 18 months. 200 subjects randomized to LCS12 entered extension phase up to 36 months.
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Period Title: Comparative Phase
Started 282 285
Participants Received Treatment 279 [1] 281 [1]
Completed 227 204
Not Completed 55 81
Reason Not Completed
Adverse Event             25             25
Lost to Follow-up             3             21
Pregnancy             2             6
Withdrawal by Subject             20             21
Protocol Violation             1             2
Wish for pregnancy             4             6
[1]
safety population
Period Title: LCS12 Extension Phase
Started 200 [1] 0 [2]
Completed 163 0
Not Completed 37 0
Reason Not Completed
Wish for pregnancy             14             0
Adverse Event             9             0
Withdrawal by Subject             7             0
Other unknown             4             0
Pregnancy             2             0
Lost to Follow-up             1             0
[1]
A total of 200 participants elected to enter this optional Extension Phase.
[2]
Optional Extension Phase was for LCS12 group only.
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131) Total
Hide Arm/Group Description Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles Total of all reporting groups
Overall Number of Baseline Participants 279 281 560
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 279 participants 281 participants 560 participants
23.7  (3.0) 23.9  (3.0) 23.8  (3.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 279 participants 281 participants 560 participants
Female
279
 100.0%
281
 100.0%
560
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Number of births  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 279 participants 281 participants 560 participants
0 216 206 422
1 39 49 88
2 19 24 43
3 4 2 6
4 1 0 1
1.Primary Outcome
Title Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)
Hide Description Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.
Time Frame At 18 months
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Hide Analysis Population Description
Full analysis set (only subjects with at least one assessment of the overall satisfaction rating)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 274 260
Measure Type: Number
Unit of Measure: Percentage of participants
82.1 81.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCS12 (Skyla, BAY86-5028)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter single proportion
Estimated Value 82.1
Confidence Interval (2-Sided) 95%
77.1 to 86.5
Estimation Comments Clopper Pearson Confidence Interval
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection EE30/DRSP (Yasmin, BAY86-5131)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter single proportion
Estimated Value 81.9
Confidence Interval (2-Sided) 95%
76.7 to 86.4
Estimation Comments Clopper Pearson Confidence Interval
2.Secondary Outcome
Title Overall Satisfaction Rating by the 5-point Likert Item at 6 Months
Hide Description Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 273 260
Measure Type: Number
Unit of Measure: Percentage of participants
Very Satisfied 60.4 48.1
Satisfied 27.5 35.8
Neither satisfied nor dissatisfied 7.3 9.6
Dissatisfied 1.8 6.2
Very Dissatisfied 2.9 0.4
3.Secondary Outcome
Title Overall Satisfaction Rating by the 5-point Likert Item at 12 Months
Hide Description Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.
Time Frame At 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 253 238
Measure Type: Number
Unit of Measure: Percentage of participants
Very Satisfied 66.8 45.0
Satisfied 22.9 44.1
Neither satisfied nor dissatisfied 5.9 5.9
Dissatisfied 4.3 3.8
Very Dissatisfied 0.0 1.3
4.Secondary Outcome
Title Overall Satisfaction Rating by the 5-point Likert Item at 18 Months
Hide Description Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.
Time Frame At 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 235 217
Measure Type: Number
Unit of Measure: Percentage of participants
Very Satisfied 64.3 52.5
Satisfied 25.1 37.8
Neither satisfied nor dissatisfied 6.4 6.9
Dissatisfied 3.0 2.8
Very Dissatisfied 1.3 0.0
5.Secondary Outcome
Title Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)
Hide Description

Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.

The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Time Frame At 18 months/EOS
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months/end of study)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 268 251
Measure Type: Number
Unit of Measure: Percentage of participants
Very Satisfied 58.6 46.6
Satisfied 23.5 35.1
Neither satisfied nor dissatisfied 8.6 9.6
Dissatisfied 5.6 7.6
Very Dissatisfied 3.7 1.2
6.Secondary Outcome
Title Overall Satisfaction Rate at 6 Months (LOCF)
Hide Description Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months or before)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 273 260
Measure Type: Number
Unit of Measure: Percentage of participants
87.9 83.8
7.Secondary Outcome
Title Overall Satisfaction Rate at 12 Months (LOCF)
Hide Description Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.
Time Frame At 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 274 260
Measure Type: Number
Unit of Measure: Percentage of participants
84.3 83.8
8.Secondary Outcome
Title User Satisfaction – Acceptability of the Administration of Study Treatment
Hide Description The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Time Frame At 18 months/EOS
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 263 250
Measure Type: Number
Unit of Measure: Participants
Acc. without inconvenience/discomfort 153 186
Acc. with some inconv/discomfort 87 46
Not acc. with moderate inconv./discomf. 11 15
Not acc. with extreme inconv./discomf 12 3
9.Secondary Outcome
Title User Satisfaction – Choices Upon Completion of the Study
Hide Description The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Time Frame At 18 months/EOS
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 263 248
Measure Type: Number
Unit of Measure: Participants
Continue with study treatment 174 122
Use a different hormonal contraceptive 34 51
Use a different contraceptive method 17 27
Discont. use of all types of contracept. 6 14
No need for contraceptive at this time 5 12
Undecided 27 22
10.Secondary Outcome
Title User Satisfaction – Amount of Menstrual Bleeding
Hide Description The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Time Frame At 18 months/EOS
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 260 250
Measure Type: Number
Unit of Measure: Participants
Decreased 80 35
Not Changed 163 207
Increased 17 8
11.Secondary Outcome
Title User Satisfaction – Satisfaction With Menstrual Bleeding Pattern
Hide Description The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Time Frame At 18 months/EOS
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 263 250
Measure Type: Number
Unit of Measure: Participants
Very satisfied 101 91
Somewhat satisfied 65 84
Neither satisfied nor dissatisfied 48 68
Dissatisfied 19 4
Very dissatisfied 10 1
Not applicable 20 2
12.Secondary Outcome
Title User Satisfaction – Frequency of Experiencing Unexpected Bleeding
Hide Description The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Time Frame At 18 months/EOS
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 263 250
Measure Type: Number
Unit of Measure: Participants
Never 145 219
Seldom 92 25
Often 17 5
Very Often 9 1
13.Secondary Outcome
Title User Satisfaction – Satisfaction With Menstrual Bleeding Absence
Hide Description The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Time Frame At 18 months/EOS
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 130 14
Measure Type: Number
Unit of Measure: Participants
Very satisfied 96 6
Somewhat satisfied 18 0
Neither satisfied nor dissatisfied 14 8
Dissatisfied 1 0
Very dissatisfied 1 0
14.Secondary Outcome
Title User Satisfaction – Comparison of Menstrual Pain Intensity Between Now and Before Treatment
Hide Description The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Time Frame At 18 months/EOS
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 259 247
Measure Type: Number
Unit of Measure: Participants
Decreased 118 61
Not changed 102 169
Increased 39 17
15.Secondary Outcome
Title User Satisfaction – Rating of Usual Menstrual Pain Intensity
Hide Description The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Time Frame At 18 months/EOS
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 261 249
Measure Type: Number
Unit of Measure: Participants
None 124 82
Mild 78 92
Moderate 43 67
Severe 16 8
16.Secondary Outcome
Title EVAPIL-R Scores at Screening - Composite Score
Hide Description The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.
Time Frame At screening
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the composite score could be calculated)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 273 275
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.9386  (0.8036) 0.8846  (0.8231)
17.Secondary Outcome
Title EVAPIL-R Scores at Screening - Bother Score
Hide Description The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, , with higher values indicating more severe symptoms/less tolerability.
Time Frame At screening
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the bother score could be calculated)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 273 276
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.5569  (0.4451) 0.5188  (0.4406)
18.Secondary Outcome
Title EVAPIL-R Scores at 6 Months
Hide Description The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 6 months where the scores could be calculated)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 252 243
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Composite score 1.3187  (0.9888) 1.1537  (0.9947)
Bother score 0.7364  (0.4940) 0.6550  (0.5148)
19.Secondary Outcome
Title EVAPIL-R Scores at 12 Months - Bother Score
Hide Description The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.
Time Frame At 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the bother score could be calculated)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 233 218
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.7789  (0.5120) 0.6015  (0.4663)
20.Secondary Outcome
Title EVAPIL-R Scores at 12 Months - Composite Score
Hide Description The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.
Time Frame At 12 months
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Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the composite score could be calculated)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 229 218
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1.4022  (1.0126) 1.0535  (0.8698)
21.Secondary Outcome
Title EVAPIL-R Scores at 18 Months/EOS
Hide Description The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.
Time Frame At 18 months/EOS
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Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 18 months/end of study where the scores could be calculated)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 260 250
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Composite score 1.4804  (1.1926) 1.0246  (0.9546)
Bother score 0.8113  (0.5765) 0.5908  (0.4836)
22.Secondary Outcome
Title Cumulative Drop-out Rate
Hide Description The drop-out rate is the amount of participants that could not complete the study for various reasons. Discontinuation rates due to the following reasons and overall discontinuations were calculated: • LCS12 expulsions • Bleeding pattern alterations • Bleeding pattern alterations with increased bleeding (amount) • Bleeding pattern alterations with decreased bleeding (amount) • Adverse Events The analyses described above were also done by parity. Furthermore, overall discontinuation rates were analyzed by Kaplan-Meier analyses and presented as cumulative half-yearly drop-out rates.
Time Frame Up to 6, 12, 18, 24 and 36 months
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Full analysis set
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 279 281
Measure Type: Number
Unit of Measure: Percentage of participants
Up to 6 months 7.53 11.39
Up to 12 months 13.26 21.71
Up to 18 months 18.64 27.40
Up to 24 months 30.85 NA [1] 
Up to 36 months 33.34 NA [1] 
[1]
Extension phase was only for LCS12 group
23.Secondary Outcome
Title Pearl Index (PI)
Hide Description The Pearl Index was defined as the number of pregnancies per 100 woman years (WYs). Given the assumption that the number of pregnancies follows a Poisson distribution, the Pearl Index thus is the mean of this distribution.
Time Frame Up to 18, 24, 36 months
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Full analysis set
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 279 281
Mean (95% Confidence Interval)
Unit of Measure: Pregnancies per 100 women years
Pearl index up to 18 months
0.57
(0.07 to 2.05)
1.82
(0.67 to 3.97)
Pearl index up to 24 months
0.67
(0.14 to 1.95)
NA [1] 
(NA to NA)
Pearl index up to 36 months
0.65
(0.18 to 1.67)
NA [1] 
(NA to NA)
[1]
Extension phase was only for LCS12 group.
24.Secondary Outcome
Title Compliance Rate for Yasmin Pill Intake
Hide Description [Not Specified]
Time Frame Up to 18 months
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Full analysis set
Arm/Group Title EE30/DRSP (Yasmin, BAY86-5131)
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Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 281
Measure Type: Number
Unit of Measure: Percentage of participants
Missing 2.8
Compliance <=75% 2.1
Compliance >75% 95.0
25.Secondary Outcome
Title User Satisfaction – Acceptability of the Administration of Study Treatment
Hide Description The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.
Time Frame At 6 months
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Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 6 months)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 256 244
Measure Type: Number
Unit of Measure: Participants
Acc. without inconvenience/discomfort 163 192
Acc. with some inconv/discomfort 87 48
Not acc. with moderate inconv./discomf. 4 4
Not acc. with extreme inconv./discomf. 2 0
26.Secondary Outcome
Title User Satisfaction – Acceptability of the Administration of Study Treatment
Hide Description The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.
Time Frame At 12 months
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Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 12 months)
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Overall Number of Participants Analyzed 237 220
Measure Type: Number
Unit of Measure: Participants
Acc. without inconvenience/discomfort 152 185
Acc. with some inconv/discomfort 74 33
Not acc. with moderate inconv./discomf. 9 2
Not acc. with extreme inconv./discomf. 1 0
27.Other Pre-specified Outcome
Title Cumulative Number of Participants With Partial or Total Expulsion
Hide Description Total expulsion is confirmed if the IUS is observed in the vagina, the IUS is not shown in the uterine cavity by ultrasound, and / or the subject confirms that the system was expelled. Partial expulsion is diagnosed if the IUS can be partially seen in the vagina or is displaced in the cervical canal.
Time Frame Up to 18, 24, 36 months
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Full analysis set
Arm/Group Title LCS12 (Skyla, BAY86-5028)
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Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Overall Number of Participants Analyzed 279
Measure Type: Number
Unit of Measure: Participants
Partial expulsion up to 18 months 0
Total expulsion up to 18 months 0
Partial expulsion up to 24 months 1
Total expulsion up to 24 months 0
Partial expulsion up to 36 months 1
Total expulsion up to 36 months 0
28.Other Pre-specified Outcome
Title Investigator's Evaluation of Successful IUS Insertion Procedure
Hide Description [Not Specified]
Time Frame Up to 18 months
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Full analysis set
Arm/Group Title LCS12 (Skyla, BAY86-5028)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Overall Number of Participants Analyzed 279
Measure Type: Number
Unit of Measure: Participants
Easy 247
Slightly difficult 31
Very difficult 1
29.Other Pre-specified Outcome
Title Participants’ Evaluation of Pain During Successful IUS Insertion Procedure
Hide Description [Not Specified]
Time Frame Up to 18 months
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Full analysis set
Arm/Group Title LCS12 (Skyla, BAY86-5028)
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Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Overall Number of Participants Analyzed 279
Measure Type: Number
Unit of Measure: Participants
None 49
Mild 125
Moderate 80
Severe 25
30.Other Pre-specified Outcome
Title Investigator's Evaluation of IUS Removal Procedure
Hide Description [Not Specified]
Time Frame Up to 36 months
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Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)
Arm/Group Title LCS12 (Skyla, BAY86-5028)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Overall Number of Participants Analyzed 267
Measure Type: Number
Unit of Measure: Participants
Easy 252
Slightly difficult 11
Very difficult 4
31.Other Pre-specified Outcome
Title Participants’ Evaluation of Pain During IUS Removal Procedure
Hide Description [Not Specified]
Time Frame Up to 36 months
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Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)
Arm/Group Title LCS12 (Skyla, BAY86-5028)
Hide Arm/Group Description:
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Overall Number of Participants Analyzed 267
Measure Type: Number
Unit of Measure: Participants
None 136
Mild 96
Moderate 30
Severe 5
Time Frame From start of treatment until 36 months/EOS visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Hide Arm/Group Description Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
All-Cause Mortality
LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Affected / at Risk (%) Affected / at Risk (%)
Total   22/279 (7.89%)   5/281 (1.78%) 
Endocrine disorders     
Basedow's disease * 1  1/279 (0.36%)  0/281 (0.00%) 
Basedow's disease * 2  1/279 (0.36%)  0/281 (0.00%) 
Gastrointestinal disorders     
Colitis ulcerative * 1  1/279 (0.36%)  0/281 (0.00%) 
Femoral hernia * 1  1/279 (0.36%)  0/281 (0.00%) 
Colitis ulcerative * 2  1/279 (0.36%)  0/281 (0.00%) 
Femoral hernia * 2  1/279 (0.36%)  0/281 (0.00%) 
General disorders     
Impaired healing * 1  0/279 (0.00%)  1/281 (0.36%) 
Impaired healing * 2  0/279 (0.00%)  1/281 (0.36%) 
Infections and infestations     
Appendicitis * 1  1/279 (0.36%)  2/281 (0.71%) 
Infectious mononucleosis * 1  0/279 (0.00%)  1/281 (0.36%) 
Appendicitis * 2  1/279 (0.36%)  2/281 (0.71%) 
Breast abscess * 2  1/279 (0.36%)  0/281 (0.00%) 
Infectious mononucleosis * 2  0/279 (0.00%)  1/281 (0.36%) 
Injury, poisoning and procedural complications     
Incisional hernia * 1  0/279 (0.00%)  1/281 (0.36%) 
Laceration * 1  1/279 (0.36%)  0/281 (0.00%) 
Muscle injury * 1  0/279 (0.00%)  1/281 (0.36%) 
Ligament rupture * 1  1/279 (0.36%)  0/281 (0.00%) 
Incisional hernia * 2  0/279 (0.00%)  1/281 (0.36%) 
Laceration * 2  1/279 (0.36%)  0/281 (0.00%) 
Muscle injury * 2  0/279 (0.00%)  1/281 (0.36%) 
Ligament rupture * 2  2/279 (0.72%)  0/281 (0.00%) 
Musculoskeletal and connective tissue disorders     
Exostosis * 1  1/279 (0.36%)  0/281 (0.00%) 
Nose deformity * 1  1/279 (0.36%)  0/281 (0.00%) 
Exostosis * 2  1/279 (0.36%)  0/281 (0.00%) 
Nose deformity * 2  1/279 (0.36%)  0/281 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant melanoma * 1  1/279 (0.36%)  0/281 (0.00%) 
Cervix carcinoma stage 0 * 1  1/279 (0.36%)  0/281 (0.00%) 
Borderline ovarian tumour * 2  1/279 (0.36%)  0/281 (0.00%) 
Malignant melanoma * 2  1/279 (0.36%)  0/281 (0.00%) 
Cervix carcinoma stage 0 * 2  1/279 (0.36%)  0/281 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  1/279 (0.36%)  1/281 (0.36%) 
Ectopic pregnancy * 1  1/279 (0.36%)  0/281 (0.00%) 
Abortion spontaneous * 2  1/279 (0.36%)  0/281 (0.00%) 
Ectopic pregnancy * 2  3/279 (1.08%)  0/281 (0.00%) 
Reproductive system and breast disorders     
Cervical dysplasia * 1  1/279 (0.36%)  0/281 (0.00%) 
Ovarian cyst * 1  1/279 (0.36%)  0/281 (0.00%) 
Breast fibrosis * 2  1/279 (0.36%)  0/281 (0.00%) 
Cervical dysplasia * 2  1/279 (0.36%)  0/281 (0.00%) 
Ovarian cyst * 2  1/279 (0.36%)  0/281 (0.00%) 
Surgical and medical procedures     
Breast prosthesis implantation * 2  1/279 (0.36%)  0/281 (0.00%) 
Myomectomy * 2  1/279 (0.36%)  0/281 (0.00%) 
Mammoplasty * 2  1/279 (0.36%)  0/281 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.1)
2
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
LCS12 (Skyla, BAY86-5028) EE30/DRSP (Yasmin, BAY86-5131)
Affected / at Risk (%) Affected / at Risk (%)
Total   215/279 (77.06%)   148/281 (52.67%) 
Ear and labyrinth disorders     
Vertigo * 1  3/279 (1.08%)  0/281 (0.00%) 
Vertigo * 2  3/279 (1.08%)  0/281 (0.00%) 
Endocrine disorders     
Hypothyroidism * 1  3/279 (1.08%)  2/281 (0.71%) 
Hypothyroidism * 2  3/279 (1.08%)  2/281 (0.71%) 
Gastrointestinal disorders     
Abdominal pain * 1  23/279 (8.24%)  4/281 (1.42%) 
Abdominal pain lower * 1  9/279 (3.23%)  5/281 (1.78%) 
Abdominal pain upper * 1  3/279 (1.08%)  6/281 (2.14%) 
Constipation * 1  0/279 (0.00%)  4/281 (1.42%) 
Diarrhoea * 1  1/279 (0.36%)  9/281 (3.20%) 
Gastritis * 1  4/279 (1.43%)  4/281 (1.42%) 
Gastrooesophageal reflux disease * 1  3/279 (1.08%)  3/281 (1.07%) 
Nausea * 1  9/279 (3.23%)  14/281 (4.98%) 
Toothache * 1  3/279 (1.08%)  2/281 (0.71%) 
Vomiting * 1  3/279 (1.08%)  8/281 (2.85%) 
Abdominal pain * 2  21/279 (7.53%)  4/281 (1.42%) 
Abdominal pain lower * 2  12/279 (4.30%)  5/281 (1.78%) 
Abdominal pain upper * 2  3/279 (1.08%)  6/281 (2.14%) 
Constipation * 2  0/279 (0.00%)  4/281 (1.42%) 
Diarrhoea * 2  1/279 (0.36%)  9/281 (3.20%) 
Gastritis * 2  5/279 (1.79%)  4/281 (1.42%) 
Gastrooesophageal reflux disease * 2  5/279 (1.79%)  3/281 (1.07%) 
Nausea * 2  9/279 (3.23%)  14/281 (4.98%) 
Toothache * 2  4/279 (1.43%)  2/281 (0.71%) 
Vomiting * 2  4/279 (1.43%)  8/281 (2.85%) 
General disorders     
Irritability * 1  3/279 (1.08%)  1/281 (0.36%) 
Pyrexia * 1  3/279 (1.08%)  2/281 (0.71%) 
Pyrexia * 2  3/279 (1.08%)  2/281 (0.71%) 
Infections and infestations     
Acute tonsillitis * 1  4/279 (1.43%)  6/281 (2.14%) 
Bronchitis * 1  4/279 (1.43%)  4/281 (1.42%) 
Cystitis * 1  17/279 (6.09%)  15/281 (5.34%) 
Gastroenteritis * 1  2/279 (0.72%)  4/281 (1.42%) 
Influenza * 1  2/279 (0.72%)  3/281 (1.07%) 
Nasopharyngitis * 1  17/279 (6.09%)  14/281 (4.98%) 
Sinusitis * 1  2/279 (0.72%)  6/281 (2.14%) 
Tonsillitis * 1  3/279 (1.08%)  4/281 (1.42%) 
Urinary tract infection * 1  11/279 (3.94%)  5/281 (1.78%) 
Vaginal infection * 1  8/279 (2.87%)  7/281 (2.49%) 
Vulvitis * 1  3/279 (1.08%)  0/281 (0.00%) 
Vulvovaginal candidiasis * 1  13/279 (4.66%)  7/281 (2.49%) 
Vulvovaginitis * 1  2/279 (0.72%)  3/281 (1.07%) 
Tooth infection * 1  0/279 (0.00%)  3/281 (1.07%) 
Vaginitis bacterial * 1  9/279 (3.23%)  3/281 (1.07%) 
Vulvovaginal mycotic infection * 1  8/279 (2.87%)  7/281 (2.49%) 
Vulvovaginitis streptococcal * 1  3/279 (1.08%)  0/281 (0.00%) 
Acute tonsillitis * 2  5/279 (1.79%)  6/281 (2.14%) 
Bacterial vaginosis * 2  18/279 (6.45%)  3/281 (1.07%) 
Bronchitis * 2  5/279 (1.79%)  4/281 (1.42%) 
Cystitis * 2  23/279 (8.24%)  15/281 (5.34%) 
Ear infection * 2  3/279 (1.08%)  0/281 (0.00%) 
Gastroenteritis * 2  5/279 (1.79%)  4/281 (1.42%) 
Gonorrhoea * 2  3/279 (1.08%)  0/281 (0.00%) 
Influenza * 2  5/279 (1.79%)  3/281 (1.07%) 
Nasopharyngitis * 2  22/279 (7.89%)  13/281 (4.63%) 
Sinusitis * 2  3/279 (1.08%)  6/281 (2.14%) 
Tonsillitis * 2  7/279 (2.51%)  4/281 (1.42%) 
Urinary tract infection * 2  14/279 (5.02%)  4/281 (1.42%) 
Vaginal infection * 2  11/279 (3.94%)  7/281 (2.49%) 
Vaginitis gardnerella * 2  4/279 (1.43%)  1/281 (0.36%) 
Vulvitis * 2  3/279 (1.08%)  0/281 (0.00%) 
Vulvovaginal candidiasis * 2  15/279 (5.38%)  6/281 (2.14%) 
Vulvovaginitis * 2  4/279 (1.43%)  3/281 (1.07%) 
Tooth infection * 2  0/279 (0.00%)  3/281 (1.07%) 
Chlamydial infection * 2  3/279 (1.08%)  1/281 (0.36%) 
Vulvovaginal mycotic infection * 2  10/279 (3.58%)  7/281 (2.49%) 
Vulvovaginitis streptococcal * 2  3/279 (1.08%)  0/281 (0.00%) 
Vaginitis chlamydial * 2  3/279 (1.08%)  0/281 (0.00%) 
Candida infection * 2  4/279 (1.43%)  2/281 (0.71%) 
Injury, poisoning and procedural complications     
Contusion * 1  0/279 (0.00%)  3/281 (1.07%) 
Procedural pain * 1  10/279 (3.58%)  1/281 (0.36%) 
Joint dislocation * 2  4/279 (1.43%)  0/281 (0.00%) 
Contusion * 2  0/279 (0.00%)  3/281 (1.07%) 
Procedural pain * 2  10/279 (3.58%)  1/281 (0.36%) 
Investigations     
Smear cervix abnormal * 1  5/279 (1.79%)  0/281 (0.00%) 
Weight decreased * 1  1/279 (0.36%)  3/281 (1.07%) 
Weight increased * 1  7/279 (2.51%)  8/281 (2.85%) 
Human papilloma virus test positive * 1  4/279 (1.43%)  3/281 (1.07%) 
Smear cervix abnormal * 2  5/279 (1.79%)  0/281 (0.00%) 
Weight decreased * 2  3/279 (1.08%)  3/281 (1.07%) 
Weight increased * 2  10/279 (3.58%)  8/281 (2.85%) 
Human papilloma virus test positive * 2  5/279 (1.79%)  3/281 (1.07%) 
Chlamydia test positive * 2  4/279 (1.43%)  2/281 (0.71%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  6/279 (2.15%)  4/281 (1.42%) 
Back pain * 2  8/279 (2.87%)  4/281 (1.42%) 
Nervous system disorders     
Headache * 1  21/279 (7.53%)  33/281 (11.74%) 
Migraine * 1  2/279 (0.72%)  5/281 (1.78%) 
Headache * 2  26/279 (9.32%)  32/281 (11.39%) 
Migraine * 2  2/279 (0.72%)  5/281 (1.78%) 
Psychiatric disorders     
Depression * 1  1/279 (0.36%)  4/281 (1.42%) 
Insomnia * 1  0/279 (0.00%)  4/281 (1.42%) 
Libido decreased * 1  1/279 (0.36%)  3/281 (1.07%) 
Mood altered * 1  1/279 (0.36%)  3/281 (1.07%) 
Depression * 2  2/279 (0.72%)  4/281 (1.42%) 
Insomnia * 2  0/279 (0.00%)  4/281 (1.42%) 
Irritability * 2  3/279 (1.08%)  1/281 (0.36%) 
Libido decreased * 2  3/279 (1.08%)  3/281 (1.07%) 
Mood altered * 2  1/279 (0.36%)  3/281 (1.07%) 
Reproductive system and breast disorders     
Breast pain * 1  3/279 (1.08%)  1/281 (0.36%) 
Breast tenderness * 1  3/279 (1.08%)  2/281 (0.71%) 
Cervical dysplasia * 1  25/279 (8.96%)  16/281 (5.69%) 
Dysmenorrhoea * 1  48/279 (17.20%)  26/281 (9.25%) 
Menorrhagia * 1  5/279 (1.79%)  5/281 (1.78%) 
Metrorrhagia * 1  9/279 (3.23%)  1/281 (0.36%) 
Ovarian cyst * 1  19/279 (6.81%)  0/281 (0.00%) 
Pelvic pain * 1  13/279 (4.66%)  0/281 (0.00%) 
Vaginal discharge * 1  6/279 (2.15%)  1/281 (0.36%) 
Vaginal haemorrhage * 1  6/279 (2.15%)  0/281 (0.00%) 
Genital haemorrhage * 1  6/279 (2.15%)  0/281 (0.00%) 
Coital bleeding * 1  3/279 (1.08%)  1/281 (0.36%) 
Breast pain * 2  3/279 (1.08%)  1/281 (0.36%) 
Breast tenderness * 2  3/279 (1.08%)  2/281 (0.71%) 
Cervical dysplasia * 2  35/279 (12.54%)  16/281 (5.69%) 
Dysmenorrhoea * 2  47/279 (16.85%)  26/281 (9.25%) 
Dyspareunia * 2  4/279 (1.43%)  0/281 (0.00%) 
Menorrhagia * 2  6/279 (2.15%)  5/281 (1.78%) 
Metrorrhagia * 2  10/279 (3.58%)  1/281 (0.36%) 
Ovarian cyst * 2  18/279 (6.45%)  0/281 (0.00%) 
Ovarian cyst ruptured * 2  4/279 (1.43%)  0/281 (0.00%) 
Pelvic pain * 2  13/279 (4.66%)  0/281 (0.00%) 
Vaginal discharge * 2  12/279 (4.30%)  0/281 (0.00%) 
Vaginal haemorrhage * 2  8/279 (2.87%)  0/281 (0.00%) 
Vulvovaginal pruritus * 2  3/279 (1.08%)  1/281 (0.36%) 
Genital haemorrhage * 2  6/279 (2.15%)  0/281 (0.00%) 
Coital bleeding * 2  5/279 (1.79%)  1/281 (0.36%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/279 (0.36%)  3/281 (1.07%) 
Oropharyngeal pain * 1  5/279 (1.79%)  2/281 (0.71%) 
Cough * 2  2/279 (0.72%)  3/281 (1.07%) 
Oropharyngeal pain * 2  7/279 (2.51%)  2/281 (0.71%) 
Skin and subcutaneous tissue disorders     
Acne * 1  30/279 (10.75%)  6/281 (2.14%) 
Skin disorder * 1  3/279 (1.08%)  0/281 (0.00%) 
Acne * 2  34/279 (12.19%)  6/281 (2.14%) 
Rash * 2  3/279 (1.08%)  0/281 (0.00%) 
Skin disorder * 2  3/279 (1.08%)  0/281 (0.00%) 
Surgical and medical procedures     
Wisdom teeth removal * 1  4/279 (1.43%)  1/281 (0.36%) 
Wisdom teeth removal * 2  5/279 (1.79%)  1/281 (0.36%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.1)
2
Term from vocabulary, MedDRA (17.0)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Bayer AG
EMail: clinical-trials-contact@bayer.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01254292     History of Changes
Other Study ID Numbers: 13362
2010-020181-21 ( EudraCT Number )
First Submitted: November 22, 2010
First Posted: December 6, 2010
Results First Submitted: January 7, 2014
Results First Posted: April 7, 2014
Last Update Posted: September 25, 2017