Contraception
Conditions
Brief summary
The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional, extension phase. Safety data only will be collected during the extension phase of the study. Secondary objectives are to observe the tolerability, discontinuation rates, adverse event profiles, occurrences of unintended pregnancies (including calculation of Pearl Index \[PI\]), and bleeding profiles with the two birth-control methods. Additionally, data on missed tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of subjects) will be collected. Finally, in the COC group, information will be collected on the psychosocial impact of missed or delayed pill intake.
Interventions
DRUGLevonorgestrel IUD (LCS, BAY86-5028)
LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 18 months with optional extension to 36 months for subjects in this group only.
DRUGYasmin (EE30/DRSP, BAY86-5131)
Combined oral contraceptive (COC; Yasmin; 0.03 mg ethinyl estradiol and 3 mg drospirenone); Subjects will start taking COC at / on the day of visit 2 and continue taking one pill / day without any breaks for the entire study duration of 18 months.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* Subject has signed and dated the Informed Consent Form (ICF). * The subject is generally healthy, requesting contraception, and is between 18 and 29 years of age (inclusive) at Screening. * In the opinion of the investigator, the subject is * in good health; * without uterine conditions that would preempt insertion of LCS12; * without conditions/history that would contraindicate the use of oral contraceptives. * Subject has normal or clinically insignificant cervical smear (ie, one that does not require further follow up). A cervical smear must be taken at the Screening Visit or a documented normal result has to have been obtained within 6 months of Screening. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) deoxyribonucleic acid (DNA) test that, according to the standards of the local laboratory, is negative for high-risk HPV. * As determined by subject's history, subject has regular (ie, endogenous cyclicity without hormonal contraceptive use) menstrual cycles (length of cycle 21-35 days). * Subject is willing and able to attend the scheduled study visits and to comply with the study procedures.
Exclusion criteria
* Pregnancy or current lactation (less than 6 weeks since vaginal or Cesarean delivery or abortion). Note: Postpartum LCS12 insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, the investigator should consider waiting until 12 weeks postpartum. * Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit (Visit 1) * Chronic, daily use of drugs that may increase serum potassium levels, such as nonsteroidal anti-inflammatory drugs (NSAIDs, eg. ibuprofen and naproxen), potassium-sparing diuretics (eg. spironolactone), potassium supplementation, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, aldosterone antagonists, and heparin. * Abnormal uterine bleeding of unknown origin/undiagnosed abnormal genital bleeding * Any genital infection (until successfully treated) * Abnormal cervical smear result (see inclusion criteria) * Acute, current or history of recurrent pelvic inflammatory disease * Congenital or acquired uterine anomaly or any distortion of the uterine cavity (eg, by fibroids) that, in the opinion of the investigator, would cause problems during insertion, retention, or removal of LCS12.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF) | At 18 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User Satisfaction - Satisfaction With Menstrual Bleeding Pattern | At 18 months/EOS | 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. |
| EVAPIL-R Scores at 12 Months - Composite Score | At 12 months | 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. |
| EVAPIL-R Scores at 18 Months/EOS | At 18 months/EOS | 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. |
| Cumulative Drop-out Rate | Up to 6, 12, 18, 24 and 36 months | 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. |
| Pearl Index (PI) | Up to 18, 24, 36 months | 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. |
| Compliance Rate for Yasmin Pill Intake | Up to 18 months | — |
| Overall Satisfaction Rating by the 5-point Likert Item at 6 Months | At 6 months | 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. |
| Overall Satisfaction Rating by the 5-point Likert Item at 12 Months | At 12 months | 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. |
| Overall Satisfaction Rating by the 5-point Likert Item at 18 Months | At 18 months | 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. |
| Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS) | At 18 months/EOS | 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. |
| Overall Satisfaction Rate at 6 Months (LOCF) | At 6 months | 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. |
| Overall Satisfaction Rate at 12 Months (LOCF) | At 12 months | 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. |
| User Satisfaction - Acceptability of the Administration of Study Treatment | At 18 months/EOS | 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. |
| User Satisfaction - Choices Upon Completion of the Study | At 18 months/EOS | 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. |
| User Satisfaction - Amount of Menstrual Bleeding | At 18 months/EOS | 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. |
| User Satisfaction - Frequency of Experiencing Unexpected Bleeding | At 18 months/EOS | 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. |
| User Satisfaction - Satisfaction With Menstrual Bleeding Absence | At 18 months/EOS | 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. |
| User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment | At 18 months/EOS | 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. |
| User Satisfaction - Rating of Usual Menstrual Pain Intensity | At 18 months/EOS | 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. |
| EVAPIL-R Scores at Screening - Composite Score | At screening | 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. |
| EVAPIL-R Scores at Screening - Bother Score | At screening | 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. |
| EVAPIL-R Scores at 6 Months | At 6 months | 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. |
| EVAPIL-R Scores at 12 Months - Bother Score | At 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participants' Evaluation of Pain During Successful IUS Insertion Procedure | Up to 18 months | — |
| Investigator's Evaluation of IUS Removal Procedure | Up to 36 months | — |
| Participants' Evaluation of Pain During IUS Removal Procedure | Up to 36 months | — |
| Investigator's Evaluation of Successful IUS Insertion Procedure | Up to 18 months | — |
| Cumulative Number of Participants With Partial or Total Expulsion | Up to 18, 24, 36 months | 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. |
Countries
Austria, Belgium, Germany, Russia, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| LCS12 (Skyla, BAY86-5028) 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 | 279 |
| EE30/DRSP (Yasmin, BAY86-5131) Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles | 281 |
| Total | 560 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Comparative Phase | Adverse Event | 25 | 25 |
| Comparative Phase | Lost to Follow-up | 3 | 21 |
| Comparative Phase | Pregnancy | 2 | 6 |
| Comparative Phase | Protocol Violation | 1 | 2 |
| Comparative Phase | Wish for pregnancy | 4 | 6 |
| Comparative Phase | Withdrawal by Subject | 20 | 21 |
| LCS12 Extension Phase | Adverse Event | 9 | 0 |
| LCS12 Extension Phase | Lost to Follow-up | 1 | 0 |
| LCS12 Extension Phase | Other unknown | 4 | 0 |
| LCS12 Extension Phase | Pregnancy | 2 | 0 |
| LCS12 Extension Phase | Wish for pregnancy | 14 | 0 |
| LCS12 Extension Phase | Withdrawal by Subject | 7 | 0 |
Baseline characteristics
| Characteristic | EE30/DRSP (Yasmin, BAY86-5131) | Total | LCS12 (Skyla, BAY86-5028) |
|---|---|---|---|
| Age, Continuous | 23.9 Years STANDARD_DEVIATION 3 | 23.8 Years STANDARD_DEVIATION 3 | 23.7 Years STANDARD_DEVIATION 3 |
| Number of births 0 | 206 Participants | 422 Participants | 216 Participants |
| Number of births 1 | 49 Participants | 88 Participants | 39 Participants |
| Number of births 2 | 24 Participants | 43 Participants | 19 Participants |
| Number of births 3 | 2 Participants | 6 Participants | 4 Participants |
| Number of births 4 | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 281 Participants | 560 Participants | 279 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 215 / 279 | 148 / 281 |
| serious Total, serious adverse events | 22 / 279 | 5 / 281 |
Outcome results
Primary
Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)
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
Population: Full analysis set (only subjects with at least one assessment of the overall satisfaction rating)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF) | 82.1 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF) | 81.9 Percentage of participants |
95% CI: [77.1, 86.5]
95% CI: [76.7, 86.4]
Secondary
Compliance Rate for Yasmin Pill Intake
Time frame: Up to 18 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Compliance Rate for Yasmin Pill Intake | Missing | 2.8 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Compliance Rate for Yasmin Pill Intake | Compliance <=75% | 2.1 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Compliance Rate for Yasmin Pill Intake | Compliance >75% | 95.0 Percentage of participants |
Secondary
Cumulative Drop-out Rate
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
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Cumulative Drop-out Rate | Up to 12 months | 13.26 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Cumulative Drop-out Rate | Up to 24 months | 30.85 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Cumulative Drop-out Rate | Up to 18 months | 18.64 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Cumulative Drop-out Rate | Up to 36 months | 33.34 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Cumulative Drop-out Rate | Up to 6 months | 7.53 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Cumulative Drop-out Rate | Up to 36 months | NA Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Cumulative Drop-out Rate | Up to 6 months | 11.39 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Cumulative Drop-out Rate | Up to 12 months | 21.71 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Cumulative Drop-out Rate | Up to 18 months | 27.40 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Cumulative Drop-out Rate | Up to 24 months | NA Percentage of participants |
Secondary
EVAPIL-R Scores at 12 Months - Bother Score
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
Population: Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the bother score could be calculated)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | EVAPIL-R Scores at 12 Months - Bother Score | 0.7789 Scores on a scale | Standard Deviation 0.512 |
| EE30/DRSP (Yasmin, BAY86-5131) | EVAPIL-R Scores at 12 Months - Bother Score | 0.6015 Scores on a scale | Standard Deviation 0.4663 |
Secondary
EVAPIL-R Scores at 12 Months - Composite Score
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
Population: Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the composite score could be calculated)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | EVAPIL-R Scores at 12 Months - Composite Score | 1.4022 Scores on a scale | Standard Deviation 1.0126 |
| EE30/DRSP (Yasmin, BAY86-5131) | EVAPIL-R Scores at 12 Months - Composite Score | 1.0535 Scores on a scale | Standard Deviation 0.8698 |
Secondary
EVAPIL-R Scores at 18 Months/EOS
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | EVAPIL-R Scores at 18 Months/EOS | Composite score | 1.4804 Scores on a scale | Standard Deviation 1.1926 |
| LCS12 (Skyla, BAY86-5028) | EVAPIL-R Scores at 18 Months/EOS | Bother score | 0.8113 Scores on a scale | Standard Deviation 0.5765 |
| EE30/DRSP (Yasmin, BAY86-5131) | EVAPIL-R Scores at 18 Months/EOS | Composite score | 1.0246 Scores on a scale | Standard Deviation 0.9546 |
| EE30/DRSP (Yasmin, BAY86-5131) | EVAPIL-R Scores at 18 Months/EOS | Bother score | 0.5908 Scores on a scale | Standard Deviation 0.4836 |
Secondary
EVAPIL-R Scores at 6 Months
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
Population: Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 6 months where the scores could be calculated)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | EVAPIL-R Scores at 6 Months | Composite score | 1.3187 Scores on a scale | Standard Deviation 0.9888 |
| LCS12 (Skyla, BAY86-5028) | EVAPIL-R Scores at 6 Months | Bother score | 0.7364 Scores on a scale | Standard Deviation 0.494 |
| EE30/DRSP (Yasmin, BAY86-5131) | EVAPIL-R Scores at 6 Months | Composite score | 1.1537 Scores on a scale | Standard Deviation 0.9947 |
| EE30/DRSP (Yasmin, BAY86-5131) | EVAPIL-R Scores at 6 Months | Bother score | 0.6550 Scores on a scale | Standard Deviation 0.5148 |
Secondary
EVAPIL-R Scores at Screening - Bother Score
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
Population: Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the bother score could be calculated)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | EVAPIL-R Scores at Screening - Bother Score | 0.5569 Scores on a scale | Standard Deviation 0.4451 |
| EE30/DRSP (Yasmin, BAY86-5131) | EVAPIL-R Scores at Screening - Bother Score | 0.5188 Scores on a scale | Standard Deviation 0.4406 |
Secondary
EVAPIL-R Scores at Screening - Composite Score
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
Population: Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the composite score could be calculated)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | EVAPIL-R Scores at Screening - Composite Score | 0.9386 Scores on a scale | Standard Deviation 0.8036 |
| EE30/DRSP (Yasmin, BAY86-5131) | EVAPIL-R Scores at Screening - Composite Score | 0.8846 Scores on a scale | Standard Deviation 0.8231 |
Secondary
Overall Satisfaction Rate at 12 Months (LOCF)
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
Population: Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rate at 12 Months (LOCF) | 84.3 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rate at 12 Months (LOCF) | 83.8 Percentage of participants |
Secondary
Overall Satisfaction Rate at 6 Months (LOCF)
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
Population: Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months or before)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rate at 6 Months (LOCF) | 87.9 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rate at 6 Months (LOCF) | 83.8 Percentage of participants |
Secondary
Overall Satisfaction Rating by the 5-point Likert Item at 12 Months
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
Population: Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 12 Months | Satisfied | 22.9 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 12 Months | Dissatisfied | 4.3 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 12 Months | Neither satisfied nor dissatisfied | 5.9 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 12 Months | Very Dissatisfied | 0.0 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 12 Months | Very Satisfied | 66.8 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 12 Months | Very Dissatisfied | 1.3 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 12 Months | Very Satisfied | 45.0 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 12 Months | Satisfied | 44.1 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 12 Months | Neither satisfied nor dissatisfied | 5.9 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 12 Months | Dissatisfied | 3.8 Percentage of participants |
Secondary
Overall Satisfaction Rating by the 5-point Likert Item at 18 Months
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
Population: Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 18 Months | Very Dissatisfied | 1.3 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 18 Months | Very Satisfied | 64.3 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 18 Months | Satisfied | 25.1 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 18 Months | Neither satisfied nor dissatisfied | 6.4 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 18 Months | Dissatisfied | 3.0 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 18 Months | Dissatisfied | 2.8 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 18 Months | Neither satisfied nor dissatisfied | 6.9 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 18 Months | Very Satisfied | 52.5 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 18 Months | Very Dissatisfied | 0.0 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 18 Months | Satisfied | 37.8 Percentage of participants |
Secondary
Overall Satisfaction Rating by the 5-point Likert Item at 6 Months
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
Population: Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 6 Months | Satisfied | 27.5 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 6 Months | Dissatisfied | 1.8 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 6 Months | Neither satisfied nor dissatisfied | 7.3 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 6 Months | Very Dissatisfied | 2.9 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at 6 Months | Very Satisfied | 60.4 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 6 Months | Very Dissatisfied | 0.4 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 6 Months | Very Satisfied | 48.1 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 6 Months | Satisfied | 35.8 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 6 Months | Neither satisfied nor dissatisfied | 9.6 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at 6 Months | Dissatisfied | 6.2 Percentage of participants |
Secondary
Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)
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
Population: Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months/end of study)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS) | Satisfied | 23.5 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS) | Dissatisfied | 5.6 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS) | Neither satisfied nor dissatisfied | 8.6 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS) | Very Dissatisfied | 3.7 Percentage of participants |
| LCS12 (Skyla, BAY86-5028) | Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS) | Very Satisfied | 58.6 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS) | Very Dissatisfied | 1.2 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS) | Very Satisfied | 46.6 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS) | Satisfied | 35.1 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS) | Neither satisfied nor dissatisfied | 9.6 Percentage of participants |
| EE30/DRSP (Yasmin, BAY86-5131) | Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS) | Dissatisfied | 7.6 Percentage of participants |
Secondary
Pearl Index (PI)
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
Population: Full analysis set
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Pearl Index (PI) | Pearl index up to 18 months | 0.57 Pregnancies per 100 women years |
| LCS12 (Skyla, BAY86-5028) | Pearl Index (PI) | Pearl index up to 24 months | 0.67 Pregnancies per 100 women years |
| LCS12 (Skyla, BAY86-5028) | Pearl Index (PI) | Pearl index up to 36 months | 0.65 Pregnancies per 100 women years |
| EE30/DRSP (Yasmin, BAY86-5131) | Pearl Index (PI) | Pearl index up to 18 months | 1.82 Pregnancies per 100 women years |
| EE30/DRSP (Yasmin, BAY86-5131) | Pearl Index (PI) | Pearl index up to 24 months | NA Pregnancies per 100 women years |
| EE30/DRSP (Yasmin, BAY86-5131) | Pearl Index (PI) | Pearl index up to 36 months | NA Pregnancies per 100 women years |
Secondary
User Satisfaction - Acceptability of the Administration of Study Treatment
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
Population: Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 12 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Acceptability of the Administration of Study Treatment | Acc. without inconvenience/discomfort | 152 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Acceptability of the Administration of Study Treatment | Not acc. with moderate inconv./discomf. | 9 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Acceptability of the Administration of Study Treatment | Acc. with some inconv/discomfort | 74 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Acceptability of the Administration of Study Treatment | Not acc. with extreme inconv./discomf. | 1 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Acceptability of the Administration of Study Treatment | Acc. with some inconv/discomfort | 33 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Acceptability of the Administration of Study Treatment | Acc. without inconvenience/discomfort | 185 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Acceptability of the Administration of Study Treatment | Not acc. with extreme inconv./discomf. | 0 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Acceptability of the Administration of Study Treatment | Not acc. with moderate inconv./discomf. | 2 Participants |
Secondary
User Satisfaction - Acceptability of the Administration of Study Treatment
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
Population: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Acceptability of the Administration of Study Treatment | Acc. without inconvenience/discomfort | 153 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Acceptability of the Administration of Study Treatment | Acc. with some inconv/discomfort | 87 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Acceptability of the Administration of Study Treatment | Not acc. with moderate inconv./discomf. | 11 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Acceptability of the Administration of Study Treatment | Not acc. with extreme inconv./discomf | 12 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Acceptability of the Administration of Study Treatment | Not acc. with extreme inconv./discomf | 3 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Acceptability of the Administration of Study Treatment | Acc. without inconvenience/discomfort | 186 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Acceptability of the Administration of Study Treatment | Not acc. with moderate inconv./discomf. | 15 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Acceptability of the Administration of Study Treatment | Acc. with some inconv/discomfort | 46 Participants |
Secondary
User Satisfaction - Acceptability of the Administration of Study Treatment
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
Population: Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 6 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Acceptability of the Administration of Study Treatment | Acc. without inconvenience/discomfort | 163 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Acceptability of the Administration of Study Treatment | Acc. with some inconv/discomfort | 87 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Acceptability of the Administration of Study Treatment | Not acc. with moderate inconv./discomf. | 4 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Acceptability of the Administration of Study Treatment | Not acc. with extreme inconv./discomf. | 2 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Acceptability of the Administration of Study Treatment | Not acc. with extreme inconv./discomf. | 0 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Acceptability of the Administration of Study Treatment | Acc. without inconvenience/discomfort | 192 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Acceptability of the Administration of Study Treatment | Not acc. with moderate inconv./discomf. | 4 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Acceptability of the Administration of Study Treatment | Acc. with some inconv/discomfort | 48 Participants |
Secondary
User Satisfaction - Amount of Menstrual Bleeding
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
Population: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Amount of Menstrual Bleeding | Decreased | 80 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Amount of Menstrual Bleeding | Not Changed | 163 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Amount of Menstrual Bleeding | Increased | 17 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Amount of Menstrual Bleeding | Increased | 8 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Amount of Menstrual Bleeding | Decreased | 35 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Amount of Menstrual Bleeding | Not Changed | 207 Participants |
Secondary
User Satisfaction - Choices Upon Completion of the Study
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
Population: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Choices Upon Completion of the Study | Continue with study treatment | 174 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Choices Upon Completion of the Study | Use a different hormonal contraceptive | 34 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Choices Upon Completion of the Study | Use a different contraceptive method | 17 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Choices Upon Completion of the Study | Discont. use of all types of contracept. | 6 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Choices Upon Completion of the Study | No need for contraceptive at this time | 5 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Choices Upon Completion of the Study | Undecided | 27 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Choices Upon Completion of the Study | No need for contraceptive at this time | 12 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Choices Upon Completion of the Study | Continue with study treatment | 122 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Choices Upon Completion of the Study | Discont. use of all types of contracept. | 14 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Choices Upon Completion of the Study | Use a different hormonal contraceptive | 51 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Choices Upon Completion of the Study | Undecided | 22 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Choices Upon Completion of the Study | Use a different contraceptive method | 27 Participants |
Secondary
User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment
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
Population: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment | Decreased | 118 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment | Not changed | 102 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment | Increased | 39 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment | Decreased | 61 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment | Not changed | 169 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment | Increased | 17 Participants |
Secondary
User Satisfaction - Frequency of Experiencing Unexpected Bleeding
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
Population: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Frequency of Experiencing Unexpected Bleeding | Never | 145 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Frequency of Experiencing Unexpected Bleeding | Seldom | 92 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Frequency of Experiencing Unexpected Bleeding | Often | 17 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Frequency of Experiencing Unexpected Bleeding | Very Often | 9 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Frequency of Experiencing Unexpected Bleeding | Very Often | 1 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Frequency of Experiencing Unexpected Bleeding | Never | 219 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Frequency of Experiencing Unexpected Bleeding | Often | 5 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Frequency of Experiencing Unexpected Bleeding | Seldom | 25 Participants |
Secondary
User Satisfaction - Rating of Usual Menstrual Pain Intensity
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
Population: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Rating of Usual Menstrual Pain Intensity | None | 124 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Rating of Usual Menstrual Pain Intensity | Mild | 78 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Rating of Usual Menstrual Pain Intensity | Moderate | 43 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Rating of Usual Menstrual Pain Intensity | Severe | 16 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Rating of Usual Menstrual Pain Intensity | Severe | 8 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Rating of Usual Menstrual Pain Intensity | None | 82 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Rating of Usual Menstrual Pain Intensity | Moderate | 67 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Rating of Usual Menstrual Pain Intensity | Mild | 92 Participants |
Secondary
User Satisfaction - Satisfaction With Menstrual Bleeding Absence
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
Population: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Satisfaction With Menstrual Bleeding Absence | Somewhat satisfied | 18 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Satisfaction With Menstrual Bleeding Absence | Dissatisfied | 1 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Satisfaction With Menstrual Bleeding Absence | Neither satisfied nor dissatisfied | 14 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Satisfaction With Menstrual Bleeding Absence | Very dissatisfied | 1 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Satisfaction With Menstrual Bleeding Absence | Very satisfied | 96 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Satisfaction With Menstrual Bleeding Absence | Very dissatisfied | 0 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Satisfaction With Menstrual Bleeding Absence | Very satisfied | 6 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Satisfaction With Menstrual Bleeding Absence | Somewhat satisfied | 0 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Satisfaction With Menstrual Bleeding Absence | Neither satisfied nor dissatisfied | 8 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Satisfaction With Menstrual Bleeding Absence | Dissatisfied | 0 Participants |
Secondary
User Satisfaction - Satisfaction With Menstrual Bleeding Pattern
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
Population: Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Satisfaction With Menstrual Bleeding Pattern | Very satisfied | 101 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Satisfaction With Menstrual Bleeding Pattern | Somewhat satisfied | 65 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Satisfaction With Menstrual Bleeding Pattern | Neither satisfied nor dissatisfied | 48 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Satisfaction With Menstrual Bleeding Pattern | Dissatisfied | 19 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Satisfaction With Menstrual Bleeding Pattern | Very dissatisfied | 10 Participants |
| LCS12 (Skyla, BAY86-5028) | User Satisfaction - Satisfaction With Menstrual Bleeding Pattern | Not applicable | 20 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Satisfaction With Menstrual Bleeding Pattern | Very dissatisfied | 1 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Satisfaction With Menstrual Bleeding Pattern | Very satisfied | 91 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Satisfaction With Menstrual Bleeding Pattern | Dissatisfied | 4 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Satisfaction With Menstrual Bleeding Pattern | Somewhat satisfied | 84 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Satisfaction With Menstrual Bleeding Pattern | Not applicable | 2 Participants |
| EE30/DRSP (Yasmin, BAY86-5131) | User Satisfaction - Satisfaction With Menstrual Bleeding Pattern | Neither satisfied nor dissatisfied | 68 Participants |
Other Pre-specified
Cumulative Number of Participants With Partial or Total Expulsion
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
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Cumulative Number of Participants With Partial or Total Expulsion | Partial expulsion up to 18 months | 0 Participants |
| LCS12 (Skyla, BAY86-5028) | Cumulative Number of Participants With Partial or Total Expulsion | Total expulsion up to 18 months | 0 Participants |
| LCS12 (Skyla, BAY86-5028) | Cumulative Number of Participants With Partial or Total Expulsion | Partial expulsion up to 24 months | 1 Participants |
| LCS12 (Skyla, BAY86-5028) | Cumulative Number of Participants With Partial or Total Expulsion | Total expulsion up to 24 months | 0 Participants |
| LCS12 (Skyla, BAY86-5028) | Cumulative Number of Participants With Partial or Total Expulsion | Partial expulsion up to 36 months | 1 Participants |
| LCS12 (Skyla, BAY86-5028) | Cumulative Number of Participants With Partial or Total Expulsion | Total expulsion up to 36 months | 0 Participants |
Other Pre-specified
Investigator's Evaluation of IUS Removal Procedure
Time frame: Up to 36 months
Population: Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Investigator's Evaluation of IUS Removal Procedure | Easy | 252 Participants |
| LCS12 (Skyla, BAY86-5028) | Investigator's Evaluation of IUS Removal Procedure | Slightly difficult | 11 Participants |
| LCS12 (Skyla, BAY86-5028) | Investigator's Evaluation of IUS Removal Procedure | Very difficult | 4 Participants |
Other Pre-specified
Investigator's Evaluation of Successful IUS Insertion Procedure
Time frame: Up to 18 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Investigator's Evaluation of Successful IUS Insertion Procedure | Easy | 247 Participants |
| LCS12 (Skyla, BAY86-5028) | Investigator's Evaluation of Successful IUS Insertion Procedure | Slightly difficult | 31 Participants |
| LCS12 (Skyla, BAY86-5028) | Investigator's Evaluation of Successful IUS Insertion Procedure | Very difficult | 1 Participants |
Other Pre-specified
Participants' Evaluation of Pain During IUS Removal Procedure
Time frame: Up to 36 months
Population: Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Participants' Evaluation of Pain During IUS Removal Procedure | Severe | 5 Participants |
| LCS12 (Skyla, BAY86-5028) | Participants' Evaluation of Pain During IUS Removal Procedure | None | 136 Participants |
| LCS12 (Skyla, BAY86-5028) | Participants' Evaluation of Pain During IUS Removal Procedure | Mild | 96 Participants |
| LCS12 (Skyla, BAY86-5028) | Participants' Evaluation of Pain During IUS Removal Procedure | Moderate | 30 Participants |
Other Pre-specified
Participants' Evaluation of Pain During Successful IUS Insertion Procedure
Time frame: Up to 18 months
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Participants' Evaluation of Pain During Successful IUS Insertion Procedure | None | 49 Participants |
| LCS12 (Skyla, BAY86-5028) | Participants' Evaluation of Pain During Successful IUS Insertion Procedure | Mild | 125 Participants |
| LCS12 (Skyla, BAY86-5028) | Participants' Evaluation of Pain During Successful IUS Insertion Procedure | Moderate | 80 Participants |
| LCS12 (Skyla, BAY86-5028) | Participants' Evaluation of Pain During Successful IUS Insertion Procedure | Severe | 25 Participants |