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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020181-21 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCS12 (Skyla, BAY86-5028) | Experimental | 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 |
|
| EE30/DRSP (Yasmin, BAY86-5131) | Active Comparator | Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel IUD (LCS, BAY86-5028) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 18, 24, 36 months |
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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visions Clinical Research - Tucson | Tucson | Arizona | 85712 | United States | ||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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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.
The study was conducted in 42 centers across 4 countries in Austria, Belgium, Germany and United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | EE30/DRSP (Yasmin, BAY86-5131) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Comparative Phase |
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| Yasmin (EE30/DRSP, BAY86-5131) | Drug | 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. |
|
| At 6 months |
| 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. | At 12 months |
| 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. | At 18 months |
| 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. | At 18 months/EOS |
| 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. | At 6 months |
| 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. | At 12 months |
| 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. | At 18 months/EOS |
| 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. | At 18 months/EOS |
| 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. | At 18 months/EOS |
| 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. | At 18 months/EOS |
| 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. | At 18 months/EOS |
| 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. | At 18 months/EOS |
| 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. | At 18 months/EOS |
| 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. | At 18 months/EOS |
| 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. | At screening |
| 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. | At screening |
| 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. | At 6 months |
| 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. | At 12 months |
| 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. | At 12 months |
| 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. | At 18 months/EOS |
| 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. | Up to 6, 12, 18, 24 and 36 months |
| 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. | Up to 18, 24, 36 months |
| Compliance Rate for Yasmin Pill Intake | Up to 18 months |
| 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. | At 6 months |
| 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. | At 12 months |
| Investigator's Evaluation of Successful IUS Insertion Procedure | Up to 18 months |
| 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 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Grossmont Center for Clinical Research | La Mesa | California | 91942 | United States |
| La Mesa | California | 91942 | United States |
| Genesis Center for Clinical Research | San Diego | California | 92103 | United States |
| San Diego | California | 92103 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| San Diego | California | 92108 | United States |
| Visions Clinical Research | Boynton Beach | Florida | 33472-2952 | United States |
| Boynton Beach | Florida | 33472-2952 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Boston | Massachusetts | 02118 | United States |
| Women's Clinic of Lincoln, PC | Lincoln | Nebraska | 68510 | United States |
| Lincoln | Nebraska | 68510 | United States |
| Columbus Center for Women's Health Research | Columbus | Ohio | 43213 | United States |
| Columbus | Ohio | 43213 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239-3011 | United States |
| Portland | Oregon | 97239-3011 | United States |
| Clinical Research of Philadelphia, LLC | Philadelphia | Pennsylvania | 19114 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Advanced Research Associates | Corpus Christi | Texas | 78414 | United States |
| Corpus Christi | Texas | 78414 | United States |
| Seattle Women's: Health, Research, Gynecology | Seattle | Washington | 98105 | United States |
| Seattle | Washington | 98105 | United States |
| Ordination Dr. Schmidl-Amann | Sankt Pölten | Lower Austria | 3100 | Austria |
| Sankt Pölten | Lower Austria | 3100 | Austria |
| Dr. Max Stiglbauer | Wiener Neustadt | Lower Austria | 2700 | Austria |
| Wiener Neustadt | Lower Austria | 2700 | Austria |
| Ordination Dr. Trost | Voitsberg | Styria | 8570 | Austria |
| Voitsberg | Styria | 8570 | Austria |
| Landeskrankenhaus Bregenz | Bregenz | Vorarlberg | 6900 | Austria |
| Bregenz | Vorarlberg | 6900 | Austria |
| Praxis Dr. Hannes Kahr | Graz | 8010 | Austria |
| Graz | 8010 | Austria |
| Dr. Bernhard Svejda | Klagenfurt | 9020 | Austria |
| Klagenfurt | 9020 | Austria |
| Ordination Dr. Sator | Tulln | 3430 | Austria |
| Tulln | 3430 | Austria |
| Dr. Brigitte Wiesenthal | Vienna | 1070 | Austria |
| Vienna | 1070 | Austria |
| Dr. Wolfgang Bartl | Vienna | 1200 | Austria |
| Vienna | 1200 | Austria |
| Dr. Walter Paulik | Zeltweg | 8740 | Austria |
| Zeltweg | 8740 | Austria |
| Dr. Philip Loquet | Antwerp | 2018 | Belgium |
| Antwerp | 2018 | Belgium |
| Hôpital Erasme/Erasmus Ziekenhuis | Bruxelles-brussel | 1070 | Belgium |
| Bruxelles-brussel | 1070 | Belgium |
| Gynaecologen Noord Antwerpen | Ekeren | 2180 | Belgium |
| Ekeren | 2180 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| Ghent | 9000 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Leuven | 3000 | Belgium |
| Praxis Hr. Dr. A. Soder | Ettlingen | Baden-Wurttemberg | 76275 | Germany |
| Ettlingen | Baden-Wurttemberg | 76275 | Germany |
| Praxis Hr. Dr. K. Greven | Hanover | Lower Saxony | 30459 | Germany |
| Hanover | Lower Saxony | 30459 | Germany |
| Evangelisches Krankenhaus Köln Weyertal gGmbH | Cologne | North Rhine-Westphalia | 50931 | Germany |
| Cologne | North Rhine-Westphalia | 50931 | Germany |
| Praxis Hr. Dr. E. Goeckeler-Leopold | Geseke | North Rhine-Westphalia | 59590 | Germany |
| Geseke | North Rhine-Westphalia | 59590 | Germany |
| Frauenarztpraxis Dr. Robert Hantschel | Dippoldiswalde | Saxony | 01744 | Germany |
| Dippoldiswalde | Saxony | 01744 | Germany |
| Praxis Hr. Dr. U. Kopprasch | Dresden | Saxony | 01169 | Germany |
| Dresden | Saxony | 01169 | Germany |
| Frauenarztpraxis Dr. Bernd Pittner | Leipzig | Saxony | 04207 | Germany |
| Leipzig | Saxony | 04207 | Germany |
| Praxis Fr. C. Burgkhardt | Leipzig | Saxony | 04299 | Germany |
| Leipzig | Saxony | 04299 | Germany |
| Praxis f. Gynäkologie und Geburtshilfe | Bernburg | Saxony-Anhalt | 06406 | Germany |
| Bernburg | Saxony-Anhalt | 06406 | Germany |
| Frauenarztpraxis Dr. Wetzel | Blankenburg | Saxony-Anhalt | 38889 | Germany |
| Blankenburg | Saxony-Anhalt | 38889 | Germany |
| Praxis Hr. H. Thelen | Jessen | Saxony-Anhalt | 06917 | Germany |
| Jessen | Saxony-Anhalt | 06917 | Germany |
| Praxis Fr. Dr. A. Braune | Magdeburg | Saxony-Anhalt | 39104 | Germany |
| Magdeburg | Saxony-Anhalt | 39104 | Germany |
| Praxis Hr. Dr. D. Rautenberg | Hamburg | 21073 | Germany |
| Hamburg | 21073 | Germany |
| Praxis Hr. Dr. K. Peters | Hamburg | 22159 | Germany |
| Hamburg | 22159 | Germany |
| Praxis Hr. Dr. K. Buehling | Hamburg | 22587 | Germany |
| Hamburg | 22587 | Germany |
| Altai State Medical University | Barnaul | 656038 | Russia |
| Barnaul | 656038 | Russia |
| Scientific Center of family health & human reprod. problems | Irkutsk | 664003 | Russia |
| Irkutsk | 664003 | Russia |
| Instit. of Motherhood & Childhood care n.a. Gorodkov | Ivanovo | 153045 | Russia |
| Ivanovo | 153045 | Russia |
| City Perinatal Center | Novosibirsk | 630089 | Russia |
| Novosibirsk | 630089 | Russia |
| Institute of Obsteric & Gyn. | Saint Petersburg | 199034 | Russia |
| Saint Petersburg | 199034 | Russia |
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles |
| Participants Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| LCS12 Extension Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Number of births | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Full analysis set (only subjects with at least one assessment of the overall satisfaction rating) | Posted | Number | Percentage of participants | At 18 months |
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| 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. | Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months) | Posted | Number | Percentage of participants | At 6 months |
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| 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. | Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months) | Posted | Number | Percentage of participants | At 12 months |
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| 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. | Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months) | Posted | Number | Percentage of participants | At 18 months |
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| 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. | Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months/end of study) | Posted | Number | Percentage of participants | At 18 months/EOS |
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| 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. | Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months or before) | Posted | Number | Percentage of participants | At 6 months |
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| 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. | Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months) | Posted | Number | Percentage of participants | At 12 months |
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| 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. | Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study) | Posted | Number | Participants | At 18 months/EOS |
|
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| 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. | Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study) | Posted | Number | Participants | At 18 months/EOS |
|
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| 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. | Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study) | Posted | Number | Participants | At 18 months/EOS |
|
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| 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. | Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study) | Posted | Number | Participants | At 18 months/EOS |
|
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| 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. | Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study) | Posted | Number | Participants | At 18 months/EOS |
|
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| 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. | Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study) | Posted | Number | Participants | At 18 months/EOS |
|
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| 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. | Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study) | Posted | Number | Participants | At 18 months/EOS |
|
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| 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. | Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study) | Posted | Number | Participants | At 18 months/EOS |
|
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| 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. | Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the composite score could be calculated) | Posted | Mean | Standard Deviation | Scores on a scale | At screening |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the bother score could be calculated) | Posted | Mean | Standard Deviation | Scores on a scale | At screening |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 6 months where the scores could be calculated) | Posted | Mean | Standard Deviation | Scores on a scale | At 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the bother score could be calculated) | Posted | Mean | Standard Deviation | Scores on a scale | At 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the composite score could be calculated) | Posted | Mean | Standard Deviation | Scores on a scale | At 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 18 months/end of study where the scores could be calculated) | Posted | Mean | Standard Deviation | Scores on a scale | At 18 months/EOS |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set | Posted | Number | Percentage of participants | Up to 6, 12, 18, 24 and 36 months |
|
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| 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. | Full analysis set | Posted | Mean | 95% Confidence Interval | Pregnancies per 100 women years | Up to 18, 24, 36 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Compliance Rate for Yasmin Pill Intake | Full analysis set | Posted | Number | Percentage of participants | Up to 18 months |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set | Posted | Number | Participants | Up to 18, 24, 36 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Investigator's Evaluation of Successful IUS Insertion Procedure | Full analysis set | Posted | Number | Participants | Up to 18 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Participants' Evaluation of Pain During Successful IUS Insertion Procedure | Full analysis set | Posted | Number | Participants | Up to 18 months |
|
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| Other Pre-specified | Investigator's Evaluation of IUS Removal Procedure | Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS) | Posted | Number | Participants | Up to 36 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Participants' Evaluation of Pain During IUS Removal Procedure | Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS) | Posted | Number | Participants | Up to 36 months |
|
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| 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. | Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 6 months) | Posted | Number | Participants | At 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 12 months) | Posted | Number | Participants | At 12 months |
|
|
From start of treatment until 36 months/EOS visit.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 22 | 279 | 215 | 279 | ||
| EG001 | 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 | 5 | 281 | 148 | 281 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basedow's disease | Endocrine disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Femoral hernia | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Nose deformity | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Non-systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (15.1) | Non-systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (15.1) | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Basedow's disease | Endocrine disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Femoral hernia | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nose deformity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Borderline ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Non-systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (17.0) | Non-systematic Assessment |
| |
| Breast fibrosis | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Breast prosthesis implantation | Surgical and medical procedures | MedDRA (17.0) | Non-systematic Assessment |
| |
| Myomectomy | Surgical and medical procedures | MedDRA (17.0) | Non-systematic Assessment |
| |
| Mammoplasty | Surgical and medical procedures | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vulvitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vulvovaginitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vaginitis bacterial | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vulvovaginitis streptococcal | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
| |
| Smear cervix abnormal | Investigations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Human papilloma virus test positive | Investigations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Coital bleeding | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Wisdom teeth removal | Surgical and medical procedures | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vaginitis gardnerella | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vulvitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vulvovaginitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vulvovaginitis streptococcal | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vaginitis chlamydial | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Smear cervix abnormal | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Human papilloma virus test positive | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chlamydia test positive | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dyspareunia | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Coital bleeding | Reproductive system and breast disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Wisdom teeth removal | Surgical and medical procedures | MedDRA (17.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer AG | clinical-trials-contact@bayer.com |
| ID | Term |
|---|---|
| C534342 | drospirenone and ethinyl estradiol combination |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Other unknown |
|
| Pregnancy |
|
| Lost to Follow-up |
|
| Male |
|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| single proportion |
| 81.9 |
| 2-Sided |
| 95 |
| 76.7 |
| 86.4 |
Clopper Pearson Confidence Interval |
| Superiority or Other |
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Participants |
|
|
|
| Categories |
|---|
| Missing |
| |||||
| Compliance <=75% |
| |||||
| Compliance >75% |
|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Easy |
| |||||
| Slightly difficult |
| |||||
| Very difficult |
|
| Title | Denominators | Categories |
|---|
| None |
| |||||
| Mild |
| |||||
| Moderate |
| |||||
| Severe |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Easy |
| |||||
| Slightly difficult |
| |||||
| Very difficult |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| None |
| |||||
| Mild |
| |||||
| Moderate |
| |||||
| Severe |
|
|
|
|
|