Trial Condition(s):
Contraception
LCS12 vs Combined Oral Contraceptive (COC) user satisfaction study
Bayer Identifier:
13362
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site GENT, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site EKEREN, Belgium, 2180 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES-BRUSSEL, Belgium, 1070 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Antwerpen, Belgium, 2018 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Pölten, Austria, 3100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zeltweg, Austria, 8740 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bregenz, Austria, 6900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Voitsberg, Austria, 8570 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tulln, Austria, 3430 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Klagenfurt, Austria, 9020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wiener Neustadt, Austria, 2700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1070 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boynton Beach, United States, 33472-2952 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tucson, United States, 85712 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site La Mesa, United States, 91942 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lincoln, United States, 68510 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50931 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ettlingen, Germany, 76275 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 22587 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02118 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92108 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Corpus Christi, United States, 78414 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 22159 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30459 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04299 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dippoldiswalde, Germany, 01744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jessen, Germany, 06917 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Geseke, Germany, 59590 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 199034 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Novosibirsk, Russia, 630089 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ivanovo, Russia, 153045 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Irkutsk, Russia, 664003 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barnaul, Russia, 656038 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portland, United States, 97239-3011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43213 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 21073 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Magdeburg, Germany, 39104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bernburg, Germany, 06406 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Blankenburg, Germany, 38889 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01169 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Gent GENT, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gynaecologen Noord Antwerpen EKEREN, Belgium, 2180 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Erasme/Erasmus Ziekenhuis BRUXELLES-BRUSSEL, Belgium, 1070 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Philip Loquet Antwerpen, Belgium, 2018 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ordination Dr. Schmidl-Amann St. Pölten, Austria, 3100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Walter Paulik Zeltweg, Austria, 8740 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Landeskrankenhaus Bregenz Bregenz, Austria, 6900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Wolfgang Bartl Wien, Austria, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ordination Dr. Trost Voitsberg, Austria, 8570 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ordination Dr. Sator Tulln, Austria, 3430 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Bernhard Svejda Klagenfurt, Austria, 9020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. Hannes Kahr Graz, Austria, 8010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Max Stiglbauer Wiener Neustadt, Austria, 2700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Brigitte Wiesenthal Wien, Austria, 1070 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Visions Clinical Research Boynton Beach, United States, 33472-2952 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Genesis Center for Clinical Research San Diego, United States, 92103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Visions Clinical Research - Tucson Tucson, United States, 85712 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research of Philadelphia, LLC Philadelphia, United States, 19114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Grossmont Center for Clinical Research La Mesa, United States, 91942 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Clinic of Lincoln, PC Lincoln, United States, 68510 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seattle Women's: Health, Research, Gynecology Seattle, United States, 98105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Evangelisches Krankenhaus Köln Weyertal gGmbH Köln, Germany, 50931 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. A. Soder Ettlingen, Germany, 76275 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. K. Buehling Hamburg, Germany, 22587 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Boston Medical Center Boston, United States, 02118 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advanced Research Associates Corpus Christi, United States, 78414 | Status Completed | Contact Us: E-mail: clinical-trials-cont[email protected] Phone: Not Available |
Locations Praxis Hr. Dr. K. Peters Hamburg, Germany, 22159 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. K. Greven Hannover, Germany, 30459 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. C. Burgkhardt Leipzig, Germany, 04299 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. Robert Hantschel Dippoldiswalde, Germany, 01744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. Bernd Pittner Leipzig, Germany, 04207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. H. Thelen Jessen, Germany, 06917 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. E. Goeckeler-Leopold Geseke, Germany, 59590 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institute of Obsteric & Gyn. St. Petersburg, Russia, 199034 | Status Terminated | Contact Us: E-mail: clinical-trials[email protected] Phone: Not Available |
Locations City Perinatal Center Novosibirsk, Russia, 630089 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instit. of Motherhood & Childhood care n.a. Gorodkov Ivanovo, Russia, 153045 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scientific Center of family health & human reprod. problems Irkutsk, Russia, 664003 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Altai State Medical University Barnaul, Russia, 656038 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oregon Health and Science University Portland, United States, 97239-3011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Columbus Center for Women's Health Research Columbus, United States, 43213 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. D. Rautenberg Hamburg, Germany, 21073 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. A. Braune Magdeburg, Germany, 39104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis f. Gynäkologie und Geburtshilfe Bernburg, Germany, 06406 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Frauenarztpraxis Dr. Wetzel Blankenburg, Germany, 38889 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. U. Kopprasch Dresden, Germany, 01169 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Multicenter, randomized, open-label, parallel-group study to evaluate user satisfaction with and tolerability of the low-dose levonorgestrel (LNG) intrauterine delivery system (IUS) with 12 µg LNG/day initial in vitro release rate (LCS12) in comparison to a combined oral contraceptive containing 30 µg ethinyl estradiol and 3 mg drospirenone (Yasmin®) in young women (18-29 years) over 18 months of use
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- 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.Timeframe: At 18 months
Secondary Outcome
- Overall satisfaction rating by the 5-point Likert item at 6 monthsSatisfaction 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.Timeframe: At 6 months
- Overall satisfaction rating by the 5-point Likert item at 12 monthsSatisfaction 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.Timeframe: At 12 months
- Overall satisfaction rating by the 5-point Likert item at 18 monthsSatisfaction 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.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: At 12 months
- User satisfaction – acceptability of the administration of study treatmentThe 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.Timeframe: At 18 months/EOS
- User satisfaction – choices upon completion of the studyThe 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.Timeframe: At 18 months/EOS
- User satisfaction – amount of menstrual bleedingThe 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.Timeframe: At 18 months/EOS
- User satisfaction – satisfaction with menstrual bleeding patternThe 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.Timeframe: At 18 months/EOS
- User satisfaction – frequency of experiencing unexpected bleedingThe 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.Timeframe: At 18 months/EOS
- User satisfaction – satisfaction with menstrual bleeding absenceThe 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.Timeframe: At 18 months/EOS
- User satisfaction – comparison of menstrual pain intensity between now and before treatmentThe 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.Timeframe: At 18 months/EOS
- User satisfaction – rating of usual menstrual pain intensityThe 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.Timeframe: At 18 months/EOS
- EVAPIL-R scores at screening - Composite scoreThe 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.Timeframe: At screening
- EVAPIL-R scores at screening - Bother scoreThe 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.Timeframe: At screening
- EVAPIL-R scores at 6 monthsThe 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.Timeframe: At 6 months
- EVAPIL-R scores at 12 months - Bother scoreThe 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.Timeframe: At 12 months
- EVAPIL-R scores at 12 months - Composite scoreThe 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.Timeframe: At 12 months
- EVAPIL-R scores at 18 months/EOSThe 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.Timeframe: At 18 months/EOS
- Cumulative Drop-out rateThe 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.Timeframe: 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.Timeframe: Up to 18, 24, 36 months
- Compliance rate for Yasmin pill intakeTimeframe: Up to 18 months
- User Satisfaction – Acceptability of the Administration of Study TreatmentThe 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.Timeframe: At 6 months
- User Satisfaction – Acceptability of the Administration of Study TreatmentThe 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.Timeframe: At 12 months
Additional Information
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