check_circleStudy Completed
Contraception
Bayer Identifier:
13362
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
LCS12 vs Combined Oral Contraceptive (COC) user satisfaction study
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.
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.
Key Participants Requirements
Sex
FemaleAge
18 - 29 YearsTrial summary
Enrollment Goal
567Trial Dates
January 2011 - May 2014Phase
Phase 3Could I Receive a placebo
NoProducts
Skyla (Levonorgestrel, BAY86-5028)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | GENT, 9000, Belgium | |
Completed | EKEREN, 2180, Belgium | |
Completed | BRUXELLES-BRUSSEL, 1070, Belgium | |
Completed | LEUVEN, 3000, Belgium | |
Completed | Antwerpen, 2018, Belgium | |
Completed | St. Pölten, 3100, Austria | |
Completed | Zeltweg, 8740, Austria | |
Completed | Bregenz, 6900, Austria | |
Completed | Wien, 1200, Austria | |
Completed | Voitsberg, 8570, Austria | |
Completed | Tulln, 3430, Austria | |
Completed | Klagenfurt, 9020, Austria | |
Completed | Graz, 8010, Austria | |
Completed | Wiener Neustadt, 2700, Austria | |
Completed | Wien, 1070, Austria | |
Completed | Boynton Beach, 33472-2952, United States | |
Completed | San Diego, 92103, United States | |
Completed | Tucson, 85712, United States | |
Completed | Philadelphia, 19114, United States | |
Completed | La Mesa, 91942, United States | |
Completed | Lincoln, 68510, United States | |
Completed | Seattle, 98105, United States | |
Completed | Köln, 50931, Germany | |
Completed | Ettlingen, 76275, Germany | |
Completed | Hamburg, 22587, Germany | |
Completed | Boston, 02118, United States | |
Completed | San Diego, 92108, United States | |
Completed | Corpus Christi, 78414, United States | |
Completed | Hamburg, 22159, Germany | |
Completed | Hannover, 30459, Germany | |
Completed | Leipzig, 04299, Germany | |
Completed | Dippoldiswalde, 01744, Germany | |
Completed | Leipzig, 04207, Germany | |
Completed | Jessen, 06917, Germany | |
Completed | Geseke, 59590, Germany | |
Terminated | St. Petersburg, 199034, Russia | |
Terminated | Novosibirsk, 630089, Russia | |
Terminated | Ivanovo, 153045, Russia | |
Terminated | Irkutsk, 664003, Russia | |
Terminated | Barnaul, 656038, Russia | |
Completed | Portland, 97239-3011, United States | |
Completed | Columbus, 43213, United States | |
Completed | Hamburg, 21073, Germany | |
Completed | Magdeburg, 39104, Germany | |
Completed | Bernburg, 06406, Germany | |
Completed | Blankenburg, 38889, Germany | |
Completed | Dresden, 01169, Germany | |
Completed | UZ Gent | GENT, 9000, Belgium |
Completed | Gynaecologen Noord Antwerpen | EKEREN, 2180, Belgium |
Completed | Hôpital Erasme/Erasmus Ziekenhuis | BRUXELLES-BRUSSEL, 1070, Belgium |
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | Dr. Philip Loquet | Antwerpen, 2018, Belgium |
Completed | Ordination Dr. Schmidl-Amann | St. Pölten, 3100, Austria |
Completed | Dr. Walter Paulik | Zeltweg, 8740, Austria |
Completed | Landeskrankenhaus Bregenz | Bregenz, 6900, Austria |
Completed | Dr. Wolfgang Bartl | Wien, 1200, Austria |
Completed | Ordination Dr. Trost | Voitsberg, 8570, Austria |
Completed | Ordination Dr. Sator | Tulln, 3430, Austria |
Completed | Dr. Bernhard Svejda | Klagenfurt, 9020, Austria |
Completed | Praxis Dr. Hannes Kahr | Graz, 8010, Austria |
Completed | Dr. Max Stiglbauer | Wiener Neustadt, 2700, Austria |
Completed | Dr. Brigitte Wiesenthal | Wien, 1070, Austria |
Completed | Visions Clinical Research | Boynton Beach, 33472-2952, United States |
Completed | Genesis Center for Clinical Research | San Diego, 92103, United States |
Completed | Visions Clinical Research - Tucson | Tucson, 85712, United States |
Completed | Clinical Research of Philadelphia, LLC | Philadelphia, 19114, United States |
Completed | Grossmont Center for Clinical Research | La Mesa, 91942, United States |
Completed | Women's Clinic of Lincoln, PC | Lincoln, 68510, United States |
Completed | Seattle Women's: Health, Research, Gynecology | Seattle, 98105, United States |
Completed | Evangelisches Krankenhaus Köln Weyertal gGmbH | Köln, 50931, Germany |
Completed | Praxis Hr. Dr. A. Soder | Ettlingen, 76275, Germany |
Completed | Praxis Hr. Dr. K. Buehling | Hamburg, 22587, Germany |
Completed | Boston Medical Center | Boston, 02118, United States |
Completed | Medical Center for Clinical Research | San Diego, 92108, United States |
Completed | Advanced Research Associates | Corpus Christi, 78414, United States |
Completed | Praxis Hr. Dr. K. Peters | Hamburg, 22159, Germany |
Completed | Praxis Hr. Dr. K. Greven | Hannover, 30459, Germany |
Completed | Praxis Fr. C. Burgkhardt | Leipzig, 04299, Germany |
Completed | Frauenarztpraxis Dr. Robert Hantschel | Dippoldiswalde, 01744, Germany |
Completed | Frauenarztpraxis Dr. Bernd Pittner | Leipzig, 04207, Germany |
Completed | Praxis Hr. H. Thelen | Jessen, 06917, Germany |
Completed | Praxis Hr. Dr. E. Goeckeler-Leopold | Geseke, 59590, Germany |
Terminated | Institute of Obsteric & Gyn. | St. Petersburg, 199034, Russia |
Terminated | City Perinatal Center | Novosibirsk, 630089, Russia |
Terminated | Instit. of Motherhood & Childhood care n.a. Gorodkov | Ivanovo, 153045, Russia |
Terminated | Scientific Center of family health & human reprod. problems | Irkutsk, 664003, Russia |
Terminated | Altai State Medical University | Barnaul, 656038, Russia |
Completed | Oregon Health and Science University | Portland, 97239-3011, United States |
Completed | Columbus Center for Women's Health Research | Columbus, 43213, United States |
Completed | Praxis Hr. Dr. D. Rautenberg | Hamburg, 21073, Germany |
Completed | Praxis Fr. Dr. A. Braune | Magdeburg, 39104, Germany |
Completed | Praxis f. Gynäkologie und Geburtshilfe | Bernburg, 06406, Germany |
Completed | Frauenarztpraxis Dr. Wetzel | Blankenburg, 38889, Germany |
Completed | Praxis Hr. Dr. U. Kopprasch | Dresden, 01169, Germany |
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.date_rangeTime Frame:At 18 monthsenhanced_encryptionNoSafety Issue:
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.date_rangeTime Frame:At 6 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 12 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 18 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 18 months/EOSenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 6 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 12 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 18 months/EOSenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 18 months/EOSenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 18 months/EOSenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 18 months/EOSenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 18 months/EOSenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 18 months/EOSenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 18 months/EOSenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 18 months/EOSenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At screeningenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At screeningenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 6 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 12 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 12 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 18 months/EOSenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 6, 12, 18, 24 and 36 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to 18, 24, 36 monthsenhanced_encryptionNoSafety Issue:
- Compliance rate for Yasmin pill intakedate_rangeTime Frame:Up to 18 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 6 monthsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:At 12 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2Additional Information
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