check_circleStudy Completed

Contraception

Bayer Identifier:

13362

ClinicalTrials.gov Identifier:

NCT01254292

EudraCT Number:

2010-020181-21

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.

Key Participants Requirements

Sex

Female

Age

18 - 29 Years
  • - 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.
  • - 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
567
Trial Dates
January 2011 - May 2014
Phase
Phase 3
Could I Receive a placebo
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 GentGENT, 9000, Belgium
Completed
Gynaecologen Noord AntwerpenEKEREN, 2180, Belgium
Completed
Hôpital Erasme/Erasmus ZiekenhuisBRUXELLES-BRUSSEL, 1070, Belgium
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
Dr. Philip LoquetAntwerpen, 2018, Belgium
Completed
Ordination Dr. Schmidl-AmannSt. Pölten, 3100, Austria
Completed
Dr. Walter PaulikZeltweg, 8740, Austria
Completed
Landeskrankenhaus BregenzBregenz, 6900, Austria
Completed
Dr. Wolfgang BartlWien, 1200, Austria
Completed
Ordination Dr. TrostVoitsberg, 8570, Austria
Completed
Ordination Dr. SatorTulln, 3430, Austria
Completed
Dr. Bernhard SvejdaKlagenfurt, 9020, Austria
Completed
Praxis Dr. Hannes KahrGraz, 8010, Austria
Completed
Dr. Max StiglbauerWiener Neustadt, 2700, Austria
Completed
Dr. Brigitte WiesenthalWien, 1070, Austria
Completed
Visions Clinical ResearchBoynton Beach, 33472-2952, United States
Completed
Genesis Center for Clinical ResearchSan Diego, 92103, United States
Completed
Visions Clinical Research - TucsonTucson, 85712, United States
Completed
Clinical Research of Philadelphia, LLCPhiladelphia, 19114, United States
Completed
Grossmont Center for Clinical ResearchLa Mesa, 91942, United States
Completed
Women's Clinic of Lincoln, PCLincoln, 68510, United States
Completed
Seattle Women's: Health, Research, GynecologySeattle, 98105, United States
Completed
Evangelisches Krankenhaus Köln Weyertal gGmbHKöln, 50931, Germany
Completed
Praxis Hr. Dr. A. SoderEttlingen, 76275, Germany
Completed
Praxis Hr. Dr. K. BuehlingHamburg, 22587, Germany
Completed
Boston Medical CenterBoston, 02118, United States
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
Advanced Research AssociatesCorpus Christi, 78414, United States
Completed
Praxis Hr. Dr. K. PetersHamburg, 22159, Germany
Completed
Praxis Hr. Dr. K. GrevenHannover, 30459, Germany
Completed
Praxis Fr. C. BurgkhardtLeipzig, 04299, Germany
Completed
Frauenarztpraxis Dr. Robert HantschelDippoldiswalde, 01744, Germany
Completed
Frauenarztpraxis Dr. Bernd PittnerLeipzig, 04207, Germany
Completed
Praxis Hr. H. ThelenJessen, 06917, Germany
Completed
Praxis Hr. Dr. E. Goeckeler-LeopoldGeseke, 59590, Germany
Terminated
Institute of Obsteric & Gyn.St. Petersburg, 199034, Russia
Terminated
City Perinatal CenterNovosibirsk, 630089, Russia
Terminated
Instit. of Motherhood & Childhood care n.a. GorodkovIvanovo, 153045, Russia
Terminated
Scientific Center of family health & human reprod. problemsIrkutsk, 664003, Russia
Terminated
Altai State Medical UniversityBarnaul, 656038, Russia
Completed
Oregon Health and Science UniversityPortland, 97239-3011, United States
Completed
Columbus Center for Women's Health ResearchColumbus, 43213, United States
Completed
Praxis Hr. Dr. D. RautenbergHamburg, 21073, Germany
Completed
Praxis Fr. Dr. A. BrauneMagdeburg, 39104, Germany
Completed
Praxis f. Gynäkologie und GeburtshilfeBernburg, 06406, Germany
Completed
Frauenarztpraxis Dr. WetzelBlankenburg, 38889, Germany
Completed
Praxis Hr. Dr. U. KoppraschDresden, 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 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    At 6 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 12 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 18 months
    enhanced_encryption
    Safety Issue:
    No
  • 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/EOS
    enhanced_encryption
    Safety Issue:
    No
  • 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 months
    enhanced_encryption
    Safety Issue:
    No
  • 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 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 18 months/EOS
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 18 months/EOS
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 18 months/EOS
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 18 months/EOS
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 18 months/EOS
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 18 months/EOS
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 18 months/EOS
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 18 months/EOS
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At screening
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At screening
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 6 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 12 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 12 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 18 months/EOS
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 6, 12, 18, 24 and 36 months
    enhanced_encryption
    Safety Issue:
    No
  • 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 months
    enhanced_encryption
    Safety Issue:
    No
  • Compliance rate for Yasmin pill intake
    date_rangeTime Frame:
    Up to 18 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 6 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 12 months
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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