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LCS12 vs Combined Oral Contraceptive (COC) user satisfaction study
 
 
 
Trial ID: 13362
 
 
 
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.
 
 
 
Official Title: 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
 
 
 
Product: Skyla (Levonorgestrel, BAY86-5028)
 
 
 
Indication/Disease: Contraception
 
 
 
Trial Status: Completed
Trial Start Date: 2011-01-06
Trial End Date: 2014-05-28 (Actual)
 
 
 
Trial Phase: Phase 3
 
 
 
Trial Design:
Trial Type: Interventional
Intervention: Drug
Trial Purpose: Prevention
Trial Endpoint: Safety/Efficacy Study
Allocation: Randomized
Blinding: Open Label
Assignment: Parallel Assignment
Trial Arms: 2
Participants: 567
 
 
 
Primary Outcome:
  • Overall satisfaction rate at 18 months (Last Observation Carried Forward, LOCF)
    Timeframe: At 18 months
 
 
 
Secondary Outcome:
  • User Satisfaction – Acceptability of the Administration of Study Treatment
    Timeframe: At 6 months
  • Compliance rate for Yasmin pill intake
    Timeframe: Up to 18 months
  • Pearl index (PI)
    Timeframe: Up to 18, 24, 36 months
  • Cumulative Drop-out rate
    Timeframe: Up to 6, 12, 18, 24 and 36 months
  • EVAPIL-R scores at 12 months - Composite score
    Timeframe: At 12 months
  • EVAPIL-R scores at 18 months/EOS
    Timeframe: At 18 months/EOS
  • EVAPIL-R scores at 12 months - Bother score
    Timeframe: At 12 months
  • EVAPIL-R scores at screening - Bother score
    Timeframe: At screening
  • EVAPIL-R scores at 6 months
    Timeframe: At 6 months
  • EVAPIL-R scores at screening - Composite score
    Timeframe: At screening
  • User satisfaction – comparison of menstrual pain intensity between now and before treatment
    Timeframe: At 18 months/EOS
  • User satisfaction – rating of usual menstrual pain intensity
    Timeframe: At 18 months/EOS
  • User satisfaction – satisfaction with menstrual bleeding absence
    Timeframe: At 18 months/EOS
  • User satisfaction – frequency of experiencing unexpected bleeding
    Timeframe: At 18 months/EOS
  • User satisfaction – satisfaction with menstrual bleeding pattern
    Timeframe: At 18 months/EOS
  • User satisfaction – choices upon completion of the study
    Timeframe: At 18 months/EOS
  • User satisfaction – amount of menstrual bleeding
    Timeframe: At 18 months/EOS
  • User satisfaction – acceptability of the administration of study treatment
    Timeframe: At 18 months/EOS
  • Overall satisfaction rate at 12 months (LOCF)
    Timeframe: At 12 months
  • Overall satisfaction rate at 6 months (LOCF)
    Timeframe: At 6 months
  • Overall satisfaction rating by the 5-point Likert item at end of study (EOS)
    Timeframe: At 18 months/EOS
  • Overall satisfaction rating by the 5-point Likert item at 18 months
    Timeframe: At 18 months
  • Overall satisfaction rating by the 5-point Likert item at 12 months
    Timeframe: At 12 months
  • Overall satisfaction rating by the 5-point Likert item at 6 months
    Timeframe: At 6 months
  • User Satisfaction – Acceptability of the Administration of Study Treatment
    Timeframe: At 12 months
 
 
 
Eligibility Criteria:
Minimum Age: 18 Years
Maximum Age: 29 Years
Gender: Female
Healthy Volunteers: No

Inclusion Criteria:
  • Subject has signed and dated the Informed Consent Form (ICF).
  • The subject is generally healthy, requesting contraception, and is between 18 and 29 years of age (inclusive) at Screening.
  • In the opinion of the investigator, the subject is
    • in good health;
    • without uterine conditions that would preempt insertion of LCS12;
    • without conditions/history that would contraindicate the use of oral contraceptives.
  • Subject has normal or clinically insignificant cervical smear (ie, one that does not require further follow up). A cervical smear must be taken at the Screening Visit or a documented normal result has to have been obtained within 6 months of Screening. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) deoxyribonucleic acid (DNA) test that, according to the standards of the local laboratory, is negative for high-risk HPV.
  • As determined by subject’s history, subject has regular (ie, endogenous cyclicity without hormonal contraceptive use) menstrual cycles (length of cycle 21-35 days).
  • Subject is willing and able to attend the scheduled study visits and to comply with the study procedures.

Exclusion Criteria:
  • Pregnancy or current lactation (less than 6 weeks since vaginal or Cesarean delivery or abortion). Note: Postpartum LCS12 insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, the investigator should consider waiting until 12 weeks postpartum.
  • Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit (Visit 1)
  • Chronic, daily use of drugs that may increase serum potassium levels, such as nonsteroidal anti-inflammatory drugs (NSAIDs, eg. ibuprofen and naproxen), potassium-sparing diuretics (eg. spironolactone), potassium supplementation, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, aldosterone antagonists, and heparin.
  • Abnormal uterine bleeding of unknown origin/undiagnosed abnormal genital bleeding
  • Any genital infection (until successfully treated)
  • Abnormal cervical smear result (see inclusion criteria)
  • Acute, current or history of recurrent pelvic inflammatory disease
  • Congenital or acquired uterine anomaly or any distortion of the uterine cavity (eg, by fibroids) that, in the opinion of the investigator, would cause problems during insertion, retention, or removal of LCS12.
 
 
 
Sponsor: Bayer
 
 
 
Countries:
RussiaTerminated
GermanyCompleted
United StatesCompleted
AustriaCompleted
BelgiumCompleted
 
 
 
Results Synopsis: PDF File
 
 
 
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