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
Overview
- Phase
- Phase 3
- Intervention
- Levonorgestrel IUD (LCS, BAY86-5028)
- Conditions
- Contraception
- Sponsor
- Bayer
- Enrollment
- 567
- Locations
- 47
- Primary Endpoint
- Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
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
Intervention: Levonorgestrel IUD (LCS, BAY86-5028)
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
Intervention: Yasmin (EE30/DRSP, BAY86-5131)
Outcomes
Primary Outcomes
Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)
Time Frame: 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.
Secondary Outcomes
- Overall Satisfaction Rating by the 5-point Likert Item at 6 Months(At 6 months)
- Overall Satisfaction Rating by the 5-point Likert Item at 12 Months(At 12 months)
- User Satisfaction - Acceptability of the Administration of Study Treatment(At 12 months)
- Overall Satisfaction Rating by the 5-point Likert Item at 18 Months(At 18 months)
- Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)(At 18 months/EOS)
- Overall Satisfaction Rate at 12 Months (LOCF)(At 12 months)
- User Satisfaction - Satisfaction With Menstrual Bleeding Absence(At 18 months/EOS)
- Overall Satisfaction Rate at 6 Months (LOCF)(At 6 months)
- User Satisfaction - Frequency of Experiencing Unexpected Bleeding(At 18 months/EOS)
- EVAPIL-R Scores at 12 Months - Composite Score(At 12 months)
- User Satisfaction - Choices Upon Completion of the Study(At 18 months/EOS)
- User Satisfaction - Satisfaction With Menstrual Bleeding Pattern(At 18 months/EOS)
- User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment(At 18 months/EOS)
- User Satisfaction - Rating of Usual Menstrual Pain Intensity(At 18 months/EOS)
- User Satisfaction - Amount of Menstrual Bleeding(At 18 months/EOS)
- EVAPIL-R Scores at 6 Months(At 6 months)
- EVAPIL-R Scores at 18 Months/EOS(At 18 months/EOS)
- Cumulative Drop-out Rate(Up to 6, 12, 18, 24 and 36 months)
- EVAPIL-R Scores at Screening - Composite Score(At screening)
- EVAPIL-R Scores at Screening - Bother Score(At screening)
- EVAPIL-R Scores at 12 Months - Bother Score(At 12 months)
- Pearl Index (PI)(Up to 18, 24, 36 months)
- Compliance Rate for Yasmin Pill Intake(Up to 18 months)