LCS16 vs. COC User Satisfaction and Tolerability Study

Study Overview
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Brief Summary
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To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age [inclusive]), using LCS16 compared to a COC over a period of 12 months.

Official Title
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Multi-center, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 16 μg LNG/Day Initial in Vitro Release Rate (LCS16) in Comparison to a Combined Oral Contraceptive (COC) Containing 30 μg Ethinyl Estradiol and 3 mg Drospirenone (Yarina®) in Young Nulliparous and Parous Women (18 - 29 Years) Over 12 Months of Use (With an Option for Extended Use of LCS16 for up to 5 Years)

Conditions
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Contraception

Intervention / Treatment
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* Drug: Levonorgestrel (Kyleena, BAY86-5028)
* Drug: Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject has signed and dated the Informed Consent Form (ICF). The subject is healthy when requesting contraception. The subject is between 18 - 29 years of age (inclusive) at the time of signing the ICF. The subject has normal or clinically insignificant cervical smear for oncocytology (i.e. Pap test) not requiring further follow up (a cervical smear has to be taken at the Screening Visit [Visit 1] or a normal result has to have been documented within the previous 6 months). The subject has a history of regular (i.e., endogenous cyclicity without hormonal contraceptive use) cyclic menstrual periods (length of cycle 21 - 35 days), as confirmed by the subject. The 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 postpartum or since abortion before the Screening Visit) Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit. Chronic, daily use of drugs that may increase serum potassium levels. Undiagnosed abnormal genital bleeding. Acute cervicitis or vaginitis (until successfully treated). Lower urinary tract infection (until successfully treated). Acute or recurrent pelvic inflammatory disease or conditions associated with increased risk for pelvic infections. Congenital or acquired uterine anomaly including fibroids, in the opinion of the investigator, which would interfere with insertion and/or retention of the intrauterine system (i.e., if they distort the uterine cavity). Cervical neoplasia, uterine or cervical malignancy, or sex hormone-dependent tumors. History of migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>LCS16 (Low-dose LNG IUS) | Drug: Levonorgestrel (Kyleena, BAY86-5028)<br>* Low-dose LNG IUS with an initial in vitro release rate of 16 μg LNG/day, used continuously. The total LNG content in LCS16 is 19.5 mg. Administered intrauterine, for 12 months with an option for extended use for up to 5 years<br>|
| Active Comparator: Reference<br>COC (Yarina) | Drug: Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)<br>* COC tablet containing 30 μg ethinyl estradiol and 3 mg drospirenone (taken on cycle days 1-21, inclusive, followed by a 7-day tablet-free week) for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction rate | 5-point Likert item Very satisfied Satisfied Neither satisfied nor dissatisfied Dissatisfied Very dissatisfied | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | at 1, 6 and 12 months for all subjects during the comparative part of the study. at the end of Year 2, Year 3, Year 4 and Year 5 only for subjects, who elect to enter the LCS16 extension phase. | Up to 5 years | 
| Discontinuation rates | at 1, 6 and 12 months for all subjects during the comparative part of the study. at the end of Year 2, Year 3, Year 4 and Year 5 only for subjects, who elect to enter the LCS16 extension phase. | Up to 5 years | 
| Bleeding pattern | Only during the comparative part of the study | Up to 12 months | 
| User satisfaction and bleeding questionnaire | At 6 and 12 months after the start of study treatment (or at early termination for those subjects discontinuing the study before completion of the 12 months) for all subjects during the comparative part of the study. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine, Birth control