LCS16 vs. COC User Satisfaction and Tolerability Study

Phase 3

Completed

Interventions: Drug: Levonorgestrel (Kyleena, BAY86-5028)
Drug: Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Test	Levonorgestrel (Kyleena, BAY86-5028)	LCS16 (Low-dose LNG IUS)
Reference	Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)	COC (Yarina)

Primary Outcome Measures

Name	Time	Method
Overall satisfaction rate	12 months	5-point Likert item 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	Up to 5 years	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.
Bleeding pattern	Up to 12 months	Only during the comparative part of the study
User satisfaction and bleeding questionnaire	Up to 12 months	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.
Discontinuation rates	Up to 5 years	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.

Locations (9): Scientific Center of family health & human reprod. problems
🇷🇺
Irkutsk, Russian Federation
Altai State Medical University
🇷🇺
Barnaul, Russian Federation
Medical Center "Avicenna"
🇷🇺
Novosibirsk, Russian Federation
LLC Reafan
🇷🇺
Novosibirsk, Russian Federation
City Clinical Hospital #13 Moscow
🇷🇺
Moscow, Russian Federation
Krasnoyarsk State Medical University
🇷🇺
Krasnoyarsk, Russian Federation
Smolensk State Medical University
🇷🇺
Smolensk, Russian Federation
Regional perinatal center
🇷🇺
Yaroslavl, Russian Federation
LLC Medical center PRIME ROSE
🇷🇺
St. Petersburg, Russian Federation