LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study
Condition: Contraception
Intervention: Levonorgestrel IUD (LCS, BAY86-5028); Yasmin (EE30/DRSP, BAY86-5131)
Intervention description: LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 18 months with optional extension to 36 months for subjects in this group only.; Combined oral contraceptive (COC; Yasmin; 0.03 mg ethinyl estradiol and 3 mg drospirenone); Subjects will start taking COC at / on the day of visit 2 and continue taking one pill / day without any breaks for the entire study duration of 18 months.
Intervention MeSH terms: Levonorgestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 567.0
Sex: Female
Minimum age: 18 Years
Maximum age: 29 Years
Healthy volunteers: No

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.
    

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.