LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

• Overall Satisfaction Rating in LCS12 and COC users [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: No ]
• Pregnancy rate, as determined by Pearl index [ Time Frame: 18 months ] [ Designated as safety issue: No ]
• Tolerability, as assessed by change of Modified EVAPIL Scale score from baseline [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]
• Discontinuation rates [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]
• LCS12 expulsion rates [ Time Frame: 18 months and 24 and 36 months for subjects in the LCS12 extension phase ] [ Designated as safety issue: Yes ]
• Ease of LCS12 insertion and removal [ Time Frame: At insertion (visit 2) and at 18 months or 36 months (end of study) for subjects in LCS12 extension phase ] [ Designated as safety issue: Yes ]
• Pain on LCS12 insertion and removal [ Time Frame: At insertion (visit 2) and 18 months or 36 months (end of study) for subjects in LCS12 extension phase ] [ Designated as safety issue: Yes ]
• Treatment-emergent adverse events / serious adverse events [ Time Frame: 18, 24 and 36 months for subjects in LCS12 extension phase ] [ Designated as safety issue: Yes ]

• Overall Satisfaction Rating in LCS12 and COC users [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: No ]
• Pregnancy rate, as determined by Pearl index [ Time Frame: 18 months ] [ Designated as safety issue: No ]
• Tolerability, as assessed by change of Modified EVAPIL Scale score from baseline [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]
• Discontinuation rates [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]
• LCS12 expulsion rates [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
• Ease of LCS12 insertion and removal [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
• Pain on LCS12 insertion and removal [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
• Treatment-emergent adverse events / serious adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

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.

• Drug: Levonorgestrel IUD (LCS, BAY86-5028)
  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.
• Drug: Yasmin (EE30/DRSP, BAY86-5131)
  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.

• Experimental: Arm 1
  Intervention: Drug: Levonorgestrel IUD (LCS, BAY86-5028)
• Active Comparator: Arm 2
  Intervention: Drug: Yasmin (EE30/DRSP, BAY86-5131)

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.