Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Levonorgestrel IUD · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| LCS12 (Skyla, BAY86-5028) | EXPERIMENTAL | 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 |
| EE30/DRSP (Yasmin, BAY86-5131) | ACTIVE_COMPARATOR | Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles |
| Name | Type | Description |
|---|---|---|
| Levonorgestrel IUD (LCS, BAY86-5028) | DRUG | 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. |
| Yasmin (EE30/DRSP, BAY86-5131) | DRUG | 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. |
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 ute...
Levonorgestrel IUD is used for contraception. It is an intrauterine device that releases the hormone levonorgestrel to prevent pregnancy. It is being developed by Bayer AG for this indication.
Levonorgestrel IUD is developed by Bayer AG, which trades under the ticker BAYRY. The company is conducting clinical trials to evaluate the device for contraception.
Levonorgestrel IUD is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 3 trial has been completed.
Levonorgestrel IUD has one completed Phase 3 trial, NCT01254292, titled 'LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study.' The trial enrolled 567 female participants aged 18 years and older across the United States, Austria, Belgium, Germany, and Russia.
In the clinical trial NCT01254292, Levonorgestrel IUD is referred to as LCS12. The study compares LCS12 with a combined oral contraceptive to assess user satisfaction.