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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 an intrauterine device being developed for contraception. It is an investigational long-acting reversible contraceptive option studied in a Phase 3 trial comparing user satisfaction against combined oral contraceptives in adult women.
Levonorgestrel IUD works by releasing levonorgestrel, which acts as an agonist at the progesterone receptor (PGR). This target engagement supports its contraceptive effect as a long-acting intrauterine method.
Levonorgestrel IUD is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical program for this contraceptive candidate.
Levonorgestrel IUD is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA for contraception. The Phase 3 program includes one completed trial.
Levonorgestrel IUD has been studied in one completed Phase 3 trial, NCT01254292, titled LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study. It enrolled 567 women aged 18 and older across the United States, Austria, Belgium, Germany, and Russia.
Yes, Levonorgestrel IUD is also known as LCS and BAY86-5028. These alternative names refer to the same Bayer AG contraceptive candidate, so searches for LCS or BAY86-5028 lead to the same product.