Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LCS12 · 1 trial · 1 indication
The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were at risk of getting pregnant.
The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
| Arm | Type | Description |
|---|---|---|
| LCS12 | EXPERIMENTAL | Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro |
| LCS16 | EXPERIMENTAL | Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro |
| Name | Type | Description |
|---|---|---|
| LCS12 | DRUG | Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h |
| LCS16 | DRUG | Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h |
Inclusion Criteria: * Age between 18 and 35 years (inclusive), in good general health and requesting contraception. * Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use). Exclusion Criteria: * Known or suspected pregnancy or is...
LCS12 is an investigational small molecule being developed for contraception. It is a levonorgestrel contraceptive intrauterine system studied in a Phase 3 clinical trial for the prevention of pregnancy. The drug is currently in clinical development and is not approved by the FDA.
LCS12 is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. The company conducted a Phase 3 clinical trial of the drug for contraception.
LCS12 is in Phase 3 clinical development. It has completed one Phase 3 trial, NCT00528112, which evaluated the drug as a contraceptive intrauterine system. The drug remains investigational and has not received regulatory approval.
LCS12 has one completed Phase 3 clinical trial, NCT00528112, titled 'Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study.' The trial enrolled 2,885 healthy female participants aged 18 years and older across multiple countries, including the United States, Argentina, Canada, and several European nations.
LCS12 is a levonorgestrel contraceptive intrauterine system, meaning it contains the hormone levonorgestrel. The drug is delivered via an intrauterine device for contraception. The clinical trial NCT00528112 evaluated this system for its Pearl Index, a measure of contraceptive effectiveness.