Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Levonorgestrel IUS · 4 trials · 2 indications
The Pearl Index (PI) is defined as the number of pregnancies per 100 women years. The 3-year PI (Years 6 to 8) was obtained by dividing the number of pregnancies the occurred during that time (starting at Day 1 Year 6 and up to Day 365 of Year 8) by the time (in 100 women years) that the women were at risk of getting pregnant during that time.
The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.
End-of-study MBL \< 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success.
The 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 under risk of getting pregnant.
| Arm | Type | Description |
|---|---|---|
| Levonorgestrel IUS (Mirena, BAY86-5028) | EXPERIMENTAL | Mirena during extended use (Years 6 to 8). |
| Arm 1 | EXPERIMENTAL | - |
| Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours | EXPERIMENTAL | Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles. |
| Medroxyprogesterone acetate (MPA) | ACTIVE_COMPARATOR | Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles. |
| LCS12 | EXPERIMENTAL | Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro |
| LCS16 | EXPERIMENTAL | Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro |
| IUS20 (Mirena) | ACTIVE_COMPARATOR | Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro |
| Name | Type | Description |
|---|---|---|
| Levonorgestrel IUS (Mirena, BAY86-5028) | DRUG | Levonorgestrel (LNG) intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg levonorgestrel per day. |
| Levonorgestrel IUS (LCS, BAY86-5028) | DRUG | In Vitro release rate: 12µg LNG/24h |
| Medroxyprogesterone acetate | DRUG | Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles. |
| Levonorgestrel IUS (BAY86-5028, G04209B) | DRUG | Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years |
| Levonorgestrel IUS (BAY86-5028, G04209C) | DRUG | Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years |
Inclusion Criteria: * Signed and dated informed consent * Women, 18 to 35 years of age at the time of screening (visit 1) who are currently using Mirena for contraception or for contraception and heavy menstrual bleeding. The duration of use of the current Mirena has to be at least 4 years 6 months...
Levonorgestrel IUS is an intrauterine system developed for contraception and for menorrhagia, which is heavy menstrual bleeding. Bayer AG has studied it in both indications, including a Phase 3 trial in women with idiopathic menorrhagia and multiple Phase 3 contraception studies.
Levonorgestrel IUS delivers levonorgestrel, which acts as an agonist at the progesterone receptor, also known as PGR. This progestin receptor activity is the basis for its contraceptive effect and for reducing menstrual blood loss in women with menorrhagia.
Levonorgestrel IUS is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer has sponsored the clinical development program for the intrauterine system across contraception and menorrhagia indications.
Levonorgestrel IUS has reached Phase 3 development. Three Phase 3 trials have been completed, along with one Phase 2 dose-finding study, and there are currently no active trials listed for the program.
Completed studies include NCT02985541, the Mirena Extension Trial in contraception; NCT00884260, a Phase 3 contraceptive study in China, Australia, and South Korea; NCT00360490, a Phase 3 menorrhagia study; and NCT00185380, a Phase 2 dose-finding study of an ultralow-dose system.
Levonorgestrel IUS is also known as Mirena, and it has been referenced under the codes BAY86-5028, G04209B, and LCS. These names and identifiers refer to the same levonorgestrel-releasing intrauterine system developed by Bayer.