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 being studied for contraception and for menorrhagia, which is heavy menstrual bleeding. It is a small molecule endocrine therapy in Phase 3 clinical development. The system releases levonorgestrel locally within the uterus to achieve its effects.
Levonorgestrel IUS is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. Bayer is conducting clinical trials to evaluate the safety and efficacy of this intrauterine system for contraception and menorrhagia.
Levonorgestrel IUS is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Three Phase 3 trials have been completed, along with one Phase 2 trial, all of which have finished.
Levonorgestrel IUS has completed several clinical trials. NCT00360490 studied its effect on menstrual blood loss in women with menorrhagia. NCT00884260 evaluated it for contraception in a Phase 3 study. NCT02985541 was an extension trial for contraception. NCT00185380 was a Phase 2 dose-finding study for contraception.
Levonorgestrel IUS is related to Mirena, as one clinical trial, NCT02985541, is titled 'Mirena Extension Trial.' This trial studied Levonorgestrel IUS for contraception, suggesting the drug may be compared to or used in conjunction with the Mirena system, though the exact relationship is not specified.
Levonorgestrel IUS trials have enrolled a total of 2,024 participants across four completed studies. The trials are randomized and actively controlled, but not double-blinded. They do not use biomarker selection. The studies included healthy volunteers in some cases and were conducted in multiple countries including the United States, China, and European nations.