Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
levonorgestrel/ Microlut · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| levonorgestrel | EXPERIMENTAL | levonorgestrel and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. |
| norethindrone | EXPERIMENTAL | norethindrone and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. |
| desogestrel | EXPERIMENTAL | desogestrel and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. |
| dienogest | EXPERIMENTAL | dienogest and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. |
| Drospirenone/ ethinylestradiol | EXPERIMENTAL | drospirenone/ethinylestradiol and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. |
| Name | Type | Description |
|---|---|---|
| levonorgestrel/ Microlut | DRUG | In Period 1, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 1, In Period 2, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 15 In Period 3, 0.03 mg single dose administered as 1x0.03 mg tablet at Study Day 26 |
| Norethindrone/ Noriday | DRUG | In Period 1, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 1, In Period 2, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 15 In Period 3, 0.35 mg single dose administered as 1x0.35 mg tablet at Study Day 26 |
| Desogestrel/ Cerazette | DRUG | In Period 1, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 1, In Period 2, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 15 In Period 3, 0.075 mg single dose administered as 1x0.075 mg tablet at Study Day 26 |
| Dienogest/ Visanne | DRUG | In Period 1, 2 mg single dose administered as 1x2 mg tablet on Study Day 1, In Period 2, 2 mg single dose administered as 1x2 mg tablet on Study Day 15 In Period 3, 2 mg single dose administered as 1x2 mg tablet at Study Day 26 |
| Drospirenone, Ethinylestradiol/ Yasmin | DRUG | In Period 1, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 1, In Period 2, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 15, In Period 3, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 26, |
| Midazolam/ Midazolam-ratiopharm | DRUG | In Period 1, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 1, In Period 2, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 15 In Period 3, 1 mg single dose administered as 1x0.5 ml oral solution at Study Day 26 |
| Rifampicin | DRUG | In period 2, 10 mg (suspension, 0.5 ml) for 11 days at 10 mg/day In period 3, 600 mg (film-coated tablets) for 11 days at 600 mg/day |
Inclusion Criteria: * Healthy female subject based on a complete medical history, physical examination, ECG, and clinical laboratory tests * Age: 45 to 70 years (inclusive) at the first screening visit * Minimum body weight 50 kg with Body mass index (BMI) above or equal to 18.5 kg/m², and below or...
Levonorgestrel is a small molecule being studied for contraception, endometriosis, and biological availability. It is developed by Bayer AG. In clinical trials, it has been evaluated as an intravaginal ring for contraception and in a dose-finding study for endometriosis.
Levonorgestrel is developed by Bayer AG, a company traded under the ticker BAYRY. Bayer has conducted multiple clinical trials with Levonorgestrel, including Phase 3 studies for contraception and a Phase 2 study for endometriosis.
Levonorgestrel has completed Phase 3 clinical trials for contraception and a Phase 2 trial for endometriosis. It remains an investigational drug in clinical development, as no approval status has been reported for these indications.
Levonorgestrel has been studied in several completed trials. NCT02403401 was a Phase 3 safety and efficacy study of an intravaginal ring with Levonorgestrel for contraception. NCT02203331 was a Phase 2 dose-finding study for endometriosis. NCT03074045 compared a levonorgestrel-releasing system to a combined oral contraceptive.
Levonorgestrel is a progestin hormone. It works by suppressing ovulation and thickening cervical mucus to prevent sperm penetration, which is its mechanism for contraception. In endometriosis, it may reduce endometrial tissue growth through its progestogenic effects.
Yes, Levonorgestrel is commonly abbreviated as LNG. Clinical trial titles refer to it as LNG, such as in the study of an intravaginal ring with LNG for contraception. It is also known by the code name Bay98-7196 in some research contexts.