Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Levonorgestrel · 3 trials · 2 indications
5-point Likert item 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied
Pearl Index = Number of pregnancies per 100 woman-years of exposure
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.
| Arm | Type | Description |
|---|---|---|
| Test | EXPERIMENTAL | LCS16 (Low-dose LNG IUS) |
| Reference | ACTIVE_COMPARATOR | COC (Yarina) |
| Levonorgestrel (BAY98-7196) | EXPERIMENTAL | Vaginal ring containing 170 mg levonorgestrel |
| Placebo | PLACEBO_COMPARATOR | Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection |
| Levonorgestrel | EXPERIMENTAL | Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection |
| Anastrozole 300 µg/d + Levonorgestrel | EXPERIMENTAL | Anastrozole 300 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection |
| Anastrozole 600 µg/d + Levonorgestrel | EXPERIMENTAL | Anastrozole 600 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection |
| Anastrozole 1050 µg/d + Levonorgestrel | EXPERIMENTAL | Anastrozole 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection |
| Lupron / Leuprolide acetate | ACTIVE_COMPARATOR | Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection |
| Name | Type | Description |
|---|---|---|
| Levonorgestrel (Kyleena, BAY86-5028) | DRUG | Low-dose LNG IUS with an initial in vitro release rate of 16 μg LNG/day, used continuously. The total LNG content in LCS16 is 19.5 mg. Administered intrauterine, for 12 months with an option for extended use for up to 5 years |
| Ethinyl estradiol and drospirenone (Yarina, BAY86-5131) | DRUG | COC tablet containing 30 μg ethinyl estradiol and 3 mg drospirenone (taken on cycle days 1-21, inclusive, followed by a 7-day tablet-free week) for 12 months |
| Levonorgestrel (BAY98-7196) | DRUG | Levonorgestrel 40 µg/d intravaginal ring (treatment for 365 days, 28 days wearing period for each ring) |
| Placebo | DRUG | Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection |
| Levonorgestrel | DRUG | Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection |
| Anastrozole | DRUG | Participants received Anastrozole 300 µg/d or 600 µg/d or 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection |
| Lupron / Leuprolide acetate | DRUG | Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection |
Inclusion Criteria: * The subject has signed and dated the Informed Consent Form (ICF). * The subject is healthy when requesting contraception. * The subject is between 18 - 29 years of age (inclusive) at the time of signing the ICF. * The subject has normal or clinically insignificant cervical sme...
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.