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Also known as Levonorgestrel (Postday), Levonorgestrel, Levonorgestrel (BAY98-7196)
levonorgestrel/ Microlut · 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 developed by Bayer AG for contraception and endometriosis. It is a progestin-based therapy studied in women aged 18 years and older. Development has reached Phase 3 for contraception, with Phase 2 work completed in endometriosis.
Levonorgestrel targets the progesterone receptor, or PGR, where it acts as an agonist. By binding and activating this receptor, it produces progestogenic effects that underpin its use in contraception and in endometriosis. The target class is a receptor agonist.
Levonorgestrel is developed by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer is the sponsor behind the clinical program covering contraception and endometriosis indications.
Levonorgestrel is in Phase 3 development for contraception and has completed Phase 2 study in endometriosis. It is an investigational small molecule and is not described as approved. Two completed Phase 3 trials support the contraception program, and no trials are currently active.
Completed trials include NCT03074045, a Phase 3 user satisfaction and tolerability study of LCS16 versus a combined oral contraceptive in Russia with 145 participants, and NCT02403401, a Phase 3 one-year safety and contraceptive efficacy study of an intravaginal levonorgestrel ring in the United States and Japan with 1,471 participants. NCT02203331 was a Phase 2 dose-finding and proof-of-concept study in endometriosis.
Levonorgestrel is also known by several other names, including Levonorgestrel (Postday), Levonorgestrel (BAY98-7196), and Levonorgestrel (Kyleena, BAY86-5028). These refer to the same active compound, levonorgestrel, which is the progestin studied across the Bayer contraception and endometriosis programs.