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Also known as Levonorgestrel Emergency Pill (BAY86-5028)
Levonorgestrel Emergency Pill · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Levonorgestrel Emergency Pill (BAY86-5028) | DRUG | Single dose of 1.5 mg coated tablet |
| Postinor 2 | DRUG | Single dose of 1.5 mg tablet |
| Levonorgestrel Emergency Pill (BAY86-5028/Opxion) | DRUG | Single dose of 1.5 mg coated tablet |
| Levonorgestrel (Postday) | DRUG | Single dose of two 0.75 mg tablets |
Inclusion Criteria: * Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis. Exclusion Criteria: * History of illnesses or any organic abnormalities that could affect the results of the stud...
Levonorgestrel Emergency Pill is being developed for contraception, specifically postcoital contraception, which is emergency contraception used after unprotected intercourse. It is an oral small molecule formulation. The program is in Phase 1 development, and the completed trials were bioequivalence studies rather than efficacy studies in the intended patient population.
Levonorgestrel Emergency Pill acts as an agonist at PGR, the progesterone receptor. By binding and activating this nuclear hormone receptor, it modulates progesterone-responsive signaling in reproductive tissue. This target class, a progesterone receptor agonist, is the mechanism described for the levonorgestrel molecule in this emergency contraception program.
Bayer AG is the developer of Levonorgestrel Emergency Pill. Bayer trades on the OTC market under the ticker BAYRY. The company is responsible for the clinical development program, which includes the completed Phase 1 bioequivalence studies conducted in Mexico.
Levonorgestrel Emergency Pill is in Phase 1 development. It is an investigational product and has not been approved. Two Phase 1 trials are listed as completed, and no trials are currently active. The completed studies were crossover bioequivalence studies comparing oral formulations of levonorgestrel.
Three completed Phase 1 trials are listed for Levonorgestrel Emergency Pill: NCT01096498 and NCT01096485, each enrolling 24 healthy male volunteers, and NCT01073904, enrolling 32 healthy male volunteers. All three were crossover bioequivalence studies of oral levonorgestrel formulations conducted in Mexico. No trials are currently active.
Yes, Levonorgestrel Emergency Pill is also known as BAY86-5028, and it has been referenced as BAY86-5028/Opxion. These are alternative identifiers for the same Bayer development program. Readers searching for BAY86-5028 or Opxion are looking at the same levonorgestrel emergency contraception asset.