Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EE/DRSP · 2 trials · 1 indication
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample
The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.
The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.
The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.
The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.
The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample
| Arm | Type | Description |
|---|---|---|
| EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300) | EXPERIMENTAL | single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) |
| EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca) | EXPERIMENTAL | single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium \[MTHF-Ca\]) |
| L-5-MTHF Ca 0.451 mg (Metafolin) | EXPERIMENTAL | single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium \[MTHF-Ca\]) |
| EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) | EXPERIMENTAL | single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) |
| EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca) | EXPERIMENTAL | single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium \[MTHF-Ca\]) |
| Name | Type | Description |
|---|---|---|
| EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300) | DRUG | Treatment group A: Single 1 film-coated tablet (Ethinylestradiol \[EE\] 0.02mg / Drospirenone \[DRSP\] 3mg) taken orally under fasting condition at intervals of at least one menstrual cycle. |
| EE 0.02 mg/DRSP 3 mg/L-5-MTHF Ca 0.451 mg (EE20/DRSP/L-5-MTHF Ca) | DRUG | Treatment group B: Single 1 film-coated tablet (Ethinylestradiol \[EE\] 0.02mg / Drospirenone \[DRSP\] 3mg / L-5-methyltetrahydrofolate \[L-5-MTHF\] 0.451mg) taken orally under fasting condition at intervals of at least one menstrual cycle. |
| L-5-MTHF 0.451mg (Metafolin) | DRUG | Treatment group C: Single 1 coated tablet (L-5-methyltetrahydrofolate \[L-5-MTHF\] 0.451mg) taken orally under fasting condition at intervals of at least one menstrual cycle. |
| EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) | DRUG | single oral administration of 1 coated tablet SH T470FA (Yasmin, film-coated tablets with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) |
| EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca) | DRUG | single oral administration of 1 coated tablet SH T04532A (film-coated tablet with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin |
| L-5-MTHF Ca 0.451 mg (Metafolin) | DRUG | single oral administration of 1 coated tablet SH T04532C, containing 0.451 mg Metafolin |
Inclusion Criteria: * Healthy female volunteer * Age: 18 - 38 years inclusive * Body mass index (BMI)1: ≥ 19 and \< 28 kg/m² * Regular cyclic menstrual periods at screening OR when using combined oral contraceptives during the recruitment period reporting of natural cyclic menstrual periods prior t...
EE/DRSP is a combination of ethinylestradiol and drospirenone being developed for contraception. It is an investigational small molecule in Phase 1 clinical development, studied in healthy female volunteers aged 18 years and older.
EE/DRSP is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is currently in Phase 1 clinical trials for contraception.
EE/DRSP is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 92 participants enrolled. The drug is investigational and not yet approved for use.
EE/DRSP has been studied in two completed Phase 1 trials: NCT01253174, which enrolled 48 participants in Germany, and NCT01253187, which enrolled 44 participants in the Netherlands. Both trials investigated bioequivalence of different tablet formulations for contraception.
EE/DRSP refers to the combination of ethinylestradiol and drospirenone, which are the active ingredients in the tablet formulations Yasmin and YAZ. The clinical trials compared these formulations with versions containing levomefolate calcium.