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 (EE) and drospirenone (DRSP), a small molecule product developed by Bayer AG for contraception. It is studied in oral tablet formulations, including the Yasmin and YAZ product lines, and has been evaluated in bioequivalence trials in healthy female volunteers.
EE/DRSP is used for contraception. The clinical trials listed for this asset enroll healthy female volunteers aged 18 years and older and list contraception as the condition under study. The formulations examined include EE 0.03 mg with DRSP 3 mg and EE 0.02 mg with DRSP 3 mg.
Bayer AG develops EE/DRSP. Bayer trades on the OTC market under the ticker BAYRY. The company is associated with the Yasmin and YAZ oral contraceptive brands, which contain ethinylestradiol and drospirenone, and with the bioequivalence studies conducted for these formulations.
EE/DRSP is in Phase 1 clinical development. Both listed trials are Phase 1 bioequivalence studies, and both are completed. The program is investigational in this dataset, and the trials were active controlled, randomized, and conducted in healthy female volunteers.
EE/DRSP has been studied in two completed Phase 1 bioequivalence trials: NCT01253187, conducted in the Netherlands with 44 participants, and NCT01253174, conducted in Germany with 48 participants. Both enrolled healthy female volunteers aged 18 years and older and listed contraception as the condition.
EE/DRSP refers to ethinylestradiol combined with drospirenone, and it is also known as EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) and EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300). Related ethinylestradiol/levonorgestrel combinations include Microgynon (BAY86-4977).