Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Drospirenone/Ethinyl Estradiol · 2 trials · 1 indication
Bioequivalence based on Drospirenone Cmax.
Bioequivalence based on Drospirenone AUC0-t.
Bioequivalence based on Drospirenone AUC0-inf.
Bioequivalence based on Ethinyl Estradiol Cmax.
Bioequivalence based on Ethinyl Estradiol AUC0-t.
Bioequivalence based on Ethinyl Estradiol AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| Investigational Test Product | EXPERIMENTAL | Drospirenone/Ethinyl Estradiol Tablets, 3 mg/0.02 mg |
| Reference Listed Drug | ACTIVE_COMPARATOR | YAZ® Tablets, 3 mg/0.02 mg |
| Name | Type | Description |
|---|---|---|
| Drospirenone/Ethinyl Estradiol (Gianvi®) | DRUG | 3 mg/0.02 mg Tablets |
| YAZ® | DRUG | 3 mg/0.02 mg Tablets |
Inclusion Criteria: * Subjects who were informed of the nature of the study and agreed to read, review, and sign the informed consent document prior to Period I dosing. * Subjects who completed the screening process within 28 days prior to Period I dosing. * Subjects who were healthy, adult, menstr...
Drospirenone/Ethinyl Estradiol is an investigational small molecule combination being studied in healthy female volunteers. It is currently in Phase 1 clinical development, with studies evaluating the 3 mg/0.02 mg tablet formulation under fasting and non-fasting conditions. The drug is not approved and remains in clinical trials.
Drospirenone/Ethinyl Estradiol is being developed by Teva Pharmaceutical Industries Limited, traded on the stock exchange under the ticker TEVA. The company is conducting Phase 1 clinical trials for this combination product in the United States.
Drospirenone/Ethinyl Estradiol is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 65 healthy female participants. The drug is investigational and has not received FDA approval.
Drospirenone/Ethinyl Estradiol has two completed Phase 1 trials: NCT01182194, a fasting condition study with 32 participants, and NCT01182207, a non-fasting condition study with 33 participants. Both trials enrolled healthy females aged 18 years and older in the United States.
Drospirenone/Ethinyl Estradiol is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials were bioavailability studies in healthy volunteers, and the drug has not progressed beyond early-stage testing.