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 a small molecule combination drug containing the progestin drospirenone and the estrogen ethinyl estradiol. It is also known by the brand name Gianvi. It is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA.
Drospirenone/Ethinyl Estradiol targets NR3C2 and PGR. Both targets are acted on as antagonists. NR3C2 is the mineralocorticoid receptor and PGR is the progesterone receptor, so the drospirenone component binds these receptors while the ethinyl estradiol component provides estrogenic activity.
Drospirenone/Ethinyl Estradiol is developed by Teva Pharmaceutical Industries Limited, which trades on the stock market under the ticker TEVA. Teva is the company associated with the Gianvi brand of this drospirenone and ethinyl estradiol combination product.
Drospirenone/Ethinyl Estradiol is in Phase 1 clinical development. It is an investigational product, and the two recorded Phase 1 trials have both been completed. No active trials are currently listed for this asset.
Two completed Phase 1 trials have studied Drospirenone/Ethinyl Estradiol 3 mg/0.02 mg tablets in healthy female volunteers in the United States. NCT01182207 evaluated the tablets under non-fasting conditions with 33 participants, and NCT01182194 evaluated them under fasting conditions with 32 participants. Both were randomized and active controlled.
Yes, Gianvi is a brand name for Drospirenone/Ethinyl Estradiol. The combination of drospirenone and ethinyl estradiol is also known as Drospirenone/Ethinyl Estradiol (Gianvi). Readers searching for Gianvi are looking at the same drospirenone and ethinyl estradiol product developed by Teva Pharmaceutical Industries Limited.