Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ethinyl Estradiol+ Levonorgestrel · 1 trial · 1 indication
Cmax of Ethinyl Estradiol and Levonorgestrel.
Tmax of Ethinyl Estradiol and Levonorgestrel.
β of Ethinyl Estradiol and Levonorgestrel.
t1/2 of Ethinyl Estradiol and Levonorgestrel.
AUCt of Ethinyl Estradiol and Levonorgestrel.
AUCinf of Ethinyl Estradiol and Levonorgestrel.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Period 1 & 2 | EXPERIMENTAL | In Period 1, participants will receive a single dose of ethinyl estradiol and levonorgestrel. In Period 2, participants will receive multiple daily doses of ABBV-722 and a single dose of ethinyl estradiol and levonorgestrel. |
| Name | Type | Description |
|---|---|---|
| Ethinyl Estradiol + Levonorgestrel | DRUG | Oral |
| ABBV-722 | DRUG | Oral |
Inclusion Criteria: * Laboratory values meet the criteria specified in the protocol. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG). Exclusion Criteria: * History of an...
Ethinyl Estradiol + Levonorgestrel is a small molecule combination of two hormonal agents. It is being studied by AbbVie Inc. (ABBV) in a Phase 1 drug interaction trial in healthy adult female participants. The combination is not approved for any new indication based on this development program.
Ethinyl Estradiol + Levonorgestrel targets ESR1, the estrogen receptor alpha. The target class is an agonist. In the Phase 1 trial, the combination was assessed for its effect on drug levels when co-administered with ABBV-722.
Ethinyl Estradiol + Levonorgestrel is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor of the Phase 1 trial evaluating the combination.
Ethinyl Estradiol + Levonorgestrel is in Phase 1 clinical development. The single Phase 1 trial has been completed. It is an investigational combination and has not been approved by the FDA for any indication based on this program.
Ethinyl Estradiol + Levonorgestrel has been studied in one completed Phase 1 trial, NCT07502417. The trial enrolled 15 healthy adult female participants in the United States and assessed the effect of ABBV-722 on ethinyl estradiol and levonorgestrel drug levels.