Annovera™ Drug-Drug Interaction Study

Phase 1 Completed 67 enrolled TherapeuticsMD

RandomizedCrossoverOpen-labelTreatment

Summary

A Drug-Drug Interaction (DDI) study to evaluate the effects of itraconazole and rifampin on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol from the Annovera Contraceptive Vaginal System (CVS)

Timeline

Start: 2020-02-12
Primary completion: 2021-01-06
Completion: 2021-01-06

Publications

Plagianos M, Lansiaux M, Kumar N, Graham S, Sussman H, Kushner H, Creasy G, Bernick B, Haddad LB. A drug-drug interaction study to evaluate the effects of strong CYP3A4 inducer on the pharmacokinetics of segesterone acetate and ethinyl estradiol in a contraceptive vaginal system. Contracept Reprod Med. 2025 Nov 26;10(1):78. doi: 10.1186/s40834-025-00414-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Itraconazole	Small molecule	200 mg	—
Comparator	Rifampin	Small molecule	600 mg	—
Comparator	Segesterone Acetate	Small molecule	150 ug	Other
Comparator	ethinyl estradiol	Small molecule	13 ug	Other

Indications

No indication recorded.