An Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication Miconazole Nitrate on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring in Normal Ovulating Women

Phase 1 Completed 45 enrolled Population Council

RandomizedSingle-groupOpen-labelTreatment

Summary

To evaluate the pharmacokinetics (PK) of EE and NES released from the CVR in the presence of a single dose and multiple doses of antimycotic co-medication (miconazole nitrate suppository or cream).

Timeline

Start: 2014-03
Primary completion: 2015-04
Completion: 2015-04

Publications

Simmons KB, Kumar N, Plagianos M, Roberts K, Hoskin E, Han L, Alami M, Creasy G, Variano B, Merkatz R. Effects of concurrent vaginal miconazole treatment on the absorption and exposure of Nestorone(R) (segesterone acetate) and ethinyl estradiol delivered from a contraceptive vaginal ring: a randomized, crossover drug-drug interaction study. Contraception. 2018 Mar;97(3):270-276. doi: 10.1016/j.contraception.2017.10.010. Epub 2017 Oct 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Miconazole	Small molecule	—	Other
Subject	Segesterone Acetate	Small molecule	150 ug	Other
Subject	ethinyl estradiol	Small molecule	15 ug	Other

Indications

No indication recorded.