Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use

Phase 1 Completed 72 enrolled CONRAD

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of the study is to examine the effects of two contraceptive methods and the menstrual cycle on the pharmacokinetics, pharmacodynamics of tenofovir 1% gel and the effect of the contraceptive methods on markers of mucosal safety.

Timeline

Start: 2012-03
Primary completion: 2014-03
Completion: 2014-03

Publications

Zalenskaya IA, Chandra N, Yousefieh N, Fang X, Adedipe OE, Jackson SS, Anderson SM, Mauck CK, Schwartz JL, Thurman AR, Doncel GF. Use of contraceptive depot medroxyprogesterone acetate is associated with impaired cervicovaginal mucosal integrity. J Clin Invest. 2018 Oct 1;128(10):4622-4638. doi: 10.1172/JCI120583. Epub 2018 Sep 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EE	Unknown	30 ug	Oral
Subject	LNG	Unknown	150 ug	Oral
Subject	Tenofovir	Small molecule	1 %	Other
Subject	Tenofovir	Small molecule	4 ml	Other
Subject	medroxyprogesterone acetate	Other / unclassified	150 mg	Intramuscular

Indications

No indication recorded.