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CONRAD A10-114

Status
Completed
Phase
I
Principal Investigator(s)
Christine K. Mauck
Objective

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.

Prevention Option(s)
Hormonal Contraceptives and HIV
Microbicides
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Tenofovir 1% vaginal gel DMPA
Mode of Delivery
Gel
Intramuscular
Products
1% tenofovir gel
DMPA
ARMs
Experimental
Description
Tenofovir 1% vaginal gel Oral contraceptive: LNG 150 mcg and EE 30 mcg
Mode of Delivery
Gel
Tablet
Products
1% tenofovir gel
ARMs
Experimental
Trial Sponsors
CONRAD
March 2012
March 2014
Enrollment
72
18
Years
50
Years
Population
Women
Sites

Eastern Virginia Medical School

Norfolk, Virginia
United States of America

Profamilia

Santo Domingo
Dominican Republic

University of Pittsburgh School of Medicine, Center for Family Planning Research

Pittsburgh, Pennsylvania
United States of America