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):Microbicides
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionTenofovir 1% vaginal gel
DMPA
Mode of DeliveryGel, Intramuscular
ARMsExperimental
DescriptionTenofovir 1% vaginal gel
Oral contraceptive: LNG 150 mcg and EE 30 mcg
Mode of DeliveryGel, Tablet
ARMsExperimental
Official Code:
NCT01421368
Trial Sponsors:
CONRAD
Start Date
End Date
March 31, 2012
March 31, 2014
Enrollment:72
Age range:
18 Years ↔
50 Years
Population:Cisgender Women