Conditions: Microbicide Applicator
Keywords: Microbicide, Applicator, Safety
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 25
Healthy volunteers: yes

Brief summary:
The primary objective of this study is to compare the effect of two vaginal applicators, delivering the candidate microbicide Tenofovir, on symptoms and signs of irritation of the external genitalia, cervix and vagina as seen on colposcopy after seven days of twice daily use.

The secondary objectives are to:

1. Evaluate and compare the dosing accuracy and precision of the user-filled applicator and pre-filled applicator with the candidate microbicide, Tenofovir.
2. Compare the acceptability of the user-filled applicator with the pre-filled applicator.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Tenofovir
Intervention descriptions: intervention 1: Delivered using prefilled and user-filled applicator

Protocol document: