OBJECTIVE(S): To evaluate the feasibility and acceptability of the Micralax applicator and of @entity5498 cellulose placebo gel for use in vaginal microbicide clinical trials. DESIGN: A two-centre prospective study following @entity1 for 2 months. SETTING: Two primary health care clinics in South Africa. @entity1 , @entity1 : Female volunteers (n = 28) 18 years or older who were @entity645 negative and had no clinically detectable genital tract @entity5860 . INTERVENTIONS: @entity1 used pre-filled Micralax applicators to apply @entity5498 cellulose gel every other day, as well as up to 1 h before to every episode of vaginal sex. MAIN OUTCOME MEASURE(S): Consistency in the weight of gel dispensed per application; side-effects attributed to applicator or gel use; and acceptability of the applicator and of the gel. RESULTS: Over a 2 month follow-up period the 22 @entity1 completing the study reported no adverse events related to gel or applicator use. The Micralax applicator proved acceptable. The gel was not too messy and did not reduce sexual frequency or pleasure. On average, the applicator dispensed 4.7 ml per use (close to the 4 ml planned). CONCLUSIONS: The Micralax applicator performs well as a delivery system for potential vaginal microbicides; and @entity5498 cellulose is an appropriate placebo for future microbicide trials.

Acceptability and feasibility of Micralax applicators and of XXXX cellulose gel placebo for large-scale clinical trials of vaginal microbicides.

@entity1 :: ('9606', 'Species') :: ['women', 'PATIENTS', 'Participants', 'PARTICIPANTS'] @entity5860 :: ('MESH:D060737', 'Disease') :: ['abnormalities or reproductive tract infections'] @entity5498 :: ('CHEBI:32875', 'Chemical') :: ['methyl'] @entity645 :: ('57667', 'Species') :: ['HIV']
@entity5498 :: (CHEBI:32875,Chemical) :: ['methyl']
