Acceptability and feasibility of Micralax (R) applicators and of methyl cellulose gel placebo for large-scale clinical trials of vaginal microbicides

Objective(s): To evaluate the feasibility and acceptability of the Micralax (R) applicator and of methyl cellulose placebo gel for use in vaginal micro bicide clinical trials. Design: A two-centre prospective study following women for 2 months. Setting: Two primary health care clinics in South Africa. Patients, participants: Female volunteers (n = 28) 18 years or older who we re HIV negative and had no clinically detectable genital tract abnormalitie s or reproductive tract infections. Interventions: Participants used pre-filled Micralax(R) applicators to appl y methyl cellulose gel every other day, as well as up to 1 h before to ever y episode of vaginal sex. Main outcome measure(s): Consistency in the weight of gel dispensed per app lication; side-effects attributed to applicator or gel use; and acceptabili ty of the applicator and of the gel. Results: Over a 2 month follow-up period the 22 women completing the study reported no adverse events related to gel or applicator use. The Micralax(R ) applicator proved acceptable. The gel was not too messy and did not reduc e sexual frequency or pleasure. On average, the applicator dispensed 4.7 ml per use (close to the 4 ml planned). Conclusions: The Micralax(R) applicator performs well as a delivery system for potential vaginal microbicides; and methyl cellulose is an appropriate placebo for future microbicide trials. (C) 2001 Lippincott Williams & Wilki ns.