Management of intravaginal warts in women with 5-fluorouracil (1%) in vaginal hydrophilic gel: a placebo-controlled double-blind study

The purpose of this placebo-controlled, double-blind study was to determine the safety, tolerability and clinical efficacy of 5-fluorouracil (1%) in a vaginal hydrophilic gel (hydroxyethylcellulose, 1%) to cure intravaginal p apillomas in women. Pre-selected, 60 women ranging between 18 and 50 years of age (mean 24.6), having 312 vaginal condylomas (mean 5.2) joined the stu dy. The diagnosis of human papillomavirus (HPV) was established with clinic al, histopathological and polymerase chain reaction (PCR) techniques. Subje cts were randomized into 2 parallel groups. Each patient was allocated a pr e-coded tube 15 g (active or placebo) with graduated vaginal applicators (d isposable), and instructions how to insert 4g of the trial medication deep into the vagina once at bedtime on every other day (1, 3 and 5) per week, t o visit the clinic on day 7 for clinical evaluations and to receive the sam e pre-coded replacement to continue the regimen for another week. A maximum 12 applications were to be used in 4 weeks. Cure was defined as absence of clinical signs of infection, re-confirmed by PCR and Southern blot hybridi zation negative HPV DNA. By the end of the treatment 48.4% patients and 51. 9% lesions were cured. Breaking the code revealed that 5-fluorouracil (1%) gel had cured 83.3% patients and 87% intravaginal warts. Placebo resolved 1 3.3% patients and 14% condylomas; (active gel versus placebo; P<0.001). Twe lve patients (20%) mostly in the active gel experienced mild erythema, eros ion and oedema, with no drop-outs. Among cured patients 3 had a relapse aft er 16 months. in conclusion, the clinical results of the study demonstrate that 5-fluorouracil (1%) in a vaginal hydrophilic gel is safe, tolerable an d significantly more effective than placebo to cure intravaginal warts in w omen.