Efficacy and tolerability of two intravaginal formulations containing clindamycin plus clotrimazole in women with vaginal infections: A pilot study

Aims: To compare the effectiveness and tolerability of ClinSupV3 (soft gelatine capsule) versus ClinSupV3-ER (Extendedrelease tablet) in vaginal infections. Subjects and Methods: Following baseline vaginal examination, 66 women having clinical diagnosis of vaginal infection were randomized to receive three doses [once daily] of ClinSupV3 (SG-group) or ClinSupV3-ER (ER-group) per vagina and followed up for assessing resolution of clinical and microbiological evidence of vaginal infection by 8th day; maintenance of clinical and microbiological cure at 29th day; and occurrence of side effects. Statistical analysis used: Results were presented using descriptive statistics and analyzed by Chi square and Fischer’s Exact test. Results: 27 women from SG-group and 30 women from ER-group completed the study. In SG-group, 69.23% had complete cure and 7.69% had partial remission at 8th day of which 88.89% maintained remission, while in ER-group 73.68% women had a complete cure of which 85.71% maintained remission on 29th day. Delayed remission was observed in 25% women from SG-group and 60% women from ER-group, while none of the women experienced intolerable adverse effects. Conclusion: Both formulations containing clindamycin plus clotrimazole were effective, as empiric therapy, in inducing and maintaining microbiological as well as clinical remission in women with clinical diagnosis of vaginal infection to a similar extent. Amongst individual infections, trichomoniasis showed least response. Neither of the two formulations could treat trichomoniasis by end of first week, though there was a delayed response of similar magnitude with both formulations.

Keywords: Clindamycin, Clotrimazole, Vaginal formulation, Vaginal infections.