A prospective study to compare the efficacy and safety of tioconazole and clotrimazole vaginal gel in patients suffering from vulvovaginal candidiasis

Background: Vulvo vaginal candidiasis is an extremely common gynaecological condition. While clotrimazole has been the mainstay of treatment of this pathology, newer medications are now available. The study aims to compare the efficacy, compliance and safety of tioconazole single dose intravaginal gel application and clotrimazole vaginal gel for 3 days in patients suffering from vulvovaginal candidiasis.Methods: A prospective, multicentric, open label, randomized, controlled, parallel group clinical trial of 220 women with 110 in each group for the evaluation of the effects of tioconazole vaginal gel in patients suffering from candidial vaginitis. Patients were divided into two groups; Group I received tioconazole vaginal gel as topical single dose therapy administered by the treating doctor and Group II received clotrimazole vaginal gel self-administered by the patient for three days. Response to therapy in both groups was studied and compared.Results: At the end of day 7, mean score of vaginal discharge quantity had a fall of 93.3% and 92.3% in tioconazole and clotrimazole group respectively but difference was statistically insignificant. Microbiological cure rate in both the groups was similar. Reduction of vaginal irritation, vaginal itching, vaginal burning, pain in the vulval area, pain during urination or during sexual intercourse, vaginal erythema, tenderness and swelling were also comparable in both the groups.Conclusions: Tioconazole gel single dose intravaginal application is as effective as clotrimazole gel three day intravaginal application. tioconazole is safe, well accepted and tolerated by the patients and will be useful in the treatment of vulvovaginal candidiasis

A prospective study to compare the efficacy and safety of tioconazole and clotrimazole vaginal gel in patients suffering from vulvovaginal candidiasis

Background: Vulvo vaginal candidiasis is an extremely common gynaecological condition. While clotrimazole has been the mainstay of treatment of this pathology, newer medications are now available. The study aims to compare the efficacy, compliance and safety of tioconazole single dose intravaginal gel application and clotrimazole vaginal gel for 3 days in patients suffering from vulvovaginal candidiasis.Methods: A prospective, multicentric, open label, randomized, controlled, parallel group clinical trial of 220 women with 110 in each group for the evaluation of the effects of tioconazole vaginal gel in patients suffering from candidial vaginitis. Patients were divided into two groups; Group I received tioconazole vaginal gel as topical single dose therapy administered by the treating doctor and Group II received clotrimazole vaginal gel self-administered by the patient for three days. Response to therapy in both groups was studied and compared.Results: At the end of day 7, mean score of vaginal discharge quantity had a fall of 93.3% and 92.3% in tioconazole and clotrimazole group respectively but difference was statistically insignificant. Microbiological cure rate in both the groups was similar. Reduction of vaginal irritation, vaginal itching, vaginal burning, pain in the vulval area, pain during urination or during sexual intercourse, vaginal erythema, tenderness and swelling were also comparable in both the groups.Conclusions: Tioconazole gel single dose intravaginal application is as effective as clotrimazole gel three day intravaginal application. tioconazole is safe, well accepted and tolerated by the patients and will be useful in the treatment of vulvovaginal candidiasis

A multicenter, randomized, equivalence trial of a new recombinant human chorionic gonadotropin preparation versus ovitrelle® for ovulation in women undergoing intrauterine insemination following ovarian stimulation

Context: A new indigenous recombinant human chorionic gonadotropin (r-hCG) has been developed in India with a comparable pharmacological profile to that of Ovitrelle® (Merck Serono). Aims: This study aims to compare the efficacy and safety of the new r-hCG with that of Ovitrelle for induction of ovulation in women undergoing intrauterine insemination (IUI). Settings and Design: Randomized (2:1), multicenter, open-label, equivalence clinical trial conducted in India. Subjects and Methods: A total of 217 women, aged 20–37 years, undergoing IUI were administered the new r-hCG (test) 250 mcg or Ovitrelle 250 mcg (comparator) after ovarian stimulation with gonadotropins. The ovulation rate was compared as the primary outcome. In addition, pregnancy rates, incidence of adverse events (AEs), and development of immunogenicity were assessed. Statistical Analysis Used: The ovulation and pregnancy rates were compared using Chi-squared test with statistical significance at P < 0.05. Results: With 144 women in the test group and 73 in the comparator group, the ovulation rate (85.4% vs. 78.1%; P = 0.17) and pregnancy rate (serum β hCG test) (11.8% vs. 12.3%; P = 0.91) were similar in both groups. A total of 15 AEs were reported (11 in the test r-hCG group and 4 in the comparator group) in 11 women; none of these were serious, and all were judged to be unrelated to the study drug. No subject developed immunogenic reaction to the test drug. Conclusions: The new preparation of r-hCG was equivalent to the conventional preparation of r-HCG in the induction of ovulation in patients undergoing IUI