a clinical trial to study the effects of two drugs, butoconazole and clotrimazole in patients with vulvovaginal candidiasis.

Phase 3

Completed

Registration Number: CTRI/2010/091/000120

Lead Sponsor: Sun Pharmaceutical Industries Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

1. Female patients aged between 18 and 65 years.
2. Has a primary diagnosis of vulvovaginal candidiasis.
3. Patient willing to give their informed consent.

Exclusion Criteria

1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
2. Patients with vaginal trichomonas infection or clue cells of Gardnerella vaginalis vaginitis.
3. Patients having history of recurrent vulvovaginal candidiasis, defined as occurrence of four or more than four episodes in the previous 12 months.
4. Patients having hypersensitivity to imidazole derivatives.
5. Patients on the treatment with an oral or intravaginal antifungal medication during a week before enrollment.
6. Patients on therapy with antibiotics, systemic antimycotics, corticosteroids, or immunosuppressive drugs.
7. Menstruating patients or patients expecting menses during treatment period.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Average change from baseline to end of study in severity score of following sign/symptoms based on four point scale (Appendix-I)<br> 1.Erythema<br> 2.Swelling<br> 3.Excoriation<br> 4.Ulceration<br> 5.Discharge<br> 6.Itching<br> 7.Burning<br><br>2. Percentage of patients clinically cured<br>3. Percentage of patients microbiologically cured<br>4. Percentage of patients therapeutically cured<br>Timepoint: 1. Day 0, Day 13 and day 35<br>2. Day 13, Day 35<br>3. Day 13<br>4. Day 13<br>

Secondary Outcome Measures

Name	Time	Method
1. Average change from baseline to end of study in Clinical Global Impression on Severity (CGI-S)<br>2. Clinical Global Impression on Improvement (CGI-I) in patients<br>Timepoint: 1. Day 0, Day 13 and day 35<br>2. Day 13, Day 35<br>