Clotrimazole 500 mg Vaginal Tablet Therapeutic Equivalence Clinical Trial

Phase 4

• Registration Number: CTRI/2013/01/003288
• Lead Sponsor: ACTOR PHARMA PTY LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Female patients aged between 18 to 45 years.

Patient has a primary diagnosis of Vulvovaginal Candidiasis (VVC).

Patient willing to give their informed consent.

Postmenarcheal females with a diagnosis of VVC will be included based on the criteria listed below.

To be clinically evaluable, Patient should have a clinical diagnosis of VVC based on history and physical examination (including vaginal examination). Signs and symptoms to be evaluated include: itching, burning, irritation, edema, erythema and/or excoriation of the vagina/vulva. Each evaluated signs and/or symptoms should be given a numerical rating based on severity

Documented Papanicolaou (Pap) test at baseline or during the previous 12 months reported as either â??negative for intraepithelial lesion or malignancyâ?? or â??ASCUS-atypical squamous cells of undetermined significance.â??

At baseline, >= 50% of the patient should have at least moderate severity of VVC, defined as having a minimum composite Vulvovaginal signs and symptoms score of 2.

Presence of at least one Vulvovaginal symptom (Vulvovaginal itching, burning, or irritation) as assessed by the investigator at baseline.

Presence of at least one Vulvovaginal sign (Vulvovaginal erythema, edema, or excoriation) as assessed by the investigator at baseline

Clinical diagnosis of symptomatic Vulvovaginal Candidiasis (VVC) confirmed at baseline by positive KOH wet mount test (i.e., when examined microscopically, vaginal secretions obtained by swab of the vaginal mucosa, placed on a slide and diluted with 10% room temperature potassium hydroxide (KOH) reveal filamentous hyphae/ pseudohyphae and/or budding yeast cells).

Exclusion Criteria

Pregnant or nursing women.

Patient has Menstruation at the time of diagnosis.

Diabetes mellitus [NOTE: If diabetic women are enrolled, it is important that their diabetes be

controlled (Fasting blood glucose should be <200 mg/dl) and the proportion of diabetic patient

be similar among all treatment groups, because cure rates might differ in diabetic versus non-diabetic women].

Insufficiency of liver and/or of kidney (Creatinine > 2.0 mg/dl).

Use of systemic, topical (applied to the vulva) or vaginal antibiotics, antifungals or anti-trichomonals within 7 days prior to randomization.

Use of any systemic corticosteroid, immunosuppressive, or immune-stimulating drug within 3

months prior to randomization.

Presence of concomitant vulvovaginitis caused by other infections (e.g., bacterial vaginosis,

Trichomonas vaginalis, Chlamydia trachomatis or Neisseria gonorrhoeae).

Patient with other infectious causes of vulvovaginitis (e.g., bacterial vaginosis, Trichomonas

vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, or human papilloma

virus).

Sexual intercourse 24 hours before the KOH mount test.

Presence of another vaginal or vulvar condition that would confound the interpretation of

clinical response.

Women who will be under treatment or surgery during the study period for cervical

intraepithelial neoplasia (CIN) or cervical carcinoma.

History of allergy or sensitivity to clotrimazole, related compounds or any component of the

formulation.

HSV-IIâ??Tzanck Smear positive patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint of the study is the proportion of patient with therapeutic cure, defined as both <br/ ><br>mycological cure and clinical cure, at the test-of-cure visits conducted on study daysTimepoint: Visit 1 (Day -2) <br/ ><br>Visit 2 (Day 0) <br/ ><br>Visit 3 (Day 3±1) <br/ ><br>Visit 4 (Day 14±2) <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
The type of AE(s), number of AE(s), frequency of AE(s) and proportion of patients with AE(s). <br/ ><br>The severity, seriousness and the relationship of AE to the treatment. <br/ ><br>Vital signs (sitting blood pressure, oral temperature, radial pulse rate and respiratory rate) will be measured at enrolment, prior to dosing (at the time of Check-in), 30 minutes after post dose, at the time of discharge and at follow up visit i.e. visit 3 and visit 4 <br/ ><br>Timepoint: Visit 2(Day 0),Visit 3(Day 3±1)