Health Condition 1: null- Vaginal Candidiasis (characterized by itching, redness and white discharge from female genitals)
Conditions
Interventions
Intervention1: Fenticonazole 600 mg vaginal capsule: The dose is 1 capsule intra-vaginal once.
Control Intervention1: Clotrimazole 500 mg vaginal tablet: The dose is 1 tablet intra-vaginal once.
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female subjects age 18 to 65 years. 2. Diagnosis of symptomatic vaginal candidiasis. 3. Presence of vulvovaginal sign as assessed by the investigator at baseline.
Exclusion criteria
Exclusion criteria: 1. Presence of concomitant vaginitis caused by other infections (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis or Neisseria gonorrhoea). 2. Subjects having history of recurrent vaginal candidiasis, defined as occurrence of four or more than four episodes in the previous 12 months. 3. Presence of another vaginal condition that would confound the interpretation of clinical response. 4. Pregnant or lactating women. 5. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the subjectâ??s ability to safely complete the study. 6. Hypersensitivity to the imidazoles and their analogues or any component of the formulation. 7. History of drug or alcohol dependency or abuse within approximately the last 2 years. 8. Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or scheduled to participate in another clinical study involving an investigational product or investigational drug during the course of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic cure at the test-of-cure visitTimepoint: Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in the composite vulvovaginal signs and symptoms score at the test-of-cure visitTimepoint: Day 8;Therapeutic cure at the end of studyTimepoint: Day 22 | — |
Countries
India
Contacts
Public ContactAmol Pendse
Glenmark Pharmaceutical Ltd
Outcome results
None listed