A clinical trial to study the effect of four different doses of a fixed dose combination of Sertaconazole + Secnidazole in patients with mixed vaginitis
- Registration Number
- CTRI/2010/091/000112
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 148
Female patients with clinical [vaginal discharge/odor] & histopathologic diagnosis of mixed bacterial/fungal vaginitis, Age: 18 to 60 years; Non-pregnant (with negative Beta-human chorionic gonadotropin test) including breast feeding females; Patient willing to comply with study procedures and requirements
Pregnant and nursing women, history of allergy to Sertaconazole and/or Secnidazole,Use of topical contraceptive preparations,Anticipation of menses during treatment,Any other condition that in the opinion of the investigator does not justify the patient's participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in clinical signs & symptoms such as Vaginal Discharge: Color & consistency; Odor, Pruritus, Burning, irritation/ Discomfort and signs such as Vaginal erythema, Vulvar erythema, Cervical erythema, polyp, erosion, Microbiological cure rate Clinical cureTimepoint: Baseline, days 7 and 14
- Secondary Outcome Measures
Name Time Method Physician?s & Patient?s Global Assessment, Safety assessmentsTimepoint: Baseline, Days 7 and 14
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