CTRI/2023/02/049628
Not yet recruiting
Phase 3
A randomized, double blind, comparative clinical study to compare and evaluate Efficacy and Safety of the Candimilt® 500 vaginal capsules (Miltonia Health Science Ltd) containing Clotrimazole 500 mg and the original drug Canesten® vaginal tablets containing Clotrimazole 500 mg, Bayer AG, Germany in patients with vulvovaginal candidiasis
MILTONIA HEALTH SCIENCE LTD0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: B373- Candidiasis of vulva and vagina
- Sponsor
- MILTONIA HEALTH SCIENCE LTD
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Women with the symptoms of vulvovaginal candidiasis (based on symptoms and signs after speculum examination);
- •2\. Age at least 18 years;
- •3\. Capable of giving written informed consent;
- •4\. Agree to no intercourse for 8 days from the day of beginning of treatment;
- •5\. Agree not to douche or use any intra\-vaginal products during the study period (including tampons, medications and devices);
- •6\. Non\-pregnant Female patients aged 18 years or more and clinically diagnosed with vulvovaginal candidiasis were included;
- •7\. Capable of giving written informed consent and willing to follow the investigational study procedures and report AEs.
- •8\. Subjects must not be on their menstrual period on the day of screening and do not anticipate their period to begin during treatment (3 days);
- •9\. Subjects must be using an acceptable method of birth control, willing to refrain from sexual intercourse from the date of screening until the follow\-up visit (approximately 7 days later);
- •10\. Willing to refrain from the use of any intravaginal/ vulvovaginal products (douches, spermicidal foams or gels, vaginal lubricants, etc) from the screening visit until the follow up visit;
Exclusion Criteria
- •1\. Women will be excluded from the study if they are using or has used any topical or systemic medication, particularly antimicrobial agents over a 30\-day period prior to the start of the investigation;
- •2\. Female patient has a positive pregnancy test at screening, is pregnant or lactating, or is planning to become pregnant during the study period;
- •3\. Previously diagnosed with human immunodeficiency virus (HIV) infection, having visible vaginal or cervical mass suspected cancer, and within six weeks of post\-abortion or postpartum;
- •4\. Women who are currently or who will require treatment with anticoagulants, lithium, disulfiram, or neuromuscular blocking agents;
- •5\. Women are hypersensitive to clindamycin, clotrimazole or to any excipient in the drug formulation;
- •6\. Female patients who are breastfeeding or intending to breast feed during study period;
- •7\. Study will also exclude patients with history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition;
- •8\. Patients with a history of seizure disorders;
- •9\. Patients with renal impairment (S. Creatinine \> 1\.5 times the normal reference values)
- •10\. Patients with hepatic impairment. \[SGOT, SGPT, S. Bilirubin (Total) \>1\.5 times the normal reference values;
Outcomes
Primary Outcomes
Not specified
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