The purpose of this study is to compare the efficacy and safety of LactiSal 1%vaginal gel and
LactiSal 50 mg vaginal tablet with the standart treatment of clotrimazole 100 mg vaginal
tablet in woman with vulvovaginal candidiasis (VVC)
Device: LactiSal vaginal gel 1%
Device: LactiSal vaginal tablet 50mg
Drug: Clotrimazole vaginal tablet 100mg
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Full eligibility criteria for NCT02907307
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Clinical signs & symptoms of VVC as Total Severity Score, TSC 4 (range 0-15):
vaginal itching (range 0-3) ,
vaginal burning or soreness (range 0-3),
abnormal vaginal discharge (range 0-3),
vulvo/vaginal erythema or oedema (range 0-3),
vulvar excoriation or fissure formation (range 0-3).
Direct microscopy (Wet smear) positive for yeast forms (hyphae, pseudohyphae) or budding yeasts
Normal vaginal pH (≤4.5)
Age: 18 years and older
Signed Written Informed Consent to participate in this study.
Recurrent VVC (4 episodes of VVC in the past 12 months).
Women with other vaginal infections, e.g. bacterial vaginosis, aerobic vaginitis, trichomoniasis, and mixed infections.
Women using oral or vaginal antifungals within 2 weeks prior to enrolment.
Women using any intra-vaginal products, also vaginal douches containing soaps and other anionic, surface-active substances, within 2 weeks prior to enrolment.
Women using any antibiotic or anti-infective within 2 weeks prior to enrolment.
Women having menstruation bleeding at enrolment
Cervicitis, cervical erosions, and malignant tumours in the genital tract
Pregnancy or lactation.
Women not consenting to be sexually abstinent during the treatment, not taking oral contraceptive or not having an IUD for contraception
Woman using intravaginal pessaries, rings, sponges or diaphragms
Severe systemic diseases (diabetes mellitus, cancer, tuberculosis, autoimmune diseases, severe psychiatric conditions, etc.).
Women with confirmed or suspected STD (HIV infection, gonorrhoea, syphilis, chlamydiasis, etc.).
Known or suspected hypersensitivity to one of the study medications, inclusive their excipients.
Participation of patient in another clinical study concomitantly or within 30 days prior to enrolment
Patient is relative of, or staff directly reporting to, the investigator.
All locations for NCT02907307
View full eligibility
Tris trial is registered with FDA with number: NCT02907307. The sponsor of the trial is Medinova AG and it is looking for 0 volunteers for the current phase.
Official trial title: Comparative Study of the Efficacy and Safety of LactiSal 1% Vaginal Gel and LactSal 50 mg Vaginal Tablet Versus Clotrimazole 100 mg Vaginal Tablet in the Treatment of Vulvovaginal Candidiasis (VVC)
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