Efficacy, Safety LactiSal 1% Gel, LactSal 50 mg, Clotrimazole 100 mg Tablet in Treatment Vulvovaginal Candidiasis

• Status: Withdrawn
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medinova AG
• Treatments: Clotrimazole; Miconazole

Criteria

Inclusion Criteria:

1. 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).

2. Direct microscopy (Wet smear) positive for yeast forms (hyphae, pseudohyphae) or budding yeasts

3. Normal vaginal pH (≤4.5)

4. Age: 18 years and older

5. Signed Written Informed Consent to participate in this study.

Exclusion Criteria:

• 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.