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

NCT ID: NCT02907307

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-31
• Study Completion Date: 2020-07-31

Brief 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)

Detailed Description

National multicenter,randomized, open-label, active-controlled with three parallel groups.Eligible patients are randomized to receive LactiSal 1% vaginal gel, LactiSal 50 mg vaginal tablet or clotrimazole 100 mg vaginal tablet for 6 days. Control examaminations are performed 10 after entry and 4 weeks after control visit 1.

The study investigates the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50mg vaginal tablets in the intended use, i.e. vaginal application, and the following intended claims:

• Treatment of vaginal yeast vaginitis
• Relieves vaginal itching, burning, redness and discharge in case of yeast vaginitis
• Inhibition of yeast colonization in the vagina in case of yeast vaginitis. The study is designed to compare the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50 mg vaginal tablets to a current standard drug therapy, i.e. clotrimazole 100 mg vaginal tablets.

While LactiSal is classified as medical device class IIa, the comparator is a medicinal (pharmaceutical) product. The study represents a "mixed" study, comparing the efficacy of a medical device with a pharmaceutical product.

Conditions

Vulvovaginal Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LactiSal vaginal gel 1%

5g of 1%LactiSal Gel vaginal gel once daily for 6 days

Group Type: EXPERIMENTAL

LactiSal vaginal gel 1%

Intervention Type: DEVICE

to be administered daily intravaginally for 6 days

LactiSal vaginal tablet 50 mg

50 mg of LactiSal vaginal tablet daily for 6 days

Group Type: EXPERIMENTAL

LactiSal vaginal tablet 50mg

Intervention Type: DEVICE

to be administered daily intravaginally for 6 days

Clotrimazole vaginal tablet 100mg

100 mg Clotrimazole vaginal tablet daily for 6 days

Group Type: ACTIVE_COMPARATOR

Clotrimazole vaginal tablet 100mg

Intervention Type: DRUG

to be administered daily intravaginally for 6 days

Interventions

LactiSal vaginal gel 1%

to be administered daily intravaginally for 6 days

Intervention Type: DEVICE

LactiSal vaginal tablet 50mg

to be administered daily intravaginally for 6 days

Intervention Type: DEVICE

Clotrimazole vaginal tablet 100mg

to be administered daily intravaginally for 6 days

Intervention Type: DRUG

Other Intervention Names

Candibene

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medinova AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Halaška, MD

Role: PRINCIPAL_INVESTIGATOR

Nemocnice Bulovka, 1. LF UK

Other Identifiers

LacS011

Identifier Type: -

Identifier Source: org_study_id