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

Medinova

Status and phase: Withdrawn; Phase 3

Conditions: Vulvovaginal Candidiasis

Treatments: Device: LactiSal vaginal gel 1%; Drug: Clotrimazole vaginal tablet 100mg; Device: LactiSal vaginal tablet 50mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02907307

LacS011

Details and patient eligibility

About

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)

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 3 patient groups

LactiSal vaginal gel 1%

Experimental group

Description:

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

Treatment:

Device: LactiSal vaginal gel 1%

LactiSal vaginal tablet 50 mg

Experimental group

Description:

50 mg of LactiSal vaginal tablet daily for 6 days

Treatment:

Device: LactiSal vaginal tablet 50mg

Clotrimazole vaginal tablet 100mg

Active Comparator group

Description:

100 mg Clotrimazole vaginal tablet daily for 6 days

Treatment:

Drug: Clotrimazole vaginal tablet 100mg