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

Last updated: March 6, 2019
Sponsor: Medinova AG
Overall Status: Trial Not Available

Phase

3

Condition

Sexually Transmitted Diseases (Stds)

Candidemia/candidiasis

Systemic Fungal Infections

Treatment

N/A

Clinical Study ID

NCT02907307
LacS011
  • Ages > 18
  • Female

Study 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)

Eligibility Criteria

Inclusion

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).

  1. Direct microscopy (Wet smear) positive for yeast forms (hyphae, pseudohyphae) orbudding yeasts

  2. Normal vaginal pH (≤4.5)

  3. Age: 18 years and older

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

Exclusion

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 andother 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 oralcontraceptive or not having an IUD for contraception

  • Woman using intravaginal pessaries, rings, sponges or diaphragms

  • Severe systemic diseases (diabetes mellitus, cancer, tuberculosis, autoimmunediseases, 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 theirexcipients.

  • Participation of patient in another clinical study concomitantly or within 30 daysprior to enrolment

  • Patient is relative of, or staff directly reporting to, the investigator.

Study Design

Study Start date:
December 01, 2018
Estimated Completion Date:
July 31, 2020

Study 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.