Clinical trial NCT02907307: Efficacy, Safety LactiSal 1% Gel, LactSal 50 mg, Clotrimazole 100 mg Tablet in Treatment Vulvovaginal Candidiasis
Official 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Vulvovaginal Candidiasis
Keywords: LactiSal
Vaginal therapy
Lead sponsor: Medinova AG
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical cure rate
timeFrame: 10 days after entry (C1)
Secondary outcomes:
measure: Clinical cure rate
timeFrame: 4 weeks after control visit 1
measure: Microbiological cure rate
timeFrame: 10 days after entry visit and 4 weeks after control visit 1
measure: Therapeutic cure rate
timeFrame: 10 days after entry visit and 4 weeks after control visit 1
measure: The Total Severity Score (TSC) Individual clinical signs and symptoms
timeFrame: 10 days after entry visit and 4 weeks after control visit 1
measure: Dyspareunia and external dysuria
timeFrame: 10 days after entry visit and 4 weeks after control visit 1
measure: Direct microscopy (Wet smear)
timeFrame: 10 days after entry visit and 4 weeks after control visit 1
measure: pH
timeFrame: 10 days after entry visit and 4 weeks after control visit 1
measure: Candida culture
timeFrame: 10 days after entry visit and 4 weeks after control visit 1
measure: Efficacy assessment
timeFrame: 10 days after entry visit and 4 weeks after control visit 1
measure: Patients diary
timeFrame: 10 days after entry visit and 4 weeks after control visit 1
measure: Patient's satisfaction
timeFrame: 10 days after entry visit and 4 weeks after control visit 1
Other outcomes:
Locations:
Study officials:
affiliation: Nemocnice Bulovka, 1. LF UK
name: Michael Halaška, MD
role: PRINCIPAL_INVESTIGATOR
References: