Vulvovaginal Candidiasis
Conditions
Keywords
LactiSal, Vaginal therapy
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.
Interventions
DEVICELactiSal vaginal gel 1%
to be administered daily intravaginally for 6 days
DEVICELactiSal vaginal tablet 50mg
to be administered daily intravaginally for 6 days
DRUGClotrimazole vaginal tablet 100mg
to be administered daily intravaginally for 6 days
Sponsors
Medinova AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical cure rate | 10 days after entry (C1) | Clinical cure is defined as patient having a Total Severity Score of less than 3. The Total Severity Score (TSC) is assessed by the Investigator, examining and interviewing the patient. The TSC is the sum score of the 5 individual signs symptoms - vaginal itching, vaginal burning or soreness, abnormal vaginal discharge, vulvovaginal erythema or oedema and vulval excoriation or fissure formation. Each sign and symptom is assessed with a score from 0 to 3, resulting in total score for TSC of 0 to 15. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological cure rate | 10 days after entry visit and 4 weeks after control visit 1 | Negative for Candida in microscopy and culture |
| Therapeutic cure rate | 10 days after entry visit and 4 weeks after control visit 1 | Clinically and microbiologically cure combined |
| The Total Severity Score (TSC) Individual clinical signs and symptoms | 10 days after entry visit and 4 weeks after control visit 1 | The TCS assessed by the investigator * 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) |
| Dyspareunia and external dysuria | 10 days after entry visit and 4 weeks after control visit 1 | Presence of dyspareunia and external dysuria (yes/no) |
| Direct microscopy (Wet smear) | 10 days after entry visit and 4 weeks after control visit 1 | Number of positive findings in Direct microscopy (Wet smear) in comparison to visit E |
| Clinical cure rate | 4 weeks after control visit 1 | Clinical cure is defined as patient having a Total Severity Score of less than 3. The Total Severity Score (TSC) is assessed by the Investigator, examining and interviewing the patient. The TSC is the sum score of the 5 individual signs symptoms - vaginal itching, vaginal burning or soreness, abnormal vaginal discharge, vulvovaginal erythema or oedema and vulval excoriation or fissure formation. Each sign and symptom is assessed with a score from 0 to 3, resulting in total score for TSC of 0 to 15. |
| Candida culture | 10 days after entry visit and 4 weeks after control visit 1 | Number of positive Candida cultures in comparison to visit E |
| Efficacy assessment | 10 days after entry visit and 4 weeks after control visit 1 | Global assessment of efficacy by patient and investigator |
| Patients diary | 10 days after entry visit and 4 weeks after control visit 1 | Assessment clinical symptoms from patient?s diary |
| Patient's satisfaction | 10 days after entry visit and 4 weeks after control visit 1 | Patient will be asked how satisfied she was with the treatment received based on 8 standardized questions. |
| pH | 10 days after entry visit and 4 weeks after control visit 1 | Mean vaginal pH in comparison to visit E |
Outcome results
None listed