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

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Primary Purpose

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

LactiSal vaginal gel 1%

LactiSal vaginal tablet 50mg

Clotrimazole vaginal tablet 100mg

About this trial

This is an interventional treatment trial for Vulvovaginal Candidiasis focused on measuring LactiSal, Vaginal therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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).
Direct microscopy (Wet smear) positive for yeast forms (hyphae, pseudohyphae) or budding yeasts
Normal vaginal pH (≤4.5)
Age: 18 years and older
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

LactiSal vaginal gel 1%

LactiSal vaginal tablet 50 mg

Clotrimazole vaginal tablet 100mg

Arm Description

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

50 mg of LactiSal vaginal tablet daily for 6 days

100 mg Clotrimazole vaginal tablet daily for 6 days

Outcomes

Primary Outcome Measures

Clinical cure rate

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 Outcome Measures

Clinical cure rate

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.

Microbiological cure rate

Negative for Candida in microscopy and culture

Therapeutic cure rate

Clinically and microbiologically cure combined

The Total Severity Score (TSC) Individual clinical signs and symptoms

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

Presence of dyspareunia and external dysuria (yes/no)

Direct microscopy (Wet smear)

Number of positive findings in Direct microscopy (Wet smear) in comparison to visit E

pH

Mean vaginal pH in comparison to visit E

Candida culture

Number of positive Candida cultures in comparison to visit E

Efficacy assessment

Global assessment of efficacy by patient and investigator

Patients diary

Assessment clinical symptoms from patient?s diary

Patient's satisfaction

Patient will be asked how satisfied she was with the treatment received based on 8 standardized questions.

Full Information

NCT ID

NCT02907307

First Posted

September 23, 2015

Last Updated

March 6, 2019

Sponsor

Medinova AG

1. Study Identification

Unique Protocol Identification Number

NCT02907307

Brief Title

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

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Development project stopped

Study Start Date

December 2018 (Anticipated)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medinova AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vulvovaginal Candidiasis

Keywords

LactiSal, Vaginal therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LactiSal vaginal gel 1%

Arm Type

Experimental

Arm Description

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

Arm Title

LactiSal vaginal tablet 50 mg

Arm Type

Experimental

Arm Description

50 mg of LactiSal vaginal tablet daily for 6 days

Arm Title

Clotrimazole vaginal tablet 100mg

Arm Type

Active Comparator

Arm Description

100 mg Clotrimazole vaginal tablet daily for 6 days

Intervention Type

Device

Intervention Name(s)

LactiSal vaginal gel 1%

Intervention Description

to be administered daily intravaginally for 6 days

Intervention Type

Device

Intervention Name(s)

LactiSal vaginal tablet 50mg

Intervention Description

to be administered daily intravaginally for 6 days

Intervention Type

Drug

Intervention Name(s)

Clotrimazole vaginal tablet 100mg

Other Intervention Name(s)

Candibene

Intervention Description

to be administered daily intravaginally for 6 days

Primary Outcome Measure Information:

Title

Clinical cure rate

Description

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.

Time Frame

10 days after entry (C1)

Secondary Outcome Measure Information:

Title

Clinical cure rate

Description

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.

Time Frame

4 weeks after control visit 1

Title

Microbiological cure rate

Description

Negative for Candida in microscopy and culture

Time Frame