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

NCT02907307 | Withdrawn Phase 3 DMC

• 1 other identifier: LacS011
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Vulvovaginal Candidiasis

Keywords

LactiSal; Vaginal therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  10 days after entry (C1)

Secondary Outcomes (11)

• Clinical cure rate

  4 weeks after control visit 1

• Microbiological cure rate

  10 days after entry visit and 4 weeks after control visit 1

• Therapeutic cure rate

  10 days after entry visit and 4 weeks after control visit 1

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

  10 days after entry visit and 4 weeks after control visit 1

• Dyspareunia and external dysuria

  10 days after entry visit and 4 weeks after control visit 1

Study Arms (3)

LactiSal vaginal gel 1%

EXPERIMENTAL

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

Device: LactiSal vaginal gel 1%

LactiSal vaginal tablet 50 mg

EXPERIMENTAL

50 mg of LactiSal vaginal tablet daily for 6 days

Device: LactiSal vaginal tablet 50mg

Clotrimazole vaginal tablet 100mg

ACTIVE COMPARATOR

100 mg Clotrimazole vaginal tablet daily for 6 days

Drug: Clotrimazole vaginal tablet 100mg

Interventions

LactiSal vaginal gel 1% DEVICE

to be administered daily intravaginally for 6 days

LactiSal vaginal gel 1%

LactiSal vaginal tablet 50mg DEVICE

to be administered daily intravaginally for 6 days

LactiSal vaginal tablet 50 mg

Clotrimazole vaginal tablet 100mg DRUG

to be administered daily intravaginally for 6 days

Also known as: Candibene

Clotrimazole vaginal tablet 100mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medinova AG: lead

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Officials

• Michael Halaška, MD

  Nemocnice Bulovka, 1. LF UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 20, 2016
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: July 1, 2020
• Last Updated: March 8, 2019

Record last verified: 2017-12