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Trial record 17 of 28 for:    Clotrimazole AND Fungal Infections

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02907307
Recruitment Status : Withdrawn (Development project stopped)
First Posted : September 20, 2016
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Medinova AG

Tracking Information
First Submitted Date  ICMJE September 23, 2015
First Posted Date  ICMJE September 20, 2016
Last Update Posted Date March 8, 2019
Estimated Study Start Date  ICMJE December 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
Clinical cure rate [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
  • Clinical cure rate [ Time Frame: 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.
  • Microbiological cure rate [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Negative for Candida in microscopy and culture
  • Therapeutic cure rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Presence of dyspareunia and external dysuria (yes/no)
  • Direct microscopy (Wet smear) [ Time Frame: 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
  • pH [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Mean vaginal pH in comparison to visit E
  • Candida culture [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Number of positive Candida cultures in comparison to visit E
  • Efficacy assessment [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Global assessment of efficacy by patient and investigator
  • Patients diary [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Assessment clinical symptoms from patient?s diary
  • Patient's satisfaction [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety LactiSal 1% Gel, LactSal 50 mg, Clotrimazole 100 mg Tablet in Treatment Vulvovaginal Candidiasis
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vulvovaginal Candidiasis
Intervention  ICMJE
  • Device: LactiSal vaginal gel 1%
    to be administered daily intravaginally for 6 days
  • Device: LactiSal vaginal tablet 50mg
    to be administered daily intravaginally for 6 days
  • Drug: Clotrimazole vaginal tablet 100mg
    to be administered daily intravaginally for 6 days
    Other Name: Candibene
Study Arms  ICMJE
  • Experimental: LactiSal vaginal gel 1%
    5g of 1%LactiSal Gel vaginal gel once daily for 6 days
    Intervention: Device: LactiSal vaginal gel 1%
  • Experimental: LactiSal vaginal tablet 50 mg
    50 mg of LactiSal vaginal tablet daily for 6 days
    Intervention: Device: LactiSal vaginal tablet 50mg
  • Active Comparator: Clotrimazole vaginal tablet 100mg
    100 mg Clotrimazole vaginal tablet daily for 6 days
    Intervention: Drug: Clotrimazole vaginal tablet 100mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 6, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2016)
300
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02907307
Other Study ID Numbers  ICMJE LacS011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Medinova AG
Study Sponsor  ICMJE Medinova AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Halaška, MD Nemocnice Bulovka, 1. LF UK
PRS Account Medinova AG
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP