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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Recruitment Status : Withdrawn (Development project stopped)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

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)

Condition or disease Intervention/treatment Phase
Vulvovaginal Candidiasis Device: LactiSal vaginal gel 1% Device: LactiSal vaginal tablet 50mg Drug: Clotrimazole vaginal tablet 100mg Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: LactiSal vaginal gel 1%
5g of 1%LactiSal Gel vaginal gel once daily for 6 days
Device: LactiSal vaginal gel 1%
to be administered daily intravaginally for 6 days

Experimental: LactiSal vaginal tablet 50 mg
50 mg of LactiSal vaginal tablet daily for 6 days
Device: LactiSal vaginal tablet 50mg
to be administered daily intravaginally for 6 days

Active Comparator: Clotrimazole vaginal tablet 100mg
100 mg Clotrimazole vaginal tablet daily for 6 days
Drug: Clotrimazole vaginal tablet 100mg
to be administered daily intravaginally for 6 days
Other Name: Candibene




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Microbiological cure rate [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Negative for Candida in microscopy and culture

  3. Therapeutic cure rate [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Clinically and microbiologically cure combined

  4. 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)

  5. 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)

  6. 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

  7. pH [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Mean vaginal pH in comparison to visit E

  8. 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

  9. Efficacy assessment [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Global assessment of efficacy by patient and investigator

  10. Patients diary [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
    Assessment clinical symptoms from patient?s diary

  11. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907307


Sponsors and Collaborators
Medinova AG
Investigators
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Principal Investigator: Michael Halaška, MD Nemocnice Bulovka, 1. LF UK

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Responsible Party: Medinova AG
ClinicalTrials.gov Identifier: NCT02907307     History of Changes
Other Study ID Numbers: LacS011
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medinova AG:
LactiSal
Vaginal therapy
Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Clotrimazole
Anti-Infective Agents, Local
Anti-Infective Agents
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs