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Trial record 20 of 27 for:    Clotrimazole AND Fungal Infections

ProF-001_Phase IIa

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ClinicalTrials.gov Identifier: NCT03115073
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
ProFem GmbH

Tracking Information
First Submitted Date  ICMJE March 13, 2017
First Posted Date  ICMJE April 14, 2017
Last Update Posted Date March 14, 2019
Actual Study Start Date  ICMJE April 4, 2017
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
Combined outcome measure of: Symptom relief within the first 60 minutes (after application of investigational product or active control) and clinical cure at day 7 (± 3 days). [ Time Frame: within 60 minutes after application and at day 7 (± 3 days) after drug application ]
As the primary outcome symptom relief within the first 60 minutes will be documented. A reduction of the subjective symptom score ≥ 2 is expected. Furthermore clinical cure at day 7 will be documented. Clinical cure is defined as absence of signs and symptoms of VVC.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03115073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • Number of patients with local adverse events and serious adverse events (SAEs) with causal relationship to study medication [ Time Frame: overall study period (max. 65 days) ]
    All local adverse events and serious adverse events with causal relationship to study medication (drug reaction) will be documented in a descriptive manner.
  • Symptom relief within the first 60 minutes (after application of investigational product or active control, reduction of the subjective symptom score ≥ 2) [ Time Frame: within 60 minutes after drug application ]
    Symptom relief within the first 60 minutes will be documented. A reduction of the subjective symptom score ≥ 2 is expected.
  • Clinical cure (absence of signs and symptoms of VVC) at the TOC visit (=day 7/ accepted time window ±3days) [ Time Frame: day 7 ±3 days after drug application ]
    Clinical cure at day 7 will be documented. Clinical cure is defined as absence of signs and symptoms of VVC.
  • Mycological outcome: Vaginal swab culture negative for growth of Candida albicans and/or Candida species at the TOC visit (day 7 / ±3days) [ Time Frame: day 7 ±3 days after drug application ]
    A vaginal swab culture will be taken on day 7 / ±3days. The test result is expected to be negative for growth of Candida albicans and/or Candida species.visit (day 7 / ±3days)
  • Responder outcome: absence of signs and symptoms plus vaginal swab culture negative for growth of Candida albicans and/or Candida species at the TOC visit (day 7 / ±3days) [ Time Frame: day 7 ±3 days after drug application ]
    Presence or absence of signs and symptoms will be documented. Vaginal swab culture is expected to be negative for growth of Candida albicans and/or Candida species at the TOC visit.
  • Time to improvement of symptoms after first intervention [ Time Frame: overall study period (max. 65 days) ]
    The time to improvement of symptoms after the first intervention will be documented.
  • Time to termination of clinical symptoms [ Time Frame: overall study period (max. 65 days) ]
    The time to termination of clinical symptoms will be documented.
  • Clinical relapse of VVC during follow-up period [ Time Frame: follow-up period (from day 8 to day 60) ]
    Every clinical relapse of VVC during the follow-up period will be documented.
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 ProF-001_Phase IIa
Official Title  ICMJE A Phase IIa Randomized, Active-controlled, Double-blind, Dose-escalation Study in Patients With Vulvovaginal Candidiasis to Evaluate Dose Response Relationship of Clinical Efficacy, Safety and Tolerability of Topically Administered ProF-001
Brief Summary

This is a multi-center, randomized, prospective, active-controlled, double-blind, dose-escalation study comparing dose response of clinical efficacy, safety, local tolerability of three different doses of ProF-001/Candiplus® (Candiplus® 0.2%, Candiplus® with 0.3%, Candiplus® with 0.4%) to 1% clotrimazole vaginal cream.

Patients with acute episode of vulvovaginal candidiasis (VVC) will be randomized to receive a daily dose of either 5 ml (intravaginal) of Candiplus® at three different doses for the first 3 days and 2.5 ml for the remaining 3 days or 5 ml (intravaginal) application of 1% clotrimazole cream over the first 3 days and 2.5 ml for the remaining 3 days according to the following scheme (with each application 2 cm of cream will be applied to the vulvar region):

Cohort 1: Candiplus® 0.2% versus clotrimazole mono Cohort 2: Candiplus® 0.3% versus clotrimazole mono Cohort 3: Candiplus® 0.4% versus clotrimazole mono Randomization into the cohorts will occur consecutively from the lowest dose to the highest dose, i.e. patients will be randomized first in cohort 1 and finally in cohort 3.

The proposed study is - after a pilot study to assess critical pharmacokinetic data - the second study within a clinical trial program with the objective to develop a new combination therapy for the treatment of vulvovaginal candidiasis.

The new combination consists of two registered drug substances.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Vulvovaginal Candidiasis (VVC)
Intervention  ICMJE
  • Drug: Candiplus
    Administration of Candiplus
  • Drug: Clotrimazole
    Administration of Clotrimazole
Study Arms  ICMJE
  • Experimental: 0,2% Candiplus
    Candiplus® 0.2%
    Intervention: Drug: Candiplus
  • Experimental: 0,3% Candiplus
    Candiplus® 0.3%
    Intervention: Drug: Candiplus
  • Experimental: 0,4% Candiplus
    Candiplus® 0.4%
    Intervention: Drug: Candiplus
  • Active Comparator: Clotri mono
    Clotrimazole mono
    Intervention: Drug: Clotrimazole
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2017)
84
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 30, 2018
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Premenopausal female patients ≥ 18 years old
  • Patients suffering from an acute episode of vulvovaginal candidiasis, characterized by:

    • Positive vaginal smear (native, KOH) for budding yeasts and/or fungal (pseudo-) hyphae, normal or intermediate flora (G I and G II)
    • Positive clinical symptoms (itching, burning, irritation, edema, erythema, excoriations), with a subjective symptom score of at least 3 (0=absent, 1=mild, 2=moderate, and 3=severe), with score being at least moderate for at least 1 subjective symptom and itching being present, and a total sign and symptom score of at least 4
  • Readiness for sexual abstinence from start of treatment until test of cure (TOC) - visit
  • Sufficient knowledge of German language to understand trial instructions and rating scales, and ability to comply with treatment
  • Written informed consent prior to enrolment

Exclusion Criteria:

  • Known hypersensitivity to any ingredient of the investigational medicinal product
  • Pregnancy or breast feeding at time of screening
  • Menstrual bleeding (spotting is not an exclusion criterion) during the first three days of treatment
  • Acute cystitis
  • Patients with clinical signs of other infectious causes of vulvovaginitis: bacterial vaginosis (GIII), trichomonas vaginalis, herpes simplex genitalis
  • Treatment with antimycotics (systemic or vaginal) within 7 days of randomization
  • Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
  • Patients with other clinical gynecological abnormalities, such as infections of the upper urogenital tract (pelvic inflammatory disease, adnexitis)
  • Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response (e.g. Lichen sclerosus, neuropathic pain)
  • Subjects who will be under treatment or surgery for gynecological pathologies during the study period, i.e, cervical intraepithelial neoplasia, cervical carcinoma, other neoplasms
  • Known alcohol, drug or medication abuse
  • Any clinically relevant concomitant condition that could compromise the objectives of this study and/ or the patient's compliance (eg. known immune deficiency syndrome with clinical relevance at time of screening)
  • Participation in another interventional clinical trial within the last 30 days
  • Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
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 Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03115073
Other Study ID Numbers  ICMJE ProF-001_Phase IIa
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 Not Provided
Responsible Party ProFem GmbH
Study Sponsor  ICMJE ProFem GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Herbert Kiss, Ao.Univ.Prof.Dr. Medical University of Vienna
PRS Account ProFem GmbH
Verification Date September 2017

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