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ProF-001_Phase IIa

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ClinicalTrials.gov Identifier: NCT03115073
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
ProFem GmbH

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.


Condition or disease Intervention/treatment Phase
Vulvovaginal Candidiasis (VVC) Drug: Candiplus Drug: Clotrimazole Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: 0,2% Candiplus
Candiplus® 0.2%
Drug: Candiplus
Administration of Candiplus

Experimental: 0,3% Candiplus
Candiplus® 0.3%
Drug: Candiplus
Administration of Candiplus

Experimental: 0,4% Candiplus
Candiplus® 0.4%
Drug: Candiplus
Administration of Candiplus

Active Comparator: Clotri mono
Clotrimazole mono
Drug: Clotrimazole
Administration of Clotrimazole




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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.

  6. 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.

  7. Time to termination of clinical symptoms [ Time Frame: overall study period (max. 65 days) ]
    The time to termination of clinical symptoms will be documented.

  8. 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.



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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:

  • 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

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): NCT03115073


Contacts
Contact: Marion Noe-Letschnig, DI DDr. +43 676 7203070 marion.noe@profem.at

Locations
Austria
Medical University Innsbruck Recruiting
Innsbruck, Austria
Bezirkskrankenhaus Schwaz Recruiting
Schwaz, Austria
Medical University Vienna Recruiting
Vienna, Austria
Sponsors and Collaborators
ProFem GmbH
Investigators
Principal Investigator: Herbert Kiss, Ao.Univ.Prof.Dr. Medical University of Vienna

Additional Information:
Publications:

Responsible Party: ProFem GmbH
ClinicalTrials.gov Identifier: NCT03115073     History of Changes
Other Study ID Numbers: ProF-001_Phase IIa
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ProFem GmbH:
Vulvovaginal candidiasis
Candiplus
Clotrimazole
Safety
Tolerability
Clinical efficacy

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases