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NCT Number: NCT03115073

ProF-001_Phase IIa

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.

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Key information

Conditions

Vulvovaginal Candidiasis (VVC) Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Medical University Innsbruck, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Candiplus

Drug

Administration of Candiplus

clotrimazole

Drug

Administration of Clotrimazole

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

ProFem GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2017
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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