ProF-001_Phase IIa

March 13, 2019 updated by: ProFem GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Medical University Innsbruck
      • Schwaz, Austria
        • Bezirkskrankenhaus Schwaz
      • Vienna, Austria
        • Medical University Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 60 minutes after application and at day 7 (± 3 days) after drug application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
overall study period (max. 65 days)
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.
within 60 minutes after drug application
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.
day 7 ±3 days after drug application
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)
day 7 ±3 days after drug application
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.
day 7 ±3 days after drug application
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.
overall study period (max. 65 days)
Time to termination of clinical symptoms
Time Frame: overall study period (max. 65 days)
The time to termination of clinical symptoms will be documented.
overall study period (max. 65 days)
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.
follow-up period (from day 8 to day 60)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProFem GmbH

Investigators

  • Principal Investigator: Herbert Kiss, Ao.Univ.Prof.Dr., Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2017

Primary Completion (Actual)

July 30, 2018

Study Completion (Actual)

July 30, 2018

Study Registration Dates

First Submitted

March 13, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProF-001_Phase IIa

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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