A phase IIa clinical trial in patients with vaginal mycosis to evaluate clinical efficacy, safety and tolerability and dose response relationship of topically administered ProF-001.

Phase 1

Conditions: Vulvovaginal candidiasis
MedDRA version: 20.1Level: PTClassification code 10047784Term: Vulvovaginal candidiasisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2016-004268-21-AT

Lead Sponsor: Profem GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

1.Premenopausal female patients = 18 years old
2.Patients suffering from an acute episode of vulvovaginal candidiasis, characterized by:
•Positive vaginal smear (native or KOH) for budding yeasts and/or fungal (pseudo-)hyphae, normal (G I) or intermediate flora (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
3.Readiness for sexual abstinence from start of treatment until test of cure (TOC) visit
4.Ability to understand trial instructions and rating scales as well as ability to comply with treatment
5.Written informed consent prior to enrolment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known hypersensitivity to clotrimazole, diclofenac or any other ingredient of the investigational medicinal product
2.Pregnancy or breast feeding at time of screening
3.Menstrual bleeding (spotting is not an exclusion criterion) during the first three days of treatment
4.Acute cystitis
5.Patients with clinical signs of other infectious causes of vulvovaginitis: bacterial vaginosis (GIII), trichomonas vaginalis, herpes simplex genitalis
6.Treatment with antimycotics (systemic or vaginal) within 7 days of randomization
7.Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
8.Patients with other clinical gynecological abnormalities, such as infections of the upper urogenital tract (pelvic inflammatory disease, adnexitis)
9.Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response (e.g. Lichen sclerosus, neuropathic pain)
10.Subjects who will be undergoing treatment or surgery for gynecological pathologies during the study period, i.e, cervical intraepithelial neoplasia, cervical carcinoma, other neoplasms
11.Known alcohol, drug or medication abuse
12.Any clinically relevant concomitant condition that could compromise the objectives of this study and/ or the patient’s compliance (e.g. known immune deficiency syndrome with clinical relevance at time of screening)
13.Participation in another interventional clinical trial within the last 30 days
14.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 & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine dose-response in clinical efficacy of multiple dose administration of ProF-001 after vaginal administration at three dose levels compared to 1% vaginal clotrimazole cream;Secondary Objective: - To evaluate safety and tolerability of ProF-001<br>- To generate data on additional clinical and surrogate endpoints;Primary end point(s): Dose response relationship of the combined primary clinical efficacy endpoint:<br>1. Symptom relief within the first 60 minutes (after application of investigational product or active control, reduction of the subjective symptom score = 2) and <br>2. Clinical cure (absence of signs and symptoms of VVC) at day 7 (± 3 days).;Timepoint(s) of evaluation of this end point: 60 minutes after first application of IMP; at day 7

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Number of patients with local adverse events and serious adverse events with causal relationship to study medication<br>- Symptom relief within the first 60 minutes (after application of investigational product or active control, reduction of the subjective symptom score = 2) <br>- Clinical cure (absence of signs and symptoms of VVC) at the TOC visit <br>- Mycological outcome: Vaginal swab culture negative for growth of Candida albicans at the TOC visit (day 7 / ±3days)<br>- Responder outcome: absence of signs and symptoms plus vaginal swab culture negative for growth of Candida albicans at the TOC visit (day 7 / ±3days)<br>- Time to improvement of symptoms after first intervention<br>- Time to termination of clinical symptoms <br>- Clinical relapse of VVC during follow-up period;Timepoint(s) of evaluation of this end point: Active treatment period and follow-up period