ProF-001_Phase IIa

Launched by PROFEM GMBH · Apr 10, 2017

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility 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