recurrent vulvovaginal candidiasis MedDRA version: 20.1 Level: PT Classification code 10047784 Term: Vulvovaginal candidiasis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Candiplus
Product Code: ProF-001
Pharmaceutical Form: Vaginal cream
INN or Proposed INN: Clotrimazole
CAS Number: 23593-75-1
Current Sponsor code: 16481701
Other descriptive name: CLOTRI
Sponsors
Profem GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female patients = 18 years • Patients suffering from an acute episode in RVVC, characterized by: o Positive vaginal smear (native or KOH) for budding yeasts and/or fungal (pseudo-) hyphae, normal or intermediate flora o Two or more of the following signs and symptoms of VVC that are characterized as moderate or severe: itching, burning, irritation, edema, redness, or excoriation/fissure (Table 2). o At least 3 previous episodes of VVC during the last 12 months (i.e. at least 4 episodes including the current episode) • Readiness for sexual abstinence from start of treatment until test of cure (TOC) - visit • Ability to understand trial instructions and rating scales as well as ability to comply with treatment • 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 407 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Known hypersensitivity to clotrimazole, diclofenac, fluconazole or any other ingredient of the investigational medicinal product • Pregnancy or breast feeding at time of screening (for all females of childbearing potential, negative pregnancy test at screening and monthly during active treatment period will be performed). Females in childbearing potential must use adequate contraception during the active treatment period (sexual abstinence is an accepted method of birth control) • Menstrual bleeding (spotting is not an exclusion criterion) during the first three days of treatment during the induction period • Acute cystitis diagnosed by anamnesis and urinary dip stick (positive for leukocytes and nitrites) during screening examination • Patients with other infectious causes of vulvovaginitis assessed during gynecological examination at screening (e.g., bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex) • Patients with other clinical gynecological abnormalities, such as infections of the upper urogenital tract (pelvic inflammatory disease, adnexitis) or known high-grade cervical dysplasia at screening • Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response (e.g. lichen sclerosus, neuropathic pain, herpes zoster) • Treatment with antimycotics (systemic or vaginal) within the prior 5 days of randomization or during study period other than IMP • Chronic use of non-steroidal anti-inflammatory medication (NSAID 3 times per week or more), no NSAID within 12 hours before start of treatment allowed • Vaginal or oral antibiotic treatment during induction period • Vaginal use of corticosteroids, chronic systemic (oral, rectal or intravenous) use of corticosteroids during treatment and follow-up period (= 5 mg oral prednisolone/d or equivalent dose > 4 weeks). Topical dermal (except vulvar), intranasal or inhalative corticosteroids for allergy, asthma or chronic obstructive pulmonary disease allowed. • Use of antihistaminic drugs during induction period • Patients receiving anti-estrogen treatment for breast cancer, patients receiving immunosuppressive drugs • Known major uncontrolled medical disorder(s) that renders the subject unsuitable for participation in the study, including but not limited to: comorbid condition with an estimated life expectancy of = 12 months, patients with chronic kidney disease on dialysis, patients with severe pulmonary (requiring home oxygen, uncontrolled COPD Gold III/ IV) or cardiovascular conditions (heart failure NYHA IV) • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine clinical efficacy of ProF-001 after vaginal administration compared to oral fluconazole for the treatment and prophylaxis of RVVC;Secondary Objective: - To evaluate safety and tolerability of ProF-001 - To determine the effect of ProF-001 on clinical cure of the acute episode of VVC in RVVC - To determine clinical efficacy of maintenance therapy - To evaluate recurrence of acute episodes after treatment cessation - To evaluate treatment effect on health-related quality of life (QoL) - To evaluate treatment effect on sexual activity ;Primary end point(s): Percentage of patients with clinical relapse of VVC during a 12 months study period.;Timepoint(s) of evaluation of this end point: during active treatment period and follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of patients with adverse events and serious adverse events (SAEs) with causal relationship to study medication • Endpoints during the acute phase in RVVC: o Clinical cure (defined as absence of signs and symptoms of VVC) at the test of cure visit, day 10 (+ 4 days) o Clinical response defined as signs and symptoms 1 relapse during study period • Proportion of patients in clinical remission at 6, 8, 10 and 12 months after randomization • Improvement of patient reported health related quality of life score at the end of the observation period using the EQ-5D questionnaire • Mycological outcome: Vaginal swab culture negative for growth of Candida albicans and/or Candida species at EOT, EOS • Time to first clinical relapse during a 12 months study period (VVC-relapse is defined as clinical symptoms of VVC grade ? 3 and wet prep (Native or KOH prep) positive for fungal hyphae, pseudohyphae or budding yeasts • Number of patients with self reported relapse of VVC (symptoms of VVC = grade 3 improved with antimycotic treatment) • Sexual function using the female sexual function index (FSFI is a validated questionnaire that assesses different domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction and pain) in addition to providing an overall score regarding sexual function).;Timepoint(s) of evaluation of this end point: during active treatment period and follow-up period | — |
Countries
Austria, Germany, Poland, Russian Federation, Slovakia
Contacts
Public ContactSponsor
Profem GmbH
Outcome results
None listed