Recurrent Vulvovaginal Candidiasis Clinical Trial
Official title:
Phase IIb/III Parallel-arm, Random., Active-controlled, Double-blind, Double-dummy, Multicenter, Non-inferiority Study in Patients With RVVC to Compare Efficacy, Safety and Tolerability of Topically Administered ProF-001 to Oral Fluconazole
Verified date | September 2022 |
Source | ProFem GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective, randomized, multi-center, active-controlled, double-blind, double-dummy, multicenter, non-inferiority study comparing the clinical efficacy, safety and tolerability of ProF-001 to fluconazole.
Status | Active, not recruiting |
Enrollment | 432 |
Est. completion date | December 30, 2022 |
Est. primary completion date | November 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Female patients = 18 years - Patients suffering from an acute episode in RVVC, characterized by: - Positive vaginal smear (native or KOH) for budding yeasts and/or (pseudo-) hyphae, normal or intermediate flora - 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). - 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 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, 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 3 days of randomization or during study period other than IMP (investigational medicinal product) - Chronic (daily) use of non-steroidal anti-inflammatory medication during induction and maintenance period (>4 weeks) - 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. - Vaginal use of antihistaminic drugs during induction period - Patients receiving anti-estrogen treatment for breast cancer, patients receiving immunosuppressive drugs - Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption." - Active malignancy (except non-melanoma skin cancer, or carcinoma in situ of cervix) or current treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy, hormone therapy for cancer treatment, targeted therapy or gene therapy) - 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, known acquired immune deficiency syndrome, patients with chronic kidney disease on dialysis, patients with severe pulmonary (requiring home oxygen, uncontrolled COPD (chronic obstructive pulmonary disease) 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Ordination Dr. Fischer | Bregenz | Vorarlberg |
Austria | Ordination Dr. Nehoda | Innsbruck | Tirol |
Austria | Ordination Dr. Peter Brock | Innsbruck | Tyrol |
Austria | Universitätsklinik für Gynäkologie und Geburthilfe, Uni-Klinik IBK | Innsbruck | Tirol |
Austria | Ordination Dr. Mayr | Kufstein | Tirol |
Austria | Ambulatorium für Pilzinfektionen und andere infektiöse venero-dermatologische Erkrankungen | Wien | |
Austria | Universitätsklinik für Frauenheilkunde, AKH | Wien | |
Poland | CMR | Katowice | |
Poland | Provita Sp. z o.o. Fabryczna 13 D | Katowice | |
Poland | Centrum Zdrowia Kobiety Komed, | Kielce | |
Poland | Komed | Kielce | |
Poland | PZS Olesnica | Olesnica | |
Poland | Fem-Med | Poznan | |
Poland | Gaja Poradnie Lekarskie | Poznan | |
Poland | Bonus 2001 Sp. z o.o. Sp. K. | Skórzewo | |
Poland | Gabinety Lekarskie SIGNUM | Skórzewo | |
Poland | DC-MED., Dworcowa 5 | Swidnica | |
Poland | Centrum medyczne Lux MED | Warsaw | |
Poland | Astimed Sp. z o.o., | Warszawa | |
Poland | Centrum Medyczne LUX MED Swidnicka 40 | Wroclaw | |
Slovakia | BESME s.r.o | Bánovce Nad Bebravou | |
Slovakia | MILLY s.r.o. | Bratislava | |
Slovakia | Gynedur s.r.o. | Dubnica Nad Váhom | |
Slovakia | MCM GYNPED s.r.o. | Dubnica Nad Váhom | |
Slovakia | Gyncentrum Nitra s.r.o. | Nitra | |
Slovakia | GYNAMA s.r.o. | Nove Mesto nad Vahom | |
Slovakia | BrenCare s.r.o | Poprad | |
Slovakia | GYNECARE s.r.o. | Púchov | |
Slovakia | Gyneka s.r.o., Privatna gynekologicko porodnicka ambulancia | Trencín |
Lead Sponsor | Collaborator |
---|---|
ProFem GmbH | Montavit Ges.m.b.H. |
Austria, Poland, Slovakia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Improvement of patient reported health related quality of life score at the end of the observation period using the EQ-5D questionnaire | Registration of changes of health related quality of life (HRQoL)- score values at 0, 6 and 12 months | 0, 6 and12 months | |
Other | Sexual function related to pain and improvement thereof (see Annex I) | Evaluation of sexual function by changes of score values in a questionnaire regarding sexual function after 0, 6 and 12 months | 0, 6 and12 months | |
Primary | Percentage of patients with at least one episode of clinical relapse of VVC during the 12 months study period. | Registration of the number of patients with a clinical relapse within 12 months after randomization, clinical relapse of VVC is defined as severity score of VVC grade = 3 with positive vaginal smear (native or KOH) with budding yeast or hyphae) | after 12 months | |
Secondary | Proportion of patients with clinical cure (absence of signs and symptoms of VVC) at 6, 8, 10 and 12 months after randomization | Registration of the number of clinically cured patients throughout the study period by determination of severity score values. | 6, 8, 10, 12 months | |
Secondary | Percentage of patients with clinical cure (defined as absence of signs and symptoms of VVC) at the test of cure visit, day 10 (+ 4 days) | Registration of patients with a severity score value of 0 after therapy of the acute phase at TOC visit | after 2 weeks | |
Secondary | Patient reported outcome of time to termination of clinical symptoms using the 11-point numeric rating scale (NRS) for burning, itching, soreness/irritation | Registration of duration of the acute episode by decrease of NRS values in a self-assessment tool, reported in a paper diary or an electronic patient reported outcome (ePRO) system | within 2 weeks after randomization | |
Secondary | Symptom relief reported by patients within the first 6 to 12 hours and following day after first application. Symptom relief as improvement of = 2 points of symptoms compared to pre-treatment in the NRS. | Registration of rapid pain release by a patient reported outcome tool by measuring the decrease of NRS values for burning, itching, soreness/irritation | 48 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05074602 -
A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis
|
Phase 3 | |
Completed |
NCT04029116 -
Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
|
Phase 3 | |
Completed |
NCT01067131 -
Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection
|
Phase 1 | |
Completed |
NCT03840616 -
Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
|
Phase 3 | |
Recruiting |
NCT04699240 -
Study of Lactobacillus in Adjuvant Treatment of RVVC
|
Phase 4 | |
Not yet recruiting |
NCT04639544 -
Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis
|
N/A | |
Completed |
NCT02267382 -
A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
|
Phase 2 | |
Recruiting |
NCT06190509 -
Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women With Recurrent Vulvovaginal Candidiasis: A Randomized Controlled Study
|
Phase 1/Phase 2 | |
Completed |
NCT03561701 -
A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
|
Phase 3 | |
Completed |
NCT03562156 -
A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
|
Phase 3 | |
Completed |
NCT05795491 -
Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis
|
N/A | |
Completed |
NCT03059992 -
Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment
|
Phase 3 |