Clinical Trials Register

Summary
EudraCT Number:	2019-000925-27
Sponsor's Protocol Code Number:	ProF-001_Phase_IIb/III
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-09-09
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2019-000925-27

A.3

Full title of the trial

A phase IIb/III, parallel-arm, randomized, active-controlled, double-blind, double-dummy, multicenter, non-inferiority study in patients with recurrent vulvovaginal candidosis to compare the clinical efficacy, safety and tolerability of topically administered ProF-001 (Candiplus®) to oral fluconazole

Paralelné, randomizované, aktívne kontrolované, dvojito zaslepené, dvojito maskované, multicentrické klinické skúšanie neinferiority fázy IIb/III u pacientok s rekurentnou vulvovaginálnou kandidózou, porovnávajúce klinickú účinnosť, bezpečnosť a znášanlivosť topicky aplikovaného ProF-001 (Candiplus®) oproti perorálnemu flukonazolu

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A phase IIb/III study in patients with recurrent vaginal mycosis to compare the clinical efficacy, safety and tolerability of topically administered ProF-001 to oral fluconazole

Klinické skúšanie fázy IIb/III u pacientok s rekurentnou vaginálnou mykózou, porovnávajúce klinickú účinnosť, bezpečnosť a znášanlivosť topicky aplikovaného ProF-001 oproti perorálnemu flukonazolu

A.4.1

Sponsor's protocol code number

ProF-001_Phase_IIb/III

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Profem GmbH
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Profem GmbH
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Profem GmbH
B.5.2	Functional name of contact point	Sponsor
B.5.3	Address:
B.5.3.1	Street Address	Riglergasse 4/1
B.5.3.2	Town/ city	Vienna
B.5.3.3	Post code	1180
B.5.3.4	Country	Austria
B.5.6	E-mail	office@profem.at

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Candiplus
D.3.2	Product code	ProF-001
D.3.4	Pharmaceutical form	Vaginal cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Vaginal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Clotrimazole
D.3.9.1	CAS number	23593-75-1
D.3.9.2	Current sponsor code	16481701
D.3.9.3	Other descriptive name	CLOTRIMAZOLE
D.3.9.4	EV Substance Code	SUB06777MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diclofenac
D.3.9.1	CAS number	15307-79-6
D.3.9.2	Current sponsor code	18597201
D.3.9.3	Other descriptive name	DICLOFENAC SODIUM
D.3.9.4	EV Substance Code	SUB01674MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.3
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Fluconazol STADA 150mg capsules, hard
D.2.1.1.2	Name of the Marketing Authorisation holder	STADApharm GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Fluconazol STADA® 150 mg Hartkapseln
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fluconazole
D.3.9.1	CAS number	86386-73-4
D.3.9.2	Current sponsor code	00812573
D.3.9.3	Other descriptive name	FLUCONAZOLE
D.3.9.4	EV Substance Code	SUB07674MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Vaginal cream
D.8.4	Route of administration of the placebo	Vaginal use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

recurrent vulvovaginal candidiasis

rekurentná vulvovaginálna kandidóza

E.1.1.1

Medical condition in easily understood language

recurrent vaginal mycosis

rekurentná vaginálna mykóza

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10047784
E.1.2	Term	Vulvovaginal candidiasis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine clinical efficacy of ProF-001 after vaginal administration compared to oral fluconazole for the treatment and prophylaxis of RVVC

Stanoviť klinickú účinnosť ProF-001 po vaginálnom podaní v porovnaní s perorálnym flukonazolom na liečbu a profylaxiu RVVK

E.2.2

Secondary objectives of the trial

- 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

• Vyhodnotiť bezpečnosť a znášanlivosť ProF-001
• Stanoviť účinnosť ProF-001 na klinickú liečbu akútnej epizódy VVK pri RVVK
• Stanoviť klinickú účinnosť udržiavacej liečby
• Vyhodnotiť opakovanie akútnych epizód po ukončení liečby
• Vyhodnotiť účinok liečby na kvalitu života (QoL) súvisiacu so zdravím
• Vyhodnotiť účinok liečby na sexuálnu aktivitu

E.2.3

Trial contains a sub-study

E.3

Principal 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 (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.
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

• Pacientky ≥ 18 rokov
• Pacientky trpiace akútnou epizódou RVVK, ktorá je charakterizovaná:
o Pozitívnym vaginálnym sterom (natívny alebo KOH) na pučiace kvasinky a/alebo (pseudo-) hýfy, normálnou alebo prechodnou flórou
o Dvoma alebo viacerými z nasledujúcich príznakov a symptómov VVK, ktoré sú charakterizované ako stredne závažné alebo závažné: svrbenie, pálenie, podráždenie, edém, sčervenanie alebo exkoriácia / trhlina.
o Aspoň 3 predchádzajúce epizódy VVK počas posledných 12 mesiacov (t.j. aspoň 4 epizódy vrátane tej súčasnej)
• Pripravenosť sexuálne abstinovať od začiatku liečby až po návštevu na overenie liečby (TOC)
• Schopnosť porozumieť pokynom skúšania a hodnotiacim stupniciam ako aj schopnosť dodržiavať liečbu
• Písomný informovaný súhlas

E.4

Principal 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
•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 deficiancy 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 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

• Známa precitlivelosť na klotrimazol, diklofenak, flukonazol alebo inú zložku skúšaného lieku
• Tehotenstvo alebo dojčenie v čase skríningu (všetky ženy vo fertilnom veku absolvujú pri skríningu a raz mesačne počas aktívnej liečby tehotenský test). Ženy vo fertilnom veku musia počas aktívneho liečebného obdobia používať adekvátnu antikoncepciu (sexuálna abstinencia je akceptovateľnou metódou kontroly počatia)
• Menštruačné krvácanie (špinenie nie je exklúznym kritériom) počas prvých troch dní indukčného obdobia
• Akútna cystitída, diagnostikovaná anamnézou a prúžkovým močovým testom (pozitívny na leukocyty a nitrity) počas skríningového vyšetrenia
• Pacientky s inými infekčnými príčinami vulvovaginitídy hodnotenej počas gynekologického vyšetrenia pri skríningu ( (napr. bakteriálna vaginóza,Trichomonas vaginalis, Herpes simplex)
• Pacientky s inými klinickými gynekologickými abnormalitami, ako sú infekcie horného urogenitálneho traktu (zápalové ochorenie panvy, adnexitída) alebo známa dysplázia krčka maternice vysokého stupňa pri skríningu
• Subjekty s iným stavom vagíny alebo vulvy, ktorý by spochybnil interpretáciu klinickej odpovede (napr. Lichen sclerosus, neuropatická
bolesť, herpes zoster)
• Liečba antimykotikami (systémovými alebo vaginálnymi), inými ako skúšaný liek, počas 3 dní od randomizácie alebo počas štúdie
• Chronické (denné) užívanie nesteroidných protizápalových liekov počas indukčného a udržiavacieho obdobia (>4 týždne)
• Liečba vaginálnymi alebo orálnymi antibiotikami počas indukčného obdobia
• Používanie vaginálnych kortikosteroidov, chronických systémových (perorálnych, rektálnych alebo intravenóznych) kortikosteroidov počas liečby a sledovacieho obdobia (≥ 5 mg orálneho prednisolonu denne alebo ekvivalentná dávka > 4 týždne). Topické dermálne (okrem vulvárnych), intranasálne alebo inhalačné kortikosteroidy na alergiu, astmu alebo obštrukčnú chorobu pľúc sú povolené
• Vaginálne používanie antihistaminík počas indukčného obdobia
• Pacientky dostávajúce anti-estrogénovú liečbu rakoviny prsníka, pacientky užívajúce imunosupresívnu liečbu
• Pacientky s ojedinelými dedičnými problémami intolerancie galaktózy, nedostatočnosti Lapp-laktázy alebo malabsorpcie glukóza-galaktózy
•Aktívna malignancia (okrem nemelanómovej rakoviny kože, alebo rakoviny krčka maternice in-situ) alebo súčasná protirakovinová liečba (chemoterapia, imunoterapia, rádioterapia, hormonálna liečba rakoviny, cielená terapia alebo génová terapia )
• Známa závažná nekontrolovaná (-é) porucha (-y), ktorá spôsobuje, že subjekt nie je vhodný na účasť v skúšaní, vrátane, ale bez obmedzenia na: stav komorbidov s odhadovanou dĺžkou života ≤ 12 mesiacov, známy syndróm získanej imunitnej nedostatočnosti, pacientky s chronickým ochorením obličiek na dialýze, pacientky so závažným pľúcnym ochorením (vyžadujúcim domáci kyslík, nekontrolovaným CHOCHP Gold III / IV) alebo kardiovaskulárnymi ochoreniami (zlyhanie srdca NYHA IV)
• Účasť v inom intervenčnom klinickom skúšaní počas posledných 30 dní
• Zamestnankyňa centra klinického skúšania, manželka/partnerka alebo príbuzná niekoho zo študijného personálu (napr. skúšajúceho, spoluskúšajúceho, štúdiových sestier) alebo osoba vo vzťahu k sponzorovi

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients with at least one episode of clinical relapse of VVC during the 12 months study period.

Percentuálny podiel pacientok s aspoň jednou epizódou klinického relapsu VVK počas 12-mesačného obdobia štúdie.

E.5.1.1

Timepoint(s) of evaluation of this end point

during active treatment period and follow-up period

počas obdobia aktívnej liečby a follow-up obdobia

E.5.2

Secondary end point(s)

•Number of patients with local 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 total severity score < 3 (Day 10 + 4 days)
oPatient reported outcome of time to termination of clinical symptoms using the 11-point numeric rating scale (NRS) for burning, itching, soreness/irritation
oSymptom relief reported by patients within the first 6 to 12 hours and 24 hours after first application of investigational product or active control. Symptom relief is defined as improvement of ≥ 2 points of symptoms compared to pre-treatment in the NRS.
oTime to symptom relief of ≥ 50% reported by patients after first
application of IMP
oMycological outcome: Vaginal swab culture negative for growth of Candida albicans and/or Candida species at the TOC visit (day 10 + 4 days)
•Proportion of patients with clinical relapse of VVC during maintenance period
•Proportion of patients with clinical relapse after end of active treatment (end of maintenance period to end of study visit)
•Number of overall clinical relapses during the entire study period
•Number of relapses per patient during the entire study period
•Number of patients with > 1 relapse during study period
•Proportion of patients with clinical cure (absence of signs and symptoms of VVC) 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
•Time to first clinical relapse during a 12 months study period (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)
•Number of patients with self reported relapse of VVC (subjective symptoms of VVC ≥ grade 3 improved with antimycotic treatment within three days)
•Sexual function related to pain and improvement thereof
•Number and percentage of patients with local adverse drug reactions grouped by severity
•Number and percentage of patients with AEs grouped by (i) severity, and (ii) causal relationship to study medication,
•Number and percentage of patients with Serious Adverse Events (SAEs) (i) in total and (ii) grouped by causal relationship to study medication

• Počet pacientok s lokálnymi nežiaducimi udalosťami a závažnými nežiaducimi udalosťami (SAE) s kauzálnym vzťahom ku štúdiovej liečbe
• Hlavné ciele počas akútnej fázy RVVK:
o Klinické vyliečenie (definované ako neprítomnosť znakov a symptómov VVK) pri návšteve k overeniu účinnosti liečby, deň 10 (+4 dni)
o Klinická odpoveď, definovaná ako príznaky a symptómy s celkovým skóre závažnosti < 3 (Deň 10 + 4 dni)
o Pacientkou hlásený výsledok času do ukončenia klinických príznakov pomocou 11-bodovej číselnej hodnotiacej škály (NRS) na pálenie, svrbenie, bolestivosť / podráždenie
o Zmiernenie príznakov hlásené pacientkami počas prvých 6 až 12 hodín a 24 hodín po prvej aplikácii skúšaného lieku alebo aktívnej kontroly. Zmiernenie príznakov je definované ako zlepšenie o ≥ 2 body príznakov v porovnaní s pred-liečbou v NRS.
o Čas do zmiernenia príznakov o ≥ 50% hlásený pacientkami po prvej aplikácii skúšaného lieku
o Mykologický výsledok: Vaginálna sterová kultúra negatívna na rast druhov Candida albicans a / alebo iných druhov rodu Candida pri návšteve TOC (deň 10 + 4 dni)
• Podiel pacientok s klinickým relapsom VVK počas udržiavacieho obdobia
• Podiel pacientok s klinickým relapsom po ukončení aktívnej liečby (koniec udržiavacej periódy až do návštevy k ukončeniu skúšania)
• Počet celkových klinických relapsov počas celého obdobia skúšania
• Počet relapsov na pacientku počas celého obdobia skúšania
• Počet pacientok s > 1 relapsom počas obdobia skúšania
• Podiel klinicky vyliečených pacientok (neprítomnosť znakov a symptómov VVK) 6, 8, 10 a 12 mesiacov po randomizácii
• Zlepšenie skóre kvality života, súvisiacej so zdravím, na konci pozorovacieho obdobia pomocou dotazníka EQ-5D
• Mykologický výsledok: Vaginálna sterová kultúra negatívna na rast druhov Candida albicans a / alebo iných druhov rodu Candida pri návšteve k ukončeniu liečby (EOT)
• Čas do prvého klinického relapsu počas 12-mesačného obdobia skúšania (klinický relaps VVK je definovaný ako skóre závažnosti VVC stupňa ≥ 3 s pozitívnym vaginálnym sterom (natívnym alebo KOH) s nádejnými kvasinkami alebo hýfami)
• Počet pacientok so samohláseným relapsom VVK (subjektívne príznaky VVK ≥ stupeň 3 sa zlepšili s antimykotickou liečbou do troch dní)
• Sexuálna funkcia súvisiaca s bolesťou a s jej zlepšením
•Počet a percento pacientok s lokálnymi nežiaducimi reakciami na liek zoskupené podľa závažnosti
•Počet a percento pacientok s AEs zoskupených podľa (i) závažnosti a (ii) kauzálneho vzťahu k skúšanému lieku,
•Počet a percento pacientok so závažnými nežiaducimi udalosťami (SAE) (i) spolu a (ii) zoskupené podľa kauzálneho vzťahu k štúdiovej liečbe

E.5.2.1

Timepoint(s) of evaluation of this end point

during active treatment period and follow-up period

počas obdobia aktívnej liečby a follow-up obdobia

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

dvojito maskované

Double-Dummy

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

PNPS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

357

F.4.2.2

In the whole clinical trial

432

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

standard of care treatment

štandardná liečba

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-11-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-09-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-11-18

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