Clinical Trials Register

Summary
EudraCT Number:	2016-000371-24
Sponsor's Protocol Code Number:	DOBO-01-16
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2016-03-18
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

Spain - AEMPS

A.2

EudraCT number

2016-000371-24

A.3

Full title of the trial

Multicenter pilot study for comparison of the efficacy of vaginal capsules with boric acid and L. gasseri and L. rhamnosus versus other vaginal drugs, in patients with bacterial or candida Vulvovaginitis.

Estudio piloto multicéntrico para comparar la eficacia de cápsulas vaginales con ácido bórico y L. gasseri y L. rhamnosus versus otro fármaco de elección con la misma vía de administración en pacientes con vulvovaginitis de etiología bacteriana o candidiásica.

A.3.1

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

Multicenter study for comparison of the efficacy of vaginal capsules with boric acid and probiotics versus other vaginal drugs, in patients with bacterial or fungal vaginal infection.

Estudio multicéntrico para comparar la eficacia de cápsulas vaginales con ácido bórico y probióticos versus otro fármaco de elección con la misma vía de administración en pacientes con infección vaginal bacteriana o fúngica.

A.4.1

Sponsor's protocol code number

DOBO-01-16

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	Laboratorios Ordesa
B.1.3.4	Country	Spain
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	Laboratorios Ordesa
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Clever Instruments
B.5.2	Functional name of contact point	Jordi Amigó
B.5.3	Address:
B.5.3.1	Street Address	Carrer del Bruc
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08037
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034932080000
B.5.5	Fax number	0034934590997
B.5.6	E-mail	clever@recerca.com

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	Yes
D.2.1.1.1	Trade name	Iside 22 (Italy)
D.2.1.1.2	Name of the Marketing Authorisation holder	Pizeta Pharma S.p.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Boric acid + L. gasseri y L. rhamnosus
D.3.2	Product code	0546
D.3.4	Pharmaceutical form	Vaginal capsule
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	BORIC ACID
D.3.9.1	CAS number	10043-35-3
D.3.9.2	Current sponsor code	0546
D.3.9.3	Other descriptive name	BORACID
D.3.9.4	EV Substance Code	SUB12471MIG
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)	Yes
	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	Gine-Canesten
D.2.1.1.2	Name of the Marketing Authorisation holder	BAYER HISPANIA SL
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Gine-Canesten
D.3.4	Pharmaceutical form	Vaginal tablet
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	.
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	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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: 3
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	DALACIN
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER SL
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	DALACIN
D.3.4	Pharmaceutical form	Vaginal capsule
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	CLINDAMYCIN
D.3.9.1	CAS number	24696-19-3
D.3.9.2	Current sponsor code	.
D.3.9.3	Other descriptive name	CLINDAMYCIN PHOSPHATE
D.3.9.4	EV Substance Code	SUB01344MIG
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	100
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Bacterial or candidiasic vulvovaginitis

Vulvovaginitis bacteriana o candidiásica

E.1.1.1

Medical condition in easily understood language

Fungal or bacterial vaginal infections

Infecciones vaginales por hongos o bacterias

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

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 evaluate the efficacy of use of a vaginal form with boric acid and probiotics for the treatment of symptomatic episodes of vulvovaginitis (VV) against a control treatment drug (regarding a VV etiology)

Evaluar la eficacia de una fórmula de aplicación vaginal con ácido bórico y probióticos para el tratamiento de episodios sintomáticos de vulvovaginitis (VV) frente a un tratamiento farmacológico control (en función de la etiología de la VV).

E.2.2

Secondary objectives of the trial

To determine the incidence of recurrence / relapse within 3 months.

Determinar la incidencia de recurrencia/recaídas a los 3 meses.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Women:
>18 years.

With symptoms of vulvovaginal infection.

IC delivered.

Mujeres de edad ?18 años.

Mujeres con manifestaciones clínicas de VV infecciosa.

Mujeres que acepten participar mediante la firma del consentimiento
informado.

E.4

Principal exclusion criteria

- Clinical evidence of Chlamydia trachomatis, Trichomona vaginalis, Neisseria gonorrhoeae o Herpes simplex.
- Use of antifungal or probiotics during the last 2 weeks before the
study.
- Patients receiving other treatment with probiotics, vitamin complexes that could interfere significantly with the study evaluations.
- Pregnant patients.
- Patients capable of becoming pregnant.
- Patients menstruating at the time of inclusion.
- Breast-feeding.
- Immunocompromised patients.
- Patients who, based on the judgment of the investigator, is not foreseen will complete the follow.

- Cuadro clínico de Chlamydia trachomatis, Trichomona vaginalis, Neisseria gonorrhoeae o Herpes simplex.
- Uso de antimicóticos o probióticos durante las 2 últimas semanas previas al estudio.
- Pacientes que estén recibiendo algún otro tratamiento con probióticos, complejos vitamínicos que pueda interferir de forma significativa con las evaluaciones del estudio.
- Pacientes embarazadas.
- Pacientes susceptibles de quedarse embarazadas.
- Pacientes en periodo de menstruación al momento de la inclusión.
- Pacientes en periodo de lactancia.
- Pacientes inmunodeprimidas.
- Pacientes que, en base al criterio del investigador, se prevea no completarán el seguimiento.

E.5 End points

E.5.1

Primary end point(s)

- Number of patients with resolution of symptoms in each group at 2 weeks of the treatment.

- Número de pacientes con resolución de los síntomas en cada grupo a las 2 semanas de terminar el tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

1 months

1 meses

E.5.2

Secondary end point(s)

- Number of patients with recurrence of VV during the monitoring in each treatment group (incidence of relapse at 3 months).
- Changes in vaginal pH level in each group.
- Number of patients with "clue cells" or hyphae smear fresh.
- Profile and proportion of isolation of pathogens in culture.
- Increased population of Lactobacillus spp. post-treatment.
- Rescue success rate in the different scenarios.
- Relationship between compliance and treatment effectiveness.
- Relationship between compliance and recurrence at 3 months.
- Percentage of cases with good tolerability of the treatment.
- Rate of adverse events.
- Tolerability of treatment.
- Proportion of patients with mixed infections (VC + VB)

- Número de pacientes con recurrencia de VV durante el período de seguimiento en cada grupo de tratamiento (incidencia de recurrencias a los 3 meses).
- Cambios en el nivel pH vaginal en cada grupo.
- Número de pacientes con ?clue cells? o hifas en el frotis en fresco.
- Perfil y proporción de aislamiento de patógenos en cultivo.
- Aumento de la población de Lactobacillus spp. post-tratamiento.
- Tasa de éxito del rescate en los diferentes escenarios.
- Relación entre el cumplimiento y la efectividad del tratamiento.
- Relación entre el cumplimiento y las recurrencias a los 3 meses.
- Porcentaje de casos con buena tolerabilidad del tratamiento.
- Tasa de acontecimientos adversos.
- Tolerabilidad del tratamiento.
- Proporción de pacientes con infecciones mixtas (VC + VB)

E.5.2.1

Timepoint(s) of evaluation of this end point

3 months

3 meses

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

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)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Cross over: en caso de rescate

Cross over: In case of rescue

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Cross over: en caso de rescate

Cross over: In case of rescue

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

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

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

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

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:

F.1.3

Elderly (>=65 years)

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.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)

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

2016-05-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-05-23

P. End of Trial
P.	End of Trial Status	Ongoing

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