Clinical Trials Register

Summary
EudraCT Number:	2012-004100-35
Sponsor's Protocol Code Number:	FSJD-PIOSPIMET-2012
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-10-29
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

2012-004100-35

A.3

Full title of the trial

A prospective, open-label, randomized, two-armed clinical trial to evaluate the efficacy and safety of a combination of ethinyl-estradiol and levonorgestrel versus a low-dose combination of pioglitazone + spironolactone + metformin in adolescents with ovarian hyperandrogenism and hyperinsulinemia: Effects on ovulatory function, parameters of chronic inflammation, on cardiovascular risk factors and on risk factors for the development of type 2 diabetes

Ensayo clínico prospectivo, abierto, aleatorizado, con dos grupos de pacientes para evaluar la eficacia y la seguridad de la combinación de Etinil-estradiol y levonorgestrel versus la combinación de pioglitazona, espironolactona y metformina a dosis bajas en adolescentes con hiperandrogenismo ovárico e hiperinsulinismo: efectos sobre la función ovulatoria, parámetros de inflamación crónica, marcadores de riesgo cardiovascular y de desarrollo de diabetes tipo 2

A.3.1

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

clinical trial in adolescents with ovarian hyperandrogenism and hyperinsulinemia: Effects on ovulatory function, parameters of chronic inflammation, on cardiovascular risk factors and on risk factors for the development of type 2 diabetes

Ensayo clínico en adolescentes con hiperandrogenismo ovárico e hiperinsulinismo: efectos sobre la función ovulatoria, parámetros de inflamación crónica, marcadores de riesgo cardiovascular y de desarrollo de diabetes tipo 2.

A.4.1

Sponsor's protocol code number

FSJD-PIOSPIMET-2012

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	Fundació per la Recerca i la Docència Sant Joan de Déu
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Ministerio de Sanidad y Política Social
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	SERMES-CRO
B.5.2	Functional name of contact point	Dña. Lena M. Erbiti León
B.5.3	Address:
B.5.3.1	Street Address	C/ Rufino González 14 2º Dcha
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28037
B.5.3.4	Country	Spain
B.5.4	Telephone number	3491375 69 30
B.5.5	Fax number	3491754 27 21
B.5.6	E-mail	lena_erbiti@sermes.org

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	Metformina Sandoz
D.2.1.1.2	Name of the Marketing Authorisation holder	Sandoz Farmacéutica, S.A.
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	Metformina
D.3.4	Pharmaceutical form	Tablet
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	Metformina
D.3.9.3	Other descriptive name	Metformina
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	850
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	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	Aldactone Pfizer
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER, S.L.
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	espironolactona
D.3.4	Pharmaceutical form	Tablet
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	Espironolactona
D.3.9.3	Other descriptive name	Espironolactona
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	25
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	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	Aldactone Pfizer
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER, S.L.
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	espironolactona
D.3.4	Pharmaceutical form	Tablet
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	Espironolactona
D.3.9.3	Other descriptive name	Espironolactona
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: 4
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	Actos®
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorios Takeda
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	Clorhidrato de pioglitazona
D.3.4	Pharmaceutical form	Tablet
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	PIOGLITAZONE
D.3.9.3	Other descriptive name	clorhidrato de pioglitazona
D.3.9.4	EV Substance Code	SUB09857MIG
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	15
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: 5
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	LOETTE DIARIO
D.2.1.1.2	Name of the Marketing Authorisation holder	Wyeth Farma, S.A.
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	LOETTE DIARIO
D.3.4	Pharmaceutical form	Tablet
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	levonorgestrel
D.3.9.1	CAS number	797-63-7
D.3.9.3	Other descriptive name	LEVONORGESTREL
D.3.9.4	EV Substance Code	SUB08483MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	etinilestradiol
D.3.9.3	Other descriptive name	etinilestradiol.
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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

Ovarian hyperandrogenism

hiperandrogenismo ovárico

E.1.1.1

Medical condition in easily understood language

Polycystic Ovary Syndrome

Síndrome del ovario poliquístico

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

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

1)To study the efficacy and tolerability of low-dose combination treatment with pioglitazone, spironolactone and metformin (PioSpiMet) on endocrine-metabolic, vascular and inflammatory parameters, body composition (visceral and intrahepatic fat) and ovulatory function in adolescents with ovarian hyperandrogenism and hyperinsulinemia and without pregnancy risk;
2)To compare the effects of the treatment with PioSpiMet to the effects of the treatment with an oral contraceptive containing ethinyl-estradiol and levonorgestrel, on endocrine-metabolic, vascular and inflammatory parameters and body composition in two groups of adolescents of a similar age and baseline characteristics;
3)To compare the evolutionary changes of the endocrine-metabolic and vascular parameters and body composition in the 6 months after stopping treatment; to compare the effects of the two treatments on ovulatory function after stopping treatment. To assign the best treatment to the patients.

1)Estudiar la eficacia y tolerancia del tratamto combinado con pioglitazona, espironolactona y metformina (PioSpiMet) a dosis bajas sobre parámetros endocrinometabólicos, vasculares,inflamatorios composición corporal (grasa visceral e intrahepática)función ovulatoria en adolescentes con hiperandrogenismo ováricoehiperinsulinismo sin riesgo de embarazo 2)Comparar los efectos del tratamto con PioSpiMet sobre los parámet. endocrino-metabólicos, vasculares, inflamatorios y de composición corporal con los obtenidos en un grupo de adolescentes con edad y características basales similares tratadas con aticonceptivo oral conteniendo etinil-estradiol + levonorgestre 3)Comparar los cambios evolutivos de los parámet. endocrinometabólicos, vasculares,de composición corporal en los 6 meses posteriores a la suspensión del tratamnto;comparar los efectos de las dos terapéuticas sobre la función ovulatoria posterior a la finalización del tratamiento.Adjudicación del mejor tratamiento a las pacientes.

E.2.2

Secondary objectives of the trial

not applicable

no aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Age equal to or more than 14 years and less than 18 years
2) Menarche at least two years before
3) Body mass index (BMI) below 97th percentile and above the 10th percentile according to age (3)
4) Clinical hyperandrogenism:
a)Hirsutism and/or acne
b)Oligomenorrhea or amenorrhea
5) Biochemical hyperandrogenism:
a)Total testosterone > 60 ng/dL and/or free androgen index > 5 (1.2)
b)Androstenedione > 160 ng/dL
6) Hyperinsulinemia:
a)Basal insulin > 15 ?U/mL
b)Glucose/insulin ratio < 7 or insulin peak in the oral glucose load > 100 ?UmL (1.2)

1) Edad igual o superior a los 14 años e inferior a los 18 años
2) Menarquia como mínimo 2 años antes
3) Índice de masa corporal (IMC) inferior al percentil 97 y superior al percentil 10 para la edad (3)
4) Hiperandrogenismo clínico:
a)Hirsutismo y/o acné
b)Oligomenorrea o amenorrea
5) Hiperandrogenimmo bioquímico:
a)Testosterona total > 60ng/dL y/o índice de andrógenos libres > 5 (1,2)
b)Androstendiona > 160 ng/dL
6) Hiperinsulinismo:
a)Insulina basal > 15 mU/mL
b)Cociente glucosa/insulina < 7 ó pico de insulina en la sobrecarga oral de glucosa > 100 mUmL (1,2)

E.4

Principal exclusion criteria

1)Pregnancy or pregnancy risk: the patient must provide a written guarantee to abstain from intercourse during the study period or agree to use a barrier method of contraception.
2)Congenital adrenal hyperplasia due to 21-hydroxylase deficiency
3)Hyperprolactinemia
4)Cushing's syndrome
5)Uncontrolled hypothyroidism
6)Liver or renal dysfunction of the CPK or the LDH
7)Diabetes or glucose intolerance
8)Known skin allergies
9)Treatment during the previous six months with antiandrogens, estro-progestins, or drugs that interfere with the lipid and carbohydrate metabolism.
10)The existence of known bacterial infections.
11)Inflammatory bowel disease.
12) Patient's with precedents allergy symptons, contraindications or intolerance to the used drugs.

1)Embarazo o riesgo de embarazo: la paciente garantizara por escrito la ausencia de relaciones sexuales durante el período de estudio o la utilización de un método barrera en caso de que tenga intención de mantenerlas
2)Hiperplasia suprarrenal congénita por déficit de 21-hidroxilasa
3)Hiperprolactinemia
4)Síndrome de Cushing
5)Hipotiroidismo no controlado
6)Alteraciones de la función hepática, renal, de las CPK o de la LDH
7)Diabetes o intolerancia a la glucosa
8)Alergias cutáneas conocidas
9)Tratamiento con antiandrógenos, estro-progestágenos, o fármacos que interfieran con el metabolismo lipídico e hidrocarbonado en los 6 meses previos.
10)Existencia de infecciones bacterianas conocidas.
11)Enfermedad inflamatoria intestinal.
12)Pacientes con historia de alergia, contraindicación o intolerancia a los fármacos utilizados.

E.5 End points

E.5.1

Primary end point(s)

Basal insulin, insulin sensitivity (HOMA), visceral abdominal fat, intrahepatic lipid content, IMT (carotid intima-media thickness). A reduction in HOMA equal to or more than 10%, accompanied by a decrease in basal insulin amounts by at least 10%, and two or more of the following changes: a decrease of visceral fat > 20%, a decrease of the intrahepatic lipid content > 30%, or a decrease of the IMT > 20% will be considered as a positive and discriminative response.

nsulina basal, sensibilidad a la insulina (HOMA), grasa abdominal visceral, contenido de lípidos intrahepático, IMT. Se considerara una respuesta positiva y discriminativa una disminución del HOMA igual o superior al 10%, acompañada de una reducción de las cifras de insulina basal de la menos un 10%, y de dos o más de los cambios siguientes: disminución de la grasa visceral >20%, del contenido de lípidos intrahepático > 30%, o del IMT > 20%.

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months, 12 months and 6 months post treatment

6 meses, 12 meses y 6 meses post tratamiento

E.5.2

Secondary end point(s)

Not applicable

No aplica

E.5.2.1

Timepoint(s) of evaluation of this end point

Not applicable

No aplica

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

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

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

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

LVLS

LPLV

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.6.1

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:

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Under 18 years old.

Menores de edad.

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)

not applicable

no aplica

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

2012-12-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-11-07

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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