Clinical Trials Register

Summary
EudraCT Number:	2013-003945-40
Sponsor's Protocol Code Number:	BAY1002670/15788
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:	2014-04-01
Trial results	View 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

2013-003945-40

A.3

Full title of the trial

A randomized, parallel-group, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of different doses of BAY 1002670 in subjects with uterine fibroids over 3 months

Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo de grupos paralelos para valorar la eficacia y la seguridad de diferentes dosis de BAY 1002670 durante 3 meses en mujeres con miomas uterinos.

A.3.1

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

Assess safety and efficacy of BAY 1002670 in subjects with uterine fibroids

Evaluar la eficacia y la seguridad de BAY 1002670 en pacientes con miomas uterinos

A.3.2

Name or abbreviated title of the trial where available

ASTEROID 1

A.4.1

Sponsor's protocol code number

BAY1002670/15788

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	Bayer HealthCare AG
B.1.3.4	Country	Germany
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	Bayer HealthCare AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bayer HealthCare AG
B.5.2	Functional name of contact point	Bayer Clinical Trials Contact
B.5.3	Address:
B.5.3.1	Street Address	CTP Team/Ref:"EU CTR"/ Bayer Pharma AG
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13342
B.5.3.4	Country	Germany
B.5.4	Telephone number	0034900102372
B.5.6	E-mail	clinical-trials-contact@bayerhealthcare.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	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	BAY 1002670 coated tablet 0.5 mg 242
D.3.2	Product code	BAY1002670
D.3.4	Pharmaceutical form	Film-coated 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	vilaprisan
D.3.9.2	Current sponsor code	BAY 1002670
D.3.9.3	Other descriptive name	BAY 1002670 micronized
D.3.9.4	EV Substance Code	SUB31208
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	0.5
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	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	BAY 1002670 coated tablet 1 mg 244
D.3.2	Product code	BAY1002670
D.3.4	Pharmaceutical form	Film-coated 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	vilaprisan
D.3.9.2	Current sponsor code	BAY 1002670
D.3.9.3	Other descriptive name	BAY 1002670 micronized
D.3.9.4	EV Substance Code	SUB31208
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	1
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	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	BAY 1002670 coated tablet 2 mg 245
D.3.2	Product code	BAY1002670
D.3.4	Pharmaceutical form	Film-coated 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	vilaprisan
D.3.9.2	Current sponsor code	BAY 1002670
D.3.9.3	Other descriptive name	BAY 1002670 micronized
D.3.9.4	EV Substance Code	SUB31208
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	2
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	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	BAY 1002670 coated tablet 4 mg 246
D.3.2	Product code	BAY1002670
D.3.4	Pharmaceutical form	Film-coated 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	vilaprisan
D.3.9.2	Current sponsor code	BAY 1002670
D.3.9.3	Other descriptive name	BAY 1002670 micronized
D.3.9.4	EV Substance Code	SUB31208
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	4
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	Film-coated tablet
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

Women, 18 to 50 years old, with uterine fibroids documented by transvaginal or abdominal ultrasound at screening with at least 1 uterine fibroid with largest diameter >=3.0 cm and heavy menstrual bleeding >80 mL will be eligible for enrollment in the study.

Se considerarán elegibles para su inclusión en el estudio las mujeres de edades comprendidas entre 18 y 50 años, con miomas uterinos confirmados mediante ecografía abdominal o transvaginal realizada en la selección que presenten como mínimo 1 mioma uterino de >= 3,0 cm en su diámetro mayor y sangrado menstrual abundante (SMA) > 80 ml.

E.1.1.1

Medical condition in easily understood language

Uterine Fibroids

Miomas uterinos

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	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10046784
E.1.2	Term	Uterine fibroids
E.1.2	System Organ Class	100000004864

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10016628
E.1.2	Term	Fibroids
E.1.2	System Organ Class	100000004864

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10022794
E.1.2	Term	Intramural leiomyoma of uterus
E.1.2	System Organ Class	100000004864

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 assess the dose-response relationship of BAY 1002670 in subjects with uterine fibroids.

Evaluar la relación dosis-respuesta de BAY 1002670 en pacientes con miomas uterinos.

E.2.2

Secondary objectives of the trial

To evaluate the safety of different doses of BAY 1002670 in subjects with uterine fibroids.
To establish a population pharmacokinetic/pharmacodynamic relationship for BAY 1002670 in subjects with uterine fibroids.
To assess the interchangeability of menstrual pictogram and alkaline hematin method for judgment of menstrual blood loss.

Evaluar la seguridad de diferentes dosis de BAY 1002670 en pacientes con miomas uterinos.
Establecer la relación farmacocinética/farmacodinamia poblacional de BAY 1002670 en pacientes con miomas uterinos.
Evaluar la intercambiabilidad del pictograma menstrual y el método de la hematina alcalina para valorar las hemorragias menstruales.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed and dated informed consent
2. Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter >=3.0 cm
3. 18 to 50 years of age at the time of screening
4. Heavy menstrual bleeding >80 mL documented by MP during the bleeding episode following the screening visit
5. Normal or clinically insignificant cervical smear not requiring further follow-up
6. An endometrial biopsy performed at the screening visit 2 (Visit 2), without significant histological disorder such as endometrial hyperplasia or other significant endometrial pathology
7. Use of a double barrier method (eg. condom or diaphragm, plus spermicide) of contraception starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study
8. Good general health (except for findings related to uterine fibroids)

1.Consentimiento informado firmado y fechado
2.Diagnóstico de mioma(s) uterino(s) documentado mediante ecografía abdominal o transvaginal realizada en la selección, con al menos 1 mioma con un diámetro máximo >=3,0 cm.
3.Mujeres de edad comprendida entre 18 y 50 años en el momento de la selección
4.Sangrado menstrual abundante (SMA) > 80 ml documentado mediante PM durante el episodio hemorrágico posterior a la visita de selección.
5.Citología vaginal normal o clínicamente no significativa, que no requiere seguimiento posterior
6.Una biopsia endometrial realizada en la visita de selección 2 (Visita 2), sin alteraciones histológicas significativas como hiperplasia endometrial u otra patología endometrial importante
7. Uso de un método anticonceptivo de doble barrera (p. ej., preservativo o diafragma más espermicida), a partir del episodio hemorrágico posterior a la visita de selección 1 (Visita 1) y hasta el final del estudio
8. Buen estado de salud general (exceptuando los signos relacionados con los miomas uterinos)

E.4

Principal exclusion criteria

1. Pregnancy or lactation
2. Uterine fibroid with largest diameter >10.0 cm
3. Hypersensitivity to any ingredient of the study drug
4. Laboratory values outside inclusion range before randomization and considered as clinically relevant
5. Hemoglobin values <6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values <10.9 g/dL will receive iron supplementation)
6. Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
7. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
8. Abuse of alcohol, drugs, or medicines
9. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results

1.Embarazo o lactancia (si han transcurrido menos de 3 meses desde el parto, aborto, o lactancia antes del inicio del tratamiento)
2.Mioma uterino con un diámetro máximo > 10,0 cm
3.Hipersensibilidad a cualquier componente del fármaco del estudio
4.Resultados analíticos que estén fuera del intervalo de inclusión antes de la aleatorización y que se consideren clínicamente relevantes
5.Concentración de hemoglobina <6 g/dl o cualquier trastorno que requiera una transfusión de sangre inmediata (las pacientes con niveles de hemoglobina <10,9 g/dl recibirán suplementos de hierro)
6.Cualquier enfermedad o proceso que pueda alterar la función de los órganos, sistemas y aparatos corporales y pudiera ocasionar una acumulación excesiva o una alteración de la absorción, del metabolismo o de la excreción del fármaco del estudio
7.Cualquier enfermedad o proceso que pudiera interferir en la realización del estudio o la interpretación de los resultados
8.Abuso de alcohol, drogas o medicamentos (p. ej., laxantes)
9.Uso de otros tratamientos que pudieran interferir en la realización del estudio o la interpretación de los resultados

E.5 End points

E.5.1

Primary end point(s)

Amenorrhea (yes/no)

Amenorrea (sí/no)

E.5.1.1

Timepoint(s) of evaluation of this end point

After end of the initial bleeding until treatment day 84

Después del final del sangrado inicial hasta el día 84 de tratamiento

E.5.2

Secondary end point(s)

1. Volume of menstrual blood loss per 28 days (assessed by Alkaline Hematin method)
2. Time to onset of controlled bleeding
3. Percent change in volume of largest fibroid compared to baseline

1. El volumen de hemorragia menstrual cada 28 días (evaluado mediante método de HA).
2. El tiempo hasta la aparición de hemorragias controladas.
3. El porcentaje de cambio en el volumen del mioma de mayor tamaño con respecto al periodo basal.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. During 12 weeks of treatment
2. Between baseline and 12 weeks of treatment
3. Between baseline and 12 weeks of treatment

1. Durante las 12 semanas de tratamiento
2. Entre la determinación basal y la de 12 semanas de tratamiento
3. Entre la determinación basal y la de 12 semanas de tratamiento

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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)

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Belgium

Bulgaria

Canada

Czech Republic

Finland

Germany

Hungary

Japan

Norway

Spain

Sweden

United States

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

LPLV (LVLS)

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 years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

300

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.4.2

For a multinational trial

F.4.2.1

In the EEA

175

F.4.2.2

In the whole clinical trial

300

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)

All pregnancies occurring during the treatment and follow-up periods will be followed for the outcome for both the mother and fetus/child (in case of a life birth) until first birthday of the child.

Para todos los embarazos que se produzcan durante los periodos de tratamiento y de seguimiento se realizará un seguimiento del desenlace, tanto de la madre como del feto/niño (en caso de nacido vivo) hasta el primer año de vida del niño.

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

2014-05-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-04-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-05-04

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