Clinical Trials Register

Summary
EudraCT Number:	2021-000989-15
Sponsor's Protocol Code Number:	DR200090
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2021-03-01
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2021-000989-15

A.3

Full title of the trial

Oxytocin versus Prostaglandins for labor Induction of women with an unfavorable Cervix after 24 hours of cervical ripening: a multicenter non inferiority randomized trial

Oxytocine versus Prostaglandines pour le déclenchement du travail des femmes dont le col est défavorable après 24 heures de maturation cervicale : essai multicentrique randomisé de non infériorité

A.3.1

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

Oxytocin versus Prostaglandins for labor Induction of women with an unfavorable Cervix after 24 hours of cervical ripening: a multicenter non inferiority randomized trial

A.3.2

Name or abbreviated title of the trial where available

OPIC

A.4.1

Sponsor's protocol code number

DR200090

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	University Hospital, Tours
B.1.3.4	Country	France
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	DGOS
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University Hospital, Tours
B.5.2	Functional name of contact point	Yoann DESVIGNES, CRA coordinator
B.5.3	Address:
B.5.3.1	Street Address	DRCI Centre Val de Loire - 2 bd Tonnellé
B.5.3.2	Town/ city	Tours
B.5.3.3	Post code	37044
B.5.3.4	Country	France
B.5.4	Telephone number	+330247474632
B.5.5	Fax number	+330247474662
B.5.6	E-mail	cpcq@chu-tours.fr

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	OXYTOCINE PANPHARMA
D.2.1.1.2	Name of the Marketing Authorisation holder	PANPHARMA
D.2.1.2	Country which granted the Marketing Authorisation	France
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.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	OXYTOCIN
D.3.9.1	CAS number	50-56-6
D.3.9.4	EV Substance Code	SUB09580MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/mg international unit(s)/milligram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	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	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	PROPESS
D.2.1.1.2	Name of the Marketing Authorisation holder	FERRING S.A.S
D.2.1.2	Country which granted the Marketing Authorisation	France
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.3.4	Pharmaceutical form	Vaginal delivery system
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	DINOPROSTONE
D.3.9.1	CAS number	363-24-6
D.3.9.4	EV Substance Code	SUB07195MIG
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	10
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	ANGUSTA
D.2.1.1.2	Name of the Marketing Authorisation holder	AZANTA DANMARK A/S
D.2.1.2	Country which granted the Marketing Authorisation	France
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.3.4	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	MISOPROSTOL
D.3.9.1	CAS number	59122-46-2
D.3.9.4	EV Substance Code	SUB08998MIG
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: 4
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	PROSTINE E2
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER HOLDING FRANCE
D.2.1.2	Country which granted the Marketing Authorisation	France
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.3.4	Pharmaceutical form	Vaginal gel
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	DINOPROSTONE
D.3.9.1	CAS number	363-24-6
D.3.9.4	EV Substance Code	SUB07195MIG
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.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

Labor Induction of women with an unfavorable Cervix after 24 hours of cervical ripening

Déclenchement du travail des femmes dont le col est défavorable après 24 heures de maturation cervicale

E.1.1.1

Medical condition in easily understood language

Labor Induction

Déclenchement du travail

E.1.1.2

Therapeutic area

Body processes [G] - Reproductive physiologi cal processes [G08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10023540
E.1.2	Term	Labor induced
E.1.2	System Organ Class	100000004868

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 show that, among women with an unfavorable cervix after a first cervical ripening, induction of labor with oxytocin is not associated with an increased risk of caesarean delivery in comparison with repeating cervical ripening with prostaglandins.

Montrer que, chez les femmes présentant un col de l'utérus défavorable après une première maturation cervicale, le déclenchement avec de l’oxytocine, par rapport à la répétition de la maturation cervicale avec les prostaglandines, n'est pas associé à un risque augmenté d'accouchement par césarienne.

E.2.2

Secondary objectives of the trial

Clinical objectives:
To show that, among women with an unfavorable cervix after a first cervical ripening, induction of labor with oxytocin in comparison with repeated cervical ripening is associated with a reduced time to delivery and increased satisfaction of women.
Also to show that maternal morbidity (instrumental delivery, infection, post-partum haemorrhage, sphincter injury, blood transfusion, admission in an intensive care unit) and neonatal morbidity (neonatal infection, neonatal acidosis, admission in an intensive care unit) are similar for these two strategies.

Health-economic objective:
To evaluate, in a joint analysis, that inducing labor with oxytocin is clinically not inferior in terms of caesarean delivery rate and not more expensive (economic non inferiority) in comparison with repeated cervical ripening.

Objectifs cliniques :
Montrer que, chez les femmes dont le col de l'utérus est défavorable après une première maturation cervicale, le déclenchement du travail avec de l'ocytocine par rapport à une maturation cervicale répétée est associé à une réduction du délai d'accouchement et à une satisfaction accrue des femmes.
Montrer également que la morbidité maternelle (accouchement instrumental, infection, hémorragie post-partum, lésion du sphincter, transfusion sanguine, admission dans une unité de soins intensifs) et la morbidité néonatale (infection néonatale, acidose néonatale, admission dans une unité de soins intensifs) sont similaires pour ces deux stratégies.

Objectif médico-économique :
Evaluer, dans une analyse conjointe, que l'induction du travail par l'ocytocine n'est pas cliniquement inférieure en termes de taux d'accouchement par césarienne et n'est pas plus coûteuse (non infériorité économique) par rapport à une maturation cervicale répétée.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Pregnant woman
• ≥ 18 years old
• With a singleton cephalic pregnancy
• Between ≥37+0 weeks and ≤ 42+0 weeks of gestation
• Gestational age estimated from the first trimester ultrasound (realized between 11+0 and 13+6 weeks of gestation)
• With a medical indication of labor with a previous pharmacological or mechanical cervical ripening of 24 hours
• Bishop score ≤ 6 at inclusion (unfavorable cervix)
• French health insurance policy holder
• Written informed consent

• Femme enceinte
• Age ≥ 18 ans
• Grossesse unique avec un fœtus en présentation céphalique
• A un terme ≥ 37+0 SA et ≤ 42+0 SA
• Age gestationnel estimé à partir d’une échographie réalisée entre 11+0 SA et 13+6 SA
• Ayant bénéficié d’une première maturation cervicale pharmacologique ou mécanique de 24 heures
• Score de Bishop ≤ 6 à l'inclusion (col défavorable)
• Affiliation à la sécurité sociale
• Consentement éclairé écrit

E.4

Principal exclusion criteria

• Any measures of legal protection
• Prior caesarean section or uterine scar
• Contra-indications to a vaginal delivery
• Foetus with suspected severe congenital abnormalities
• Pathological foetal heart rate
• Contra-indications to ANGUSTA® (oral misoprostol, cervical ripening agent)
• Contra-indications to PROPESS® (vaginal slow releasing system of dinoprostone, cervical ripening agent)
• Contra-indications to PROSTINE® (vaginal gel of dinoprostone, cervical ripening agent)
• Contra-indications for using oxytocin
• Woman in labor or with more than 3 contractions / 10 minutes

• Mesure de protection juridique
• Antécédent de césarienne ou de cicatrice utérine
• Contre-indications à un accouchement par les voies naturelles
• Fœtus avec suspicion d'anomalie congénitale sévère
• Anomalie du rythme cardiaque fœtale
• Contre-indications aux prostaglandines (ANGUSTA®, PROPESS®, PROSTINE®)
• Contre-indications à l’oxytocine
• Femme en travail ou avec plus de 3 contractions / 10 minutes

E.5 End points

E.5.1

Primary end point(s)

The main outcome is the rate of caesarean delivery, whatever the indication of the caesarean delivery

Le critère de jugement principal était le taux d’accouchement par césarienne quelque soit l’indication de la césarienne

E.5.1.1

Timepoint(s) of evaluation of this end point

At delivery

A l'accouchement

E.5.2

Secondary end point(s)

Clinical outcomes:
• Time from intervention to delivery in hours
• Delivery within 12 hours
• Maternal satisfaction
• Need for induction with oxytocin (for women in the control group)
• Indication of caesarean in case of caesarean delivery
• Instrumental delivery
• Indication for the use of instruments in case of instrumental delivery
• Suspicion of per-partum infection
• Post-partum haemorrhage
• Severe post-partum haemorrhage
• Anal sphincter injury
• Blood transfusion
• Need for antibiotics
• Admission to intensive care unit
• Neonatal morbidity
o An APGAR score at 5 minutes under 7
o Neonatal acidosis defined as umbilical arterial pH <7,00
o Early neonatal infection
o Admission in an intensive care unit

Health-economic outcome:
Proportion of incremental cost-effect pairs that lies into the non-inferiority area, for various values of economic non–inferiority margin, and for a constant clinical non-inferiority margin (7%).

Critères cliniques :
Comparer pour les deux stratégies :
• délai intervention-accouchement
• taux d’accouchement à 12 heures
• la satisfaction des femmes
• la nécessité d’un déclenchement à l’oxytocine (pour les femmes du groupe contrôle uniquement)
• indication de césarienne en cas de naissance par césarienne
• aide à l’extraction
• indication de l’aide à l’extraction
• suspicion d’infection du per partum
• hémorragie du post partum
• hémorragie sévère du post partum
• lésion du sphincter
• transfusion sanguine à l’accouchement
• besoin d’une antibiothérapie per partum
• admission en unité de soins intensifs
• critères de morbidité néonatale
o score d’Apgar <7 à 5 minutes
o infection néonatale précoce
o acidose néonatale
o admission en unité de soins intensifs

Critère médico-économique :
Proportion de points différentiels coûts-résultats qui se situent dans la zone de non-infériorité, pour différentes valeurs de la marge de non-infériorité économique et sachant une marge de non-infériorité clinique constante (7 %).

E.5.2.1

Timepoint(s) of evaluation of this end point

From inclusion to discharge of the mother and child.
Women's satisfaction will be assessed at 4 weeks postpartum.

De l'inclusion à la sortie de la mère et de l'enfant.
La satisfaction des femmes sera évaluée à 4 semaines post-partum

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

Yes

E.6.13.1

Other scope of the trial description

Medico-economic

Médico-économique

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

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

The end of participation in the study corresponds to the patient and the baby are discharged and the questionnaire evaluating maternal satisfaction is received (completed at 4 weeks postpartum).

La fin de la participation à l'étude correspond au retour à domicile de la patiente et du bébé et à la réception du questionnaire d'évaluation de la satisfaction maternelle (complété à 4 semaines post-partum).

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:

1494

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

F.3.3.3

Pregnant women

Yes

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

1494

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)

None

Aucun

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

2021-07-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-10

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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