Clinical Trials Register

Summary
EudraCT Number:	2016-002855-48
Sponsor's Protocol Code Number:	BAY1002670/15789
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2017-05-08
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

2016-002855-48

A.3

Full title of the trial

A randomized, parallel-group, double-blind, double-dummy, active-controlled, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids

Estudio aleatorizado, multicéntrico, de grupos paralelos, doble ciego, doble enmascaramiento y con control activo para evaluar la eficacia y seguridad de vilaprisán en sujetos 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 Vilaprisan in Subjects with Uterine Fibroids

Evaluar la eficacia y seguridad de vilaprisán en sujetos con miomas uterinos

A.3.2

Name or abbreviated title of the trial where available

ASTEROID 5

A.4.1

Sponsor's protocol code number

BAY1002670/15789

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 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 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 AG
B.5.2	Functional name of contact point	Bayer Clinical Trials Contact
B.5.3	Address:
B.5.3.1	Street Address	"EU CTR"
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	0034900 102372
B.5.6	E-mail	clinical-trials-contact@bayer.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 2 mg 245
D.3.2	Product code	BAY 1002670
D.3.4	Pharmaceutical form	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.3.9.1	CAS number	1262108-14-4
D.3.9.2	Current sponsor code	BAY 1002670
D.3.9.3	Other descriptive name	BAY 1002670
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: 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	Esmya 5 mg tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Gedeon Richter Plc.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Esmya 5 mg tablets
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	ulipristal acetate
D.3.9.1	CAS number	126784-99-4
D.3.9.3	Other descriptive name	ULIPRISTAL ACETATE
D.3.9.4	EV Substance Code	SUB30470
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	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.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	Coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	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

Leiomyoma

Miomas uterinos

E.1.1.1

Medical condition in easily understood language

Uterine fibroids, heavy menstrual bleeding

Miomas uterinos, sangrado menstrual abundante

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	19.1
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	20.0
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	20.0
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

The primary objective of this study is to assess the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.

El objetivo principal de este estudio consiste en evaluar la eficacia de vilaprisán en sujetos con miomas uterinos en comparación con ulipristal.

E.2.2

Secondary objectives of the trial

The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids

El objetivo secundario de este estudio consiste en evaluar la eficacia y la seguridad de distintas pautas terapéuticas de vilaprisán en sujetos con miomas uterinos

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Women, 18 years or older at the time of Visit 1
2. Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm
3. Heavy menstrual bleeding (HMB) >80.0 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period
4.Use of an acceptable non-hormonal method of contraception
5. An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology.

1. Mujeres con una edad de 18 años o más en la Visita 1.
2. Diagnóstico de mioma(s) uterino(s) documentado mediante ecografía realizada en la selección, con al menos 1 mioma de ≥30 mm y menor a 120 mm en su diámetro máximo.
3. Sangrado menstrual abundante (SMA) > 80,0 ml documentado mediante pictograma menstrual (PM) en un episodio de sangrado durante el periodo de selección.
4. Uso de un método anticonceptivo no hormonal aceptable
5. Biopsia endometrial realizada durante el periodo de selección, sin alteraciones histológicas significativas como hiperplasia endometrial (incluida hiperplasia simple) u otra patología endometrial importante

E.4

Principal exclusion criteria

1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
2. Hypersensitivity to any ingredient of the study drugs
3. Hemoglobin values £6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values £10.9 g/dL will be recommended to use iron supplementation).
4. Any diseases, conditions, or medications 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 including
5. Abuse of alcohol, drugs, or medicines (eg, laxatives)
6. Undiagnosed abnormal genital bleeding
7. Any diseases or conditions 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. Hipersensibilidad a cualquier componente de los fármacos del estudio
3. Concentración de hemoglobina ≤6 g/dl o cualquier trastorno que requiera una transfusión de sangre inmediata (se recomendará a los sujetos con niveles de hemoglobina ≤ 10,9 g/dl el uso de suplementos de hierro).
4. Cualquier enfermedad, condición o medicamento 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
5. Abuso de alcohol, drogas o medicamentos (p. ej., laxantes)
6. Sangrado genital anómalo no diagnosticado
7. Cualquier enfermedad o condición que pudiera 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), Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days of the treatment period.

Amenorrea (sí/no), definida como sangrado menstrual <2 ml basado en el pictograma menstrual (PM) durante los últimos 28 días del periodo de tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

At 3 months and 9 months

A los 3 y a los 9 meses.

E.5.2

Secondary end point(s)

1) Amenorrhea (yes/no); Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days of the treatment period.
2) Absence of bleeding (yes/no); defined as no bleeding (spotting allowed) during the last 28 days of the treatment; based on the UF-DBD
3) Number of bleeding days;
4) Time to onset of controlled bleeding; Onset of controlled bleeding is defined by the first day, for which the menstrual blood loss (assessed by Menstrual pictogram) is less than 80.0 mL.
5) Heavy Menstrual Bleeding responder rate; Percentage of subjects with blood loss < 80.0 mL and 50% reduction compared to baseline (assessed by Menstrual Pictogram)
6) Percent change in volume of largest fibroid compared to baseline measured by MRI
7) Endometrial histology' Assess benign endometrium, presence or absence of hyperplasia or malignancy
8) Endometrial thickness by ultrasound

1) Amenorrea (sí/no), definida como sangrado menstrual <2 ml basado en el pictograma menstrual (PM) durante los últimos 28 días del periodo de tratamiento.
2) Ausencia de sangrado (sí/no); definido como falta de sangrado (manchado permitido) durante los últimos 28 días de tratamiento, basado en la UF-DBD
3) Número de días de sangrado
4) Tiempo hasta la aparición del sangrado controlado; la aparición de sangrado controlado se define como el primer día de un periodo de sangrado menstrual menor a 80.0 mL (evaluado por pictograma menstrual)
5) Tasa de respuesta de sangrado menstrual abundante; porcentaje de sujetos con sangrado < 80.0 mL y reducción del 50% comparado con el basal (evaluado por pictograma menstrual)
6) Porcentaje de cambio en el volumen del mioma de mayor tamaño comparado con el basal, medido por resonancia magnética.
7) Histología del endometrio; se evalúa como endometrio benigno, presencia o ausencia de hiperplasia o malignidad.
8) Grosor del endometrio medido por ecografía

E.5.2.1

Timepoint(s) of evaluation of this end point

1) Amenorrhea At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months
2) Absence of bleeding up to 24 months
3) Number of bleeding days from day 1 of the first treatment period until the day before the next treatment period after the last treatment period would start again normalized to 28 days
4) Time to onset of controlled bleeding at quarterly up to 24 months
5) Heavy Menstrual Bleeding responder rate; by treatment period up to 24 months
6) Percent change in volume of largest fibroid compared to baseline at baseline, at 12 months and at 24 months
7) Endometrial histology at baseline, at 12 months and at 24 months
8) Endometrial thickness once per 3-months-treatment period

1) Amenorrea a los 6, 12, 15, 18, 21 y 24 meses.
2) Ausencia de sangrado hasta los 24 meses
3) Número de días de sangrado desde el día 1 del primer periodo de tratamiento hasta el día previo al periodo de tratamiento siguiente, luego del último periodo de tratamiento se volvería a normalizarse a 28 días
4) Tiempo hasta la aparición del sangrado controlado, trimestralmente hasta 24 meses
5) Tasa de respuesta de sangrado menstrual abundante; por período de tratamiento hasta 24 meses.
6) Porcentaje de cambio en el volumen del mioma de mayor tamaño comparado con el basal, a los 12 y 24 meses.
7) Histología del endometrio, basal y a los 12 y 24 meses,
8) Grosor del endometrio, una vez por periodo de tratamiento de 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

Yes

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

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

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)

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

210

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

Australia

Austria

Belgium

Bulgaria

Canada

Czech Republic

Denmark

Finland

France

Germany

Hungary

Ireland

Italy

Korea, Republic of

Lithuania

Netherlands

Norway

Poland

Portugal

Slovakia

Spain

Sweden

Taiwan

Ukraine

United Kingdom

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

Última visita del último paciente.

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:

996

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

996

F.4.2.2

In the whole clinical trial

996

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 a case of life birth) until first birthday of the child.

Todos los embarazos que ocurran durante el periodo de tratamiento y de seguimiento se seguirán para ver el resultado tanto para la madre como para el feto/bebé (en caso que el nacimiento ocurra) hasta el primer año de vida del bebé.

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

2017-07-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-05-31

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
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