Clinical Trials Register

Summary
EudraCT Number:	2007-004076-38
Sponsor's Protocol Code Number:	511.118
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:	2007-12-27
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

2007-004076-38

A.3

Full title of the trial

Estudio abierto de 28 semanas de duración para evaluar la seguridad de flibanserina en dosis de 50 mg/día y 100 mg/día en mujeres premenopáusicas europeas con trastorno de deseo sexual hipoactivo

A Twenty Eight –Week, Open-Label, Safety Study of Flibanserin 50 milligrams to 100 milligrams daily in Premenopausal European Women With Hypoactive Sexual Desire Disorder

A.3.2

Name or abbreviated title of the trial where available

Magnolia

A.4.1

Sponsor's protocol code number

511.118

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Boehringer Ingelheim España S.A.
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	flibanserin
D.3.2	Product code	BIMT 17 BS
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	FLIBANSERIN
D.3.9.1	CAS number	167933075
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	flibanserin
D.3.2	Product code	BIMT 17 BS
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	FLIBANSERIN
D.3.9.1	CAS number	167933075
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	50
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	flibanserin
D.3.2	Product code	BIMT 17 BS
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	FLIBANSERIN
D.3.9.1	CAS number	167933075
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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

Trastorno de deseo sexual hipoactivo adquirido generalizado primario en mujeres premenopáusicas

Primary generalized acquired Hypoactive Sexual Desire Disorder in Premenopausal women

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10020933
E.1.2	Term	Hypoactive sexual desire disorder

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluar el perfil de seguridad de flibanserina durante 28 semanas adicionales de tratamiento en las mujeres tratadas con flibanserina en el ensayo original 511.77 e investigar la distribución de los regímenes posológicos preferidos por las pacientes durante el mantenimiento.

E.2.2

Secondary objectives of the trial

Evaluar la tolerabilidad y eficacia de flibanserina en dicha población de pacientes.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Mujeres con un diagnóstico primario de TDSH (de acuerdo con los criterios DSM-IV-TR especificados en el ensayo original 511.77), que sigan requiriendo tratamiento según la opinión del investigador y de acuerdo a su historial clínico actualizado y que se muestren dispuestas a continuar en este estudio de extensión. Esta continuación requiere un cumplimiento adecuado, a criterio del investigador, de la medicación y las visitas del estudio requeridas en el ensayo clínico original (visitas 1 a 9).

2. Las pacientes deberán haber utilizado un método anticonceptivo médicamente aceptable [es decir, método de doble barrera (p. ej., diafragma o preservativo y espermicida), tratamiento hormonal (anticonceptivo subcutáneo, inyectable, intravaginal u oral), dispositivo intrauterino, esterilización tubárica o esterilización quirúrgica de la pareja] durante al menos 3 meses antes de la visita basal y seguir utilizando dicho método durante el ensayo. Sin embargo, si se considera que el uso de un anticonceptivo es un factor que contribuye al TDSH de la paciente, será excluida del ensayo.

3. La paciente deberá acudir puntualmente a las visitas programadas, sus declaraciones médicas deberán coincidir con la información objetiva obtenida durante la visita basal, sus afirmaciones acerca de la historia clínica deberán ser coherentes y deberá comprometerse a cooperar con todas las evaluaciones del ensayo, así como ser capaz de realizarlas.

4. Las pacientes deberán ser capaces y mostrarse dispuestas a otorgar un consentimiento informado por escrito antes de participar en el ensayo, con arreglo a los requisitos administrativos. Las pacientes deberán tener una comprensión suficiente para comunicarse de manera eficaz con el investigador y mostrarse dispuestas a comentar su función sexual con el personal investigador.

5. Las pacientes deberán contar con una citología clínicamente aceptable según la lectura de un centro de citología (sin signos de neoplasia maligna o lesiones intraepiteliales epidermoides) dentro de los 6 meses previos a la visita basal.

E.4

Principal exclusion criteria

1. Pacientes con antecedentes de un TDM durante los 6 meses anteriores a la visita basal o una puntuación ≥ 14 en el Inventario de depresión de Beck© II, antecedentes de tentativa de suicidio según la Escala Beck de ideación suicida© o pacientes con una puntuación distinta de cero en los primeros cinco apartados de la Escala Beck de ideación suicida©. Consúltense los apéndices 10.1 y 10.2, respectivamente.

2. Pacientes con antecedentes de participación en un ensayo de otro fármaco en investigación (salvo el ensayo original de flibanserina) durante el mes anterior a la visita basal.

3. Pacientes que en la visita basal presentan indicios de enfermedad inflamatoria pélvica, infección urinaria o vaginal/vaginitis, cervicitis, cistitis intersticial, vulvodinia o atrofia vaginal importante.

4. Pacientes que están embarazadas (según una prueba de embarazo en suero en la visita basal) o lo han estado durante el mes anterior a la visita basal.

5. Pacientes que experimentan un estrés vital importante (como presión por cuidar de los hijos, cuidado de ancianos, pérdida de ingresos, muerte de un familiar, etc.) o discordia en la relación que podría interferir en la actividad sexual, salvo el malestar asociado al TDSH.

6. Alteraciones clínicamente significativas del ECG en la visita basal, según la opinión del investigador o el cardiólogo que haya realizado el ECG. Los siguientes valores en los parámetros del ECG se considerarán motivo de exclusión: intervalos QTc > 480 milisegundos (ms), intervalos PR > 240 ms e intervalos QRS > 110 ms.

7. En la visita basal, aspartato aminotransferasa o fosfatasa alcalina en suero ≥ dos veces el límite superior de la normalidad, nitrógeno ureico en sangre ≥ 30 mg/decilitro (dl) o creatinina plasmática ≥ 2 mg/dl. Pacientes con antecedentes de trastornos de la coagulación, tendencia anormal a la hemorragia, drepanocitosis, anemia (hemoglobina < 9,5 gramos/dl), leucopenia [< 2,5 x 103/microlitro (µl)], neutropenia (< 1,5 x 103/µl), linfopenia (< 0,8 x 103/µl), trombocitopenia (< 100 x 103/µl) o trombocitosis (> 500 x 103/µl) o glucemia en ayunas ≥ 140 mg/dl y 2+ de glucosuria.

8. Pacientes tratadas con medicación a las que se excluyó del ensayo de eficacia y seguridad original de flibanserina (dentro del mismo margen de tiempo antes de la visita basal), es decir, causante de disfunción sexual o de interacciones relacionadas con la seguridad (p. ej., antidepresivos, ansiolíticos, antipsicóticos, estabilizadores del estado de ánimo, anticonvulsivos o anticoagulantes). Consúltese el apéndice 10.3.

9. En la visita basal, pacientes con antecedentes de cáncer durante los 10 últimos años, a excepción de cáncer de piel no invasivo resecado con anterioridad.

E.5 End points

E.5.1

Primary end point(s)

El criterio principal de valoración es la proporción de pacientes que presentan Acontecimientos Adversos (AA) esperados y habituales a flibanserina de manera individual y colectiva, la proporción de retiradas por AA y la proporción de AA graves (AAG) relacionados con la medicación del estudio.

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

E.6.7

Pharmacodynamic

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

Information not present in EudraCT

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

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

E.8.1.1

Randomised

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

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

Information not present in EudraCT

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

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

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Information not present in EudraCT
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	No
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	20
F.4.2	For a multinational trial
F.4.2.1	In the EEA	450
F.4.2.2	In the whole clinical trial	450

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

2008-03-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-02-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-10-23

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