Clinical Trials Register

Summary
EudraCT Number:	2020-001077-79
Sponsor's Protocol Code Number:	HCB/2020/0212
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:	2020-06-12
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

2020-001077-79

A.3

Full title of the trial

VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)

A.3.1

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

Local prasterone for the treatment of vaginal atrophy

A.3.2

Name or abbreviated title of the trial where available

VIBRA

A.4.1

Sponsor's protocol code number

HCB/2020/0212

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 Clínic Recerca Biomèdica
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	Fundació Clínic Recerca Biomèdica
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	Fundació CLínic Recerca Biomèdica
B.5.2	Functional name of contact point	Secretaria de Ginecologia Clínic
B.5.3	Address:
B.5.3.1	Street Address	Villarroel 170
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08036
B.5.3.4	Country	Spain
B.5.4	Telephone number	34392275436
B.5.6	E-mail	secgine@clinic.cat

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	Intrarosa
D.2.1.1.2	Name of the Marketing Authorisation holder	Lacer
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	intrarosa
D.3.2	Product code	EMEA/H/C/004138
D.3.4	Pharmaceutical form	Pessary
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Vaginal use
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

Vaginal atrophy

E.1.1.1

Medical condition in easily understood language

Vaginal dryness and dyspareunia

E.1.1.2

Therapeutic area

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

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

Verify a clinical improvement of AVV without increasing levels of ultrasensitive blood estradiol in breast cancer survivors treated with
aromatase inhibitors by administering vaginal prasterone.

Constatar una mejoría clínica de la AVV sin incremento en los niveles de estradiol ultrasensible en sangre de pacientes con cáncer de mama tratadas con inhibidores de la aromatasa mediante la administración de prasterona vaginal.

E.2.2

Secondary objectives of the trial

a. Report improvement of symptoms, sexual function and quality of life
b. Verify a decrease in vaginal pH
c. Confirm an improvement in the maturational index of the vaginal epithelium
d. Demonstrate the non-modification of serum estrogen levels by determination of ultrasensitive estradiol

a. Reportar una mejoría de los síntomas, de la función sexual y de la calidad de vida
b. Constatar una disminución del pH vaginal
c. Constatar una mejoría del índice madurativo del epitelio vaginal
d. Demostrar la no modificación de los niveles séricos de estrógenos mediante determinación de estradiol ultrasensible

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1 CM treated with anti-hormonal therapy based on inhibitors of aromatase (IA) (letrozole, anastrozole or exemestane) ± analogues of the
GnRH (aGnRH)
2 Menopause (natural or induced) and signs / symptoms of vulvovaginal atrophy
3 Cytology and / or determination of Human Papillomavirus (HPV) negative
4 Intention or willingness to have sex

1 CM tratado con terapia anti-hormonal a base de inhibidores de la aromatasa (IA) (letrozol, anastrozol o exemestano) ± análogos de la
GnRH (aGnRH)
2 Menopausia (natural o inducida) y signos/síntomas de atrofia vulvovaginal
3 Citología y/o determinación del Virus del Papiloma Humano (VPH) negativas
4 Intención o voluntad de mantener relaciones sexuales

E.4

Principal exclusion criteria

1 to have received topical hormonal treatment in the last 6 months or Have used vaginal moisturizers and / or lubricants during the 30 days prior to the study treatment
2 to have received treatment with laser, radiofrequency, hyaluronic acid, etc. in the vagina during the last two years at the beginning of the study
3 to Have: an active infection of the genital tract; an intraepithelial neoplasm of the cervix, vagina or vulva; suspected of suffering or having been treated for cancer of the genital tract; suffer a genital prolapse of II degree or greater

1 Haber recibido tratamiento hormonal tópico en los últimos 6 meses o Haber utilizado hidratantes y/o lubricantes vaginales durante los 30 días previos al tratamiento del estudio
2 Haber recibido tratamiento con láser, radiofrecuencia, ácido hialurónico, etc en vagina durante los dos últimos años al inicio del estudio
3 Padecer: una infección activa del tracto genital; una neoplasia intraepitelial de cérvix, vagina o vulva; sospecha de padecer o haber sido tratada por un cáncer del tracto genital; padecer un prolapso genital de II grado o mayor

E.5 End points

E.5.1

Primary end point(s)

Ultrasensitive estradiol plasma levels

Niveles plasmáticos de estradiol ultrasensible

E.5.1.1

Timepoint(s) of evaluation of this end point

Basal, 15 days & months 1, 3, 6

Basal , a los 15 días, al mes y a los meses 3 y 6

E.5.2

Secondary end point(s)

vaginal pH
vaginal cytological sampling to determine the maturational index.
Questionnaires:
Visual Analog Scale (VAS) to assess the symptoms of AVV
Female Sexual Function Index
Quality of life Short Form 12 (SF-12)
Likert scale of satisfaction with treatment: from 0 to 5. 0 indicates that the patient is not at all satisfied with the treatment; 5 indicates maximum satisfaction.

Se realizará una exploración para medición de pH vaginal y toma de muestra citológica vaginal para determinación del índice madurativo de la mucosa.
Asimismo, la paciente rellenará los cuestionarios:
Escala Visual Analógica (VAS) para valorar los síntomas de AVV
Índice de Función Sexual Femenina
Calidad de vida Short Form 12 (SF-12)
Escala de Likert de satisfacción con el tratamiento: se trata de una valoración simple usando una escala de Likert de 0 a 5. 0 indica que la
paciente no está nada satisfecha con el tratamiento; 5 indica la máxima satisfacción.

E.5.2.1

Timepoint(s) of evaluation of this end point

Basal, 15 days & months 1, 3, 6

Basal , a los 15 días, al mes y a los meses 3 y 6

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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

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:

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

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

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.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

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

2020-10-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-10-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-12-30

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