Clinical Trials Register

Summary
EudraCT Number:	2021-001182-21
Sponsor's Protocol Code Number:	APC-01-2021
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-14
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

2021-001182-21

A.3

Full title of the trial

RANDOMIZED, UNICENTRIC, DOUBLE BLIND, PLACEBO-CONTROLLED TRIAL TO ASSESS THE EFFICACY OF PARACERVICAL ANESTHESIA FOR PAIN CONTROL DURING AN OFFICE HYSTEROSCOPY

ENSAYO CLÍNICO, UNICÉNTRICO, RANDOMIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, PARA EVALUAR LA EFICACIA DE LA ANESTESIA PARACERVICAL PARA EL CONTROL DEL DOLOR DURANTE LA REALIZACIÓN DE LA HISTEROSCOPIA EN CONSULTA

A.3.1

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

TRIAL TO ASSESS THE EFFICACY OF ANESTHESIA DURING OFFICE HYSTEROSCOPY

ESTUDIO PARA EVALUAR LA EFICACIA DE LA ANESTESIA LOCAL DURANTE LA HISTEROSCOPIA EN CONSULTA

A.4.1

Sponsor's protocol code number

APC-01-2021

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 Puerta de Hierro Majadahonda, Madrid, Spain
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	University Hospital Puerta de Hierro Majadahonda, Madrid, Spain
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	University Hospital Puerta de Hierro Majadahonda, Madrid, Spain
B.5.2	Functional name of contact point	LAURA CALLES SASTRE
B.5.3	Address:
B.5.3.1	Street Address	C/Manuel de Falla, 2
B.5.3.2	Town/ city	Majadahonda
B.5.3.3	Post code	28222
B.5.3.4	Country	Spain
B.5.4	Telephone number	34630541332
B.5.6	E-mail	lauracall@hotmail.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	Yes
D.2.1.1.1	Trade name	Mepivacaína
D.2.1.1.2	Name of the Marketing Authorisation holder	NORMON
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	Mepivacaína
D.3.2	Product code	65298
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Infiltration
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MEPIVACAINE
D.3.9.1	CAS number	96-88-8
D.3.9.2	Current sponsor code	65298
D.3.9.3	Other descriptive name	MEPIVACAINE NORMON
D.3.9.4	EV Substance Code	SUB14514MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
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	Solution for injection
D.8.4	Route of administration of the placebo	Infiltration

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Need to do an office Hysteroscopy for any reason

Indicación de realizar una histeroscopia en consulta por cualquier motivo

E.1.1.1

Medical condition in easily understood language

Need to do an hysteroscopy (gynaecologic endoscopy) for any reason

Necesidad de realizar una histeroscopia (endoscopia ginecológica) por cualquier motivo

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10050125
E.1.2	Term	Hysteroscopy
E.1.2	System Organ Class	10022891 - Investigations

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 evaluate pain reduction during an office hysteroscopy by applying paracervical Mepivacaína 2% prior to the procedure

Demostrar la reducción del dolor durante la histeroscopia en consulta tras la aplicación de Mepivacaína 2% a nivel paracervical previo a la prueba.

E.2.2

Secondary objectives of the trial

To evaluate pain caused by the infiltration of Mepivacaína
To evaluate pain during the entrance of the Hysteroscope to the endometrial cavity
To describe the side effects caused by Mepivacaína and the adverse events occured during the office hysteroscopy
To analyze the groups of patients with a higher pain risk and who would benefit more of the appliance of Mepivacaína

Evaluar el dolor derivado de la administración de Mepivacaína 2% paracervical y el dolor durante la entrada del histeroscopio a la cavidad endometrial
Describir los posibles efectos adversos derivados de la administración del fármaco y los acontecimientos adversos que ocurran durante la realización de la histeroscopia.
Analizar los subgrupos de pacientes con un mayor riesgo de dolor durante la prueba, y que potencialmente se beneficien en mayor medida del uso de
Mepivacaína antes de realizar la histeroscopia

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- To be women, over 18 years old, with an indication to perform an office hysteroscopy, either for diagnostic or therapeutic purposes
- Having correctly taken the prescribed premedication consisting of 1 tablet of 10mg Buscopina, an Ibuprofen 600mg or Naproxen 500mg and a Diazepam of 5mg in women weighing less or equal to 70kg or 10mg in women weighing more than 70kg.
- They must be legally competent and able to understand, sign and date the informed consent form.

- Ser mujeres, mayores de 18 años, con indicación de realizar una histeroscopia en consulta, ya sea con fines diagnósticos o terapéuticos
- Haber tomado correctamente la premedicación pautada consistente en 1 compr de Buscapina simple 10mg, un Ibuprofeno 600mg o Naproxeno 500mg y un Diazepam de 5mg en mujeres con peso menor o igual a 70kg o de 10mg en mujeres con peso mayor a 70kg.
- Deben ser jurídicamente competentes y ser capaces de entender, firmar y fechar el formulario de consentimiento informado.

E.4

Principal exclusion criteria

- Women with a history of allergy or intolerance to Mepivacaine or other local anesthetics
- Women with contraindication or inability to collaborate when performing an office hysteroscopy
- Women with a history of chronic pelvic pain or deep endometriosis or carriers of the Essure® device
- Women taking analgesia as a chronic treatment, that is, continuously daily for at least 6 months
- Need to perform any procedure using the Myosure® device
- Inability to understand the nature of the study and give written informed consent.

- Mujeres con historia de alergia o intolerancia a Mepivacaína u otros anestésicos locales
- Mujeres con contraindicación o incapacidad para colaborar a la hora de realizar la histeroscopia en consulta
- Mujeres con antecedentes de dolor pélvico crónico o endometriosis profunda o portadoras del dispositivo Essure®
- Mujeres que tomen analgesia como tratamiento crónico, es decir, de forma continua a diario durante al menos 6 meses.
- Necesidad de realizar durante la prueba algún procedimiento que requiera la utilización del dispositivo Myosure®
- Incapacidad para comprender la naturaleza del estudio y dar su consentimiento informado por escrito.

E.5 End points

E.5.1

Primary end point(s)

The overall pain of the patients will be evaluated during the hysteroscopy in the office using a visual analog pain scale (VAS) scoring from 1 to 10.

Se evaluará el dolor global de las pacientes durante la histeroscopia en consulta utilizando una escala visual analógica del dolor (EVA) puntuando de 1 a 10.

E.5.1.1

Timepoint(s) of evaluation of this end point

This scale will be passed on to the patients at the end of the intervention and the overall pain intensity will be asked.

Esta escala se pasará a la pacientes al final de la intervención y se preguntará por la intensidad de dolor global.

E.5.2

Secondary end point(s)

1. Pain during administration of paracervical anesthesia. The overall pain of the patients will be evaluated using a visual analog pain scale (VAS) scoring from 1 to 10.
2. Pain during entry into the endometrial cavity with the hysteroscope. The global pain of the patients will be evaluated using a visual analogue pain scale (VAS) scoring from 1 to 10.
3. Patient demographic data. The following patient data will be recorded: age, parity (history of childbirth, caesarean section or abortion), if the patient is premenopausal or postmenopausal, previous treatments, surgical history especially curettage or surgeries on the uterine cervix, indication of hysteroscopy, type of hysteroscopy performed (diagnostic or surgical), the duration of the procedure as well as the average pressure needed during it.
4. Side effects derived from the administration of Mepivacaine 2%
5. Adverse events during hysteroscopy

1. Dolor durante la administración de anestesia paracervical. Se evaluará el dolor global de las pacientes utilizando una escala visual analógica del dolor (EVA) puntuando de 1 a 10.
2. Dolor durante la entrada en cavidad con el histeroscopio. Se evaluará el dolor global de las pacientes utilizando una escala visual analógica del dolor (EVA) puntuando de 1 a 10.
3. Características de las pacientes.
Se registrarán los siguientes datos de las pacientes: la edad, la paridad
(antecedentes de partos, cesáreas o abortos), si la paciente es premenopáusica o postmenopáusica, tratamientos previos, antecedentes quirúrgicos especialmente legrados o cirugías sobre el cérvix uterino (conizaciones), la indicación de la histeroscopia, el tipo de histeroscopia realizada (diagnóstica o quirúrgica), el tiempo de la misma así como la presión media a la que se ha trabajado.
4. Efectos adversos derivados de la administración de Mepivacaína 2%
5. Acontecimientos adversos durante la realización de la histeroscopia

E.5.2.1

Timepoint(s) of evaluation of this end point

1. This scale will be passed on to the patients immediately after the administration of the anesthetic
2. This scale will be passed on to patients after the first entry to the
endometrial cavity with the hysteroscope.
3. Before starting the procedure
4 and 5. After finishing the procedure.

1. Esta escala se pasará a las pacientes inmediatamente tras la administración del anestésico
2. Esta escala se pasará a las pacientes tras la primera entrada a la
cavidad endometrial con el histeroscopio.
3. Antes de iniciar el procedimiento
4 y 5. Tras finalizar el procedimiento.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

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

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

Yes

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 histeroscopia realizada a la última paciente incluida en el ensayo clínico

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)

Yes

F.1.3.1

Number of subjects for this age range:

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-06-14.

Yes

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

106

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)

Office hysteroscopy will be performed according to usual practice, so that patients will not need follow-up or treatment other than usual.

La histeroscopia en consulta se realizará según la práctica habitual por lo que las pacientes no necesitarán seguimiento ni tratamiento diferente al habitual.

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

2021-06-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-24

P. End of Trial
P.	End of Trial Status	Ongoing

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