Clinical Trials Register

Summary
EudraCT Number:	2011-002396-42
Sponsor's Protocol Code Number:	CF111/302
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:	2012-02-29
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

2011-002396-42

A.3

Full title of the trial

A Pivotal, Multicentre, Double-Blind, Double-Dummy, Randomised Trial on the Contraceptive Efficacy, Tolerability and Safety of LF111 (Drospirenone) Over 9 Cycles in Comparison With Desogestrel 0.075 mg

Estudio pivotal, multicéntrico, doble-ciego, doble enmascarado, aleatorizado, para comparar la eficacia contraceptiva, tolerabilidad y seguridad de LF111(Drospirenone) durante 9 ciclos con, desogestrel 0.075mg

A.3.1

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

A clinical study for significant evidence of the contraceptive efficacy, safety and tolerability of Drospirenone (LF111) during 9 cycles at several study sites in comparison with an already marketed pill (drug = desogestrel).

Estudio pivotal para evidenciar la eficacia contraceptiva,seguridad y tolerabilidad de la Drospirenona (LF111) durante 9 cilcos en distintos centros comparado con el fármaco ya comercializado (fármaco= desogestrel)

A.4.1

Sponsor's protocol code number

CF111/302

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	Laboratorios León Farma 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	Laboratorios León Farma S.A.
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	CHEMO France S.A.
B.5.2	Functional name of contact point	Head of Clinical Development Gyna
B.5.3	Address:
B.5.3.1	Street Address	7 rue Victor Hugo
B.5.3.2	Town/ city	Sèvres
B.5.3.3	Post code	92310
B.5.3.4	Country	France
B.5.4	Telephone number	+33149 66 22 26
B.5.5	Fax number	+33141 14 99 17
B.5.6	E-mail	dominique.drouin@chemofrance.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	Drospirenona
D.3.2	Product code	LF111
D.3.4	Pharmaceutical form	Film-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	Drospirenone
D.3.9.1	CAS number	67392-87-4
D.3.9.2	Current sponsor code	LF111
D.3.9.4	EV Substance Code	SUB06413MIG
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	4
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	Cerazette
D.2.1.1.2	Name of the Marketing Authorisation holder	N.V. ORGANON
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.3.1	Product name	Desogestrel
D.3.4	Pharmaceutical form	Film-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	DESOGESTREL
D.3.9.1	CAS number	54024-22-5
D.3.9.3	Other descriptive name	Cerazette
D.3.9.4	EV Substance Code	SUB07003MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	75
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	Film-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	Film-coated 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

Oral hormonal contraceptive for women without uncontrolled current diseases between 18-45 years.

Hormona oral contraceptiva para mujeres sin enfermedades no controladas entre 18-45 años de edad.

E.1.1.1

Medical condition in easily understood language

Oral hormonal contraceptive for healthy women between 18-45 years.

Hormona oral contraceptiva para mujeres sanas entre 18-45 años de edad.

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10030970
E.1.2	Term	Oral contraception
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 demonstrate the contraceptive efficacy of LF111

Demostrar la eficacia contraceptiva de LF111

E.2.2

Secondary objectives of the trial

To demonstrate the safety and tolerability of LF111 in comparison to desogestrel 0.075 mg, especially regarding bleeding pattern.

Para demostrar la seguridad y tolerabilidad de LF111 en comparación con desogestrel 0.075 mg, especialmente en relación con el patrón de sangrado

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Woman without uncontrolled current diseases at risk of pregnancy, at the age of 18-45 years
2. For starters: At least four menstrual cycles during the last six months before Visit 1a were regular (i.e. cycle length between 24 and 35 days)
3. Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg, in sitting position, after 5 minutes of rest
4. Subject agrees to use only IMP for contraception for at least 9 cycles
5. Menstruation restarted since last pregnancy (only applicable for women that were pregnant within the last 6 months), i.e. at least one menstrual cycle after delivery
6. Laboratory values with no deviations of any clinical relevance for the course of the study in the opinion of the investigator
7. Written informed consent given freely after the nature of the trial and disclosure of data has been explained to the subject

1.Mujeres sin enfermedades concurrentes no controladas y con riesgo de embarazo, de 18 a 45 años
2.En el caso de mujeres con inicio de la contracepción hormonal, regularidad en al menos cuatro ciclos menstruales durante los últimos los últimos seis meses antes de la visita 1a (es decir, duración del ciclo comprendida entre 24 y 35 días)
3.Tensión arterial sistólica < 140 mm Hg, tensión arterial diastólica < 90 mm Hg, en sedestación, después de 5 minutos de reposo
4.El sujeto acepta utilizar únicamente los PEI como métodos contraceptivos durante al menos 9 ciclos
5.Reanudación de la menstruación después del último embarazo (solo en el caso de mujeres que, en los últimos 6 meses, hayan estado embarazadas), es decir, mujeres que hayan tenido al menos un ciclo menstrual después del parto
6.Valores analíticos sin desviaciones de relevancia clínica, en opinión del investigador, durante el transcurso del estudio
7.Consentimiento informado por escrito otorgado libremente por el sujeto después de que se le haya explicado naturaleza del estudio y las cuestiones relativas a la divulgación de los datos

E.4

Principal exclusion criteria

1. Pregnant subject
2. Breastfeeding subject
3. Subject is known to or suspected of not being able to comply with the study protocol and the use of the IMPs
4. Abnormal finding on pelvic, breast or intravaginal ultrasound examination that precludes participation in the trial
5. Unexplained amenorrhoea, known polycystic ovary syndrome
6. Subject having ASC-US or more severe finding on Pap smear
7. Known contraindication or hypersensitivity to ingredients (drospirenone, desogestrel) or excipients of IMPs
8. Significant cardiovascular, hepatic or renal disease, diabetes with vascular involvement, uncontrolled thyroid disorder or current venous thrombosis or embolism
9. Undiagnosed vaginal bleeding
10. Known or suspected sex-steroid sensitive malignancies
11. Presence or history of severe hepatic disease as long as liver function values have not returned to normal
12. Evidence or history of alcohol, medication or drug abuse (within the last 12 months)
13. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a
14. Prohibited previous medication / contraceptives
(injectable hormonal methods of contraception within the last 6 months before V1a, progestin-releasing IUD or contraceptive implant within the last 2 months before V1a, anti-retroviral therapy within the last 6 months before V1a, microsomal enzyme-inducing drugs within the last 28 days before the start of IMP intake)
15. Dependence on prohibited co-medication
16. Planned surgery during the anticipated time of participation in this trial requiring withdrawal of an oral contraceptive
17. Regular concomitant use of barrier contraceptive methods, spermicides, IUDs or other contraceptive measures (excepting occasional use due to risk of infection)
18. Evidence or history of neurotic personality, psychiatric illness or suicide risk
19. Participation in another trial of investigational drugs or devices parallel to, or less than 90 days before trial entry, or previous participation in this trial
20. Employee of the investigator or trial centre or family member of the employees or the investigator
21. Any condition that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol

1. Mujer embarazada
2.Mujer en periodo de lactancia
3.Se sabe o se sospecha que el sujeto no podrá cumplir con el protocolo del estudio y el uso del PEI
4.Resultado anómalo en una exploración ecográfica ginecológica, mamaria o intravaginal que impide la participación del sujeto en el estudio
5.Amenorrea idiopática, síndrome del ovario poliquístico conocido
6.Sujeto con células escamosas atípicas de significado indeterminado (ASC-US) o resultado de mayor gravedad en citología cervicovaginal
7.Contraindicación o hipersensibilidad conocidas a los principios activos (drospirenona, desogestrel) o los excipientes de los PEI.
8.Enfermedad cardiovascular, hepática o renal significativas; diabetes con afectación vascular; trastorno tiroideo no controlado o trombosis venosa o embolia concurrentes
9.Sangrado vaginal no diagnosticado
10.Neoplasias malignas confirmadas o posibles con sensibilidad a hormonas esteroideas sexuales
11.Presencia o antecedentes de hepatopatía grave mientras los valores de la función hepática no vuelvan a la normalidad
12.Presencia o antecedentes de alcoholismo, drogodependencia o farmacodependencia (en los 12 últimos meses)
13.Trastorno hemorrágico confirmado o antecedentes de hemorragia o equimosis idiopática en los últimos 12 meses previos a la visita V1a
14.Medicamentos previos/contraceptivos no permitidos (métodos contraceptivos hormonales inyectables en los últimos 6 meses antes de la visita V1a, DIU o implante contraceptivo liberador de progestina en los últimos 2 meses antes de la visita V1a, tratamiento antirretroviral en los últimos 6 meses antes de la visita V1a, fármacos inductores de las enzimas microsomales en los últimos 28 días antes de comenzar la toma de los PEI)
15.Dependencia de medicamentos prohibidos
16.Intervención quirúrgica programada que se realizará durante el periodo de participación en este estudio y que exigirá la suspensión de la contracepción oral
17.Uso concomitante habitual de métodos contraceptivos de barrera, espermicidas, DIU u otros métodos contraceptivos (salvo uso ocasional debido a riesgo de infección)
18.Signos o antecedentes de personalidad neurótica, enfermedad psiquiátrica o riesgo de suicidio
19.Participación en otro estudio sobre medicamentos o dispositivos en estudio simultáneamente o en los 90 días previos a la admisión en este estudio o participación previa en este estudio
20.Empleado del investigador o del centro del estudio o familiar de los empleados o del investigador
21.Cualquier situación que, en opinión del investigador, pueda poner en peligro la realización del estudio conforme al protocolo

E.5 End points

E.5.1

Primary end point(s)

Overall Pearl Index (overall PI)

El índice de Pearl global (IP global)

E.5.1.1

Timepoint(s) of evaluation of this end point

After study termination (last patient/last visit)

Después de la terminación del estudio (el último paciente / la última visita)

E.5.2

Secondary end point(s)

- Pearl Index for method failures
- Pearl Index after correction for back-up contraception
- Pregnancy ratio
- safety and tolerbility endpoints

-El IP para los fallos del método contraceptivo
-El IP tras corrección por el uso simultáneo de otro método contraceptivo
-El porcentaje de embarazos
-Criterios de seguridad y tolerabilidad

E.5.2.1

Timepoint(s) of evaluation of this end point

After study termination (last patient/last visit)

Después de la terminación del estudio (el último paciente / la última visita)

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)

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

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 this trial is defined as the date of the last visit of the last patient (LPLV) undergoing this trial.

El final de este ensayo se define como la fecha de la última visita del último paciente (LPLV) sometido a este estudio

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:

1200

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

Yes

F.3.2

Patients

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 2012-02-29.

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

360

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1200

F.4.2.2

In the whole clinical trial

1200

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)

After the last intake of IMP, the investigator will arrange for the subjects further contraceptive treatment, as needed. If possible, consecutive hormonal contraceptives should be started only after all V5/EDV assessments have been performed.

Después de tomar la última dosis de PEI, el investigador dispondrá el tratamiento contraceptivo siguiente del sujeto, según sea necesario. Si es posible, el uso consecutivo de contraceptivos hormonales solo se iniciará después de que se hayan realizado todas las evaluaciones de la V5/EDV

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

2012-04-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-01-27

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