Clinical Trials Register

Summary
EudraCT Number:	2011-002602-78
Sponsor's Protocol Code Number:	DSG-HSP-201
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-11-25
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-002602-78

A.3

Full title of the trial

A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of DR-102 Compared to a 28-day Standard Oral Contraceptive Regimen, on Hemostatic Parameters in Healthy Women.

Studio multinazionale, multicentrico, randomizzato, in aperto per valutare l'impatto di DR-102 rispetto a un regime contraccettivo orale standard di 28 giorni, sui parametri emostatici in donne sane.

A.3.1

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

A clinical research study to evaluate the impact of the experimental birth control drug on hemostatic parameters (characteristics of the blood) compared to a standard marketed birth control pill in healthy women.

Studio clinico per valutare l'impatto di un contraccettivo orale sperimentale sui parametri emostatici in confronto con un contraccettivo orale standard in commercio in donne sane.

A.4.1

Sponsor's protocol code number

DSG-HSP-201

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	TEVA WOMEN'S HEALTH RESEARCH&DEVELOPMENT, A DIVISION OF TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.
B.1.3.4	Country	United States
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	Teva Women's Health Research, a Division of Teva Branded Pharmaceutical Products R&D, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Teva Pharma GmbH
B.5.2	Functional name of contact point	Clinical Trial Information Desk
B.5.3	Address:
B.5.3.1	Street Address	Waldecker Str. 7
B.5.3.2	Town/ city	Moerfelden-Walldorf
B.5.3.3	Post code	64546
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49 6105 000000
B.5.5	Fax number	+49 6105 000000
B.5.6	E-mail	Info.era-clinical@teva.de

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.3.2	Product code	DR-102
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	54024225
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	150
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ETHINYLESTRADIOL
D.3.9.1	CAS number	57-63-6
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ETHINYLESTRADIOL
D.3.9.1	CAS number	57-63-6
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	10
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	MERCILON*21CPR 0,15MG+0,02MG
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	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	DESOGESTREL
D.3.9.1	CAS number	54024225
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	150
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ETHINYLESTRADIOL
D.3.9.1	CAS number	57-63-6
D.3.9.4	EV Substance Code	SUB07277MIG
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	20
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

The impact of an experimental birth control drug on hemostatic parameters (characteristics of the blood) compared to a standard marketed birth control pill in healthy women (contraceptive).

Lo studio vuole valutare l'impatto di un farmaco sperimentale per il controllo delle nascite sui parametri emostatici in donne sane rispetto a un regime contraccettivo orale standard in commercio.

E.1.1.1

Medical condition in easily understood language

The impact of an experimental birth control drug on hemostatic parameters (characteristics of the blood) compared to a standard marketed birth control pill in healthy women (birth control).

Valutazione dell'impatto di un farmaco sperimentale per il controllo delle nascite sui parametri emostatici in donne sane rispetto a un regime contraccettivo orale standard in commercio

E.1.1.2

Therapeutic area

Health Care [N] - Population Characteristics [N01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
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

The purpose of the stuy is to evaluate hemostatic parameters for the contraceptive regimen DR-102 (Treatment I) compared to a active comparator.

Lo scopo di questo studio e' di valutare i parametri emostatici per il regime contraccettivo DR-102 (Trattamento I) rispetto a un farmaco attivo di confronto.

E.2.2

Secondary objectives of the trial

none

nessuno

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

I.1 Female subjects 18-40 years of age, inclusive, at the time of consent; I.2 Premenopausal, non-pregnant, and not breast-feeding for a period of 2 months prior to the Screening visit; I.3 Body Mass Index (BMI) ≥ 18 kg/m2 and < or equal 30 kg/m2; I.4 One spontaneous menstrual cycle (that occurs approximately 23-35 days after previous menses or withdrawal bleeding episode) prior to or concurrent with the Screening Period; I.5 Willing to be randomized to one of two open-label oral contraceptive treatment regimens and willing to adhere to the randomized treatment regimen for the 6-month study period; I.6 Not at risk for pregnancy or willing and able to use an effective method of non-hormonal contraception (non-hormone releasing IUD, diaphragm, spermicidal foam, contraceptive sponge, condoms) from the time of signed informed consent through last dose of IMP; I.7 Able to complete all study procedures; capable of and willing to be present at the study site for all study visits; and I.8 Able and willing to read, understand and sign an informed consent after the nature of the study has been fully explained.

I.1 Donne di eta' compresa fra 18 e 40 anni, inclusi, al momento della firma del consenso; I.2 In pre-menopausa, non in gravidanza e non in allattamento nei 2 mesi precedenti la visita di Screening; I.3 Indice di massa corporea (Body Mass Index, BMI) ≥ 18 kg/m2 e ≤ 30 kg/m2; I.4 Un ciclo mestruale spontaneo (che si verifica circa 23-35 giorni dopo la precedente mestruazione o episodio di sanguinamento da privazione) prima o in concomitanza con il periodo di screening; I.5 Disponibilita' ad accettare la randomizzazione in uno dei due regimi di trattamento contraccettivo orale in aperto e disponibilita' ad attenersi al regime del trattamento asssegnato per il periodo di studio di 6 mesi; I.6 Donne non a rischio di gravidanza o disponibilita' e capacita' di utilizzare un efficace metodo di contraccezione non ormonale (dispositivo intrauterino non a rilascio ormonale, diaframma, schiuma spermicida, spugna contraccettiva, profilattico) dal momento della firma del consenso informato fino all’ultima dose di farmaco in studio; I.7 Capacita' di completare tutte le procedure dello studio; possibilita' e disponibilita' di recarsi al centro per tutte le visite dello studio; e I.8 Capacita' e disponibilita' di leggere, comprendere e firmare un consenso informato dopo che la natura dello studio e' stata spiegata in ogni dettaglio.

E.4

Principal exclusion criteria

E.1 Any condition (history or presence of) which contraindicates the use of combination oral contraceptives:  Thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders;  Migraine headaches with focal, neurological symptoms;  Cerebrovascular or coronary artery disease or myocardial infarction;  Diabetes mellitus;  Chronic renal disease;  Uncontrolled or untreated hypertension;  Cholestatic jaundice;  Major surgery with prolonged immobilization (current or scheduled);  Known or suspected carcinoma of the breast, endometrial carcinoma or known or suspected estrogen dependent neoplasia; Undiagnosed abnormal genital bleeding;  Impaired liver function or disease, hepatic adenomas or carcinomas;  Known or suspected pregnancy; E.2 Concomitant use of sex hormones including over-the-counter estrogenic compounds/nutritional supplements or food products with estrogenic or potential estrogenic activity within 30 days prior to the Screening Visit; E.3 Any history of, or current deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease; E.4 Venous thromboembolic event at age 40 or younger in a parent or sibling of subject; E.5 Acute or chronic severe liver dysfunction or disease. There should be an interval of at least 6 months between subsidence of a viral hepatitis and the start of the IMP; E.6 Within 2 months postpartum or post-abortion at the Screening Visit; E.7 Smoker and age ≥ 35 years at the time of the Screening visit, or smokers who will become 35 while taking the IMP; E.8 History of a previous clinically significant adverse event while taking hormonal contraceptives that controindicates the use of hormonal contraceptives; E.9 History of having received injectable hormone therapy (e.g. Depo-Provera) within the 6 months prior to the Screening Visit or has a contraceptive implant in place at the time of the Screening Visit; E.10 Use of any medication, which could significantly interfere with study assessments or with the efficacy of oral contraceptives within 30 days prior to the Screening Visit; E.11 Known hypersensitivity or previous intolerance to estrogens and/or progestins; E.12 Any clinically significant Pap result that would necessitate further evaluation by biopsy; E.13 History of noncompliance with taking medication(s); E.14 Known or suspected alcohol or drug abuse within 12 months prior to the Screening Visit; E.15 Use of any experimental drug or device within 30 days prior to the Screening Visit; E.16 Known human immunodeficiency virus (HIV) and/or Hepatitis C positive status; E.17 Any employee or relative of an employee of the Sponsor, any Investigator Site employee or relative of employees working on the study; E.18 Any abnormal finding or condition deemed clinically significant by the Investigator or Sponsor on history, screening, physical exam, or clinical laboratory analysis that contraindicates the use of oral contraceptives; or E.19 Any condition or finding the Investigator or Sponsor believes would interfere with the subject’s ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at risk.

E.1 Qualunque condizione medica (in anamnesi o attuale) che controindichi l`utilizzo di contraccettivi orali combinati:• Tromboflebite o disturbi tromboembolici; disturbi della coagulazione noti o presunti; valvulopatie o disturbi del ritmo trombogenici;• Emicranie con sintomi neurologici focali;• Malattia cerebrovascolare o malattia arterio-coronarica o infarto del miocardio;• Diabete mellito;• Malattia renale cronica;• Ipertensione non controllata o non trattata;• Ittero colecistico; •Importante intervento chirurgico con immobilizzazione prolungata (attuale o programmato);• Carcinoma del seno noto o presunto, carcinoma dell`endometrio o neoplasia estrogeno-dipendente nota o presunta;• Sanguinamento genitale anormale non diagnosticato;• Funzionalita' epatica compromessa o malattia epatica, adenomi o carcinomi epatici;• Gravidanza nota o presunta; E.2 Impiego concomitante di ormoni sessuali inclusi composti estrogeni/integratori nutrizionali da banco o prodotti alimentari con attivita' estrogena, o con potenziale attivita' estrogena nei 30 giorni precedenti la visita di screening; E.3 Trombosi venosa profonda, embolia polmonare o malattia tromboembolica arteriosa in anamnesi o attuale; E.4 Evento tromboembolico venoso all`eta' di 40 anni o prima, in un genitore o in un fratello/sorella del soggetto; E.5 Disfunzione o malattia epatica grave acuta o cronica. Deve trascorrere un periodo di almeno 6 mesi fra l`abbassamento della carica virale di un`epatite e l`inizio dell`assunzione del farmaco in studio; E.6 Alla visita di screening il periodo trascorso dopo un parto o un aborto deve essere inferiore a 2 mesi; E.7 Fumatrice e con eta' ≥ 35 anni al momento della visita di screening, o fumatrici che compiranno 35 anni durante il periodo di trattamento con il farmaco in studio; E.8 Anamnesi di un precedente evento avverso clinicamente significativo occorso durante l`assunzione di contraccettivi ormonali, che controindichi l’uso di contraccettivi ormonali; E.9 Anamnesi di somministrazione di terapia ormonale iniettabile (es. Depo-Provera) nei 6 mesi precedenti la visita di screening o presenza di impianto contraccettivo al momento della visita di screening; E.10 Uso di qualsiasi farmaco che potrebbe interferire significativamente con le valutazioni dello studio o con l`efficacia dei contraccettivi orali nei 30 giorni precedenti la visita di screening; E.11 Ipersensibilita' nota o precedente intolleranza a estrogeni e/o progestinici; E.12 Qualunque risultato di Pap test clinicamente significativo che richieda ulteriore valutazione tramite biopsia; E.13 Anamnesi di non compliance nell`assunzione dei farmaci; E.14 Abuso noto o presunto di alcol o droghe nei 12 mesi precedenti la visita di screening; E.15 Uso di qualsiasi farmaco o dispositivo sperimentale nei 30 giorni precedenti la visita di screening; E.16 Condizione nota di positivita' per virus da immunodeficienza acquisita (HIV) e/o epatite C; E.17 Qualunque dipendente o parente di un dipendente dello Sponsor, qualunque dipendente o parente di un dipendente del centro di sperimentazione che lavora allo studio; E.18 Qualsiasi risultato o condizione anormale considerato clinicamente significativo dallo sperimentatore o dallo Sponsor relativamente all`esame anamnestico, allo screening, all’esame obiettivo generale o alle analisi cliniche di laboratorio che controindichi l`utilizzo di contraccettivi orali; o E.19 Qualsiasi risultato o condizione che lo sperimentatore o lo Sponsor ritengano possa interferire con la capacita' del soggetto di fornire il consenso informato e con l’attenersi alle istruzioni dello studio, o che potrebbe alterare l`interpretazione dei risultati dello studio o mettere in pericolo il soggetto.

E.5 End points

E.5.1

Primary end point(s)

The primary endopoint is the change from baseline in Prothrombin Fragment 1+2 levels over the 6-month treatment period.

L’endpoint primario e' la variazione dei livelli del Frammento di Protrombina 1+2 dal basale al mese 6.

E.5.1.1

Timepoint(s) of evaluation of this end point

Change from baseline at week 11 and 23

Variazione dal basale alle visite settimana 11 e settimana 23

E.5.2

Secondary end point(s)

Secondary endpoints: the change from baseline in the following secondary endpoints: - D-dimer, APTT and ETP based APC resistance, Factor II, Factor VII, Factor VIII, Antithrombin, Protein C and Free and total Protein S; - Total Cortisol and Corticosteroid Binding Globulin (CBG); - Thyroid Stimulating Hormone (TSH); - Sex Hormone Binding Globulin (SHBG).

Variazione dal basale al mese 6 di trattamento nei seguenti endpoints secondari: • D-dimero, resistenza alla proteina C attivata (APC) basata su APTT e potenziale endogeno di trombina (ETP), Fattore II, Fattore VII, Fattore VIII, Antitrombina, Proteina C, e Proteina S libera e totale, • cortisolo totale e globulina legante i corticosteroidi (CBG), • ormone tireostimolante (TSH), e • globulina legante gli ormoni sessuali (SHBG).

E.5.2.1

Timepoint(s) of evaluation of this end point

Change from baseline at week 11 and 23

Variazione dal basale alle visite settimana 11 e settimana 23

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

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

Israel

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

Final telephone contact done 14 days following the last dose of the study medication.

ultimo contatto telefonico 14 giorni dopo l'ultima dose di farmaco in studio.

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

Number of subjects for this age range:

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:

240

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

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

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

180

F.4.2.2

In the whole clinical trial

240

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)

standard birth care control

metodo contraccettivo standard per il controllo delle gravidanze

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

2011-07-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-07-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-09-06

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Clinical trials