Summary
EudraCT Number:2004-004136-31
Sponsor's Protocol Code Number:EF489-2004/1
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:2006-05-12
Trial results
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2004-004136-31
A.3Full title of the trial
Ensayo clínico para evaluar la eficacia de los suplementos de progesterona natural en la prevención del parto pretérmino gemelar
A.4.1Sponsor's protocol code numberEF489-2004/1
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorLaboratorios Effik, S.A.
B.1.3.4CountrySpain
B.3.1 and B.3.2Status of the sponsor
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Progeffik
D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Effik, S.A.
D.2.1.2Country which granted the Marketing AuthorisationSpain
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameProgeffik
D.3.4Pharmaceutical form Capsule, soft
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPVaginal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNPROGESTERONA NATURAL MICRONIZADA
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number200
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboCapsule, soft
D.8.4Route of administration of the placeboVaginal use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Parto pretérmino en embarazos gemelares
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
evaluar la eficacia de la suplementación con progesterona natural administrada vía vaginal en la prevención del parto pretérmino en gestaciones gemelares.
E.2.2Secondary objectives of the trial
- Evaluar la eficacia de los suplementos de progesterona en embarazos gemelares en:
(a)La dismunición de la tasa de prematuridad severa, estratificando la prematuridad por semanas gestacionales:
û34 – 36 semanas
û32 – 33 semanas
û28 – 31 semanas
û< 28 semanas
(b)Disminución de la necesidad de utilizar tocolíticos durante el embarazo
(c)Comparación del efecto tocolítico de 200 y 400 mg de progesterona natural
(d)Reducción de la tasa de rotura pretérmino de membranas
(e)Mantenimiento de una mayor longitud cervical durante el embarazo
(f) Disminución de la morbimortalidad perinatal

- Evaluar la tolerancia y seguridad del fármaco
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
-Pacientes iguales o mayores de 18 años.
-Embarazo gemelar bicorial biamniótico
-Consentimiento informado de la paciente para participar en el ensayo
E.4Principal exclusion criteria
Embarazo únicos, gemelos monocoriónicos o trillizos.
-Cerclaje profiláctico realizado hasta la semana 14.
-Antecedentes de patología hepática crónica, alteraciones previas de la analítica hepática durante un tratamiento anticonceptivo, o colestasis gestacional en embarazos previos (Magnin et al, 1996; Benifla et al, 1997).
-Alteración basal del perfil analítico hepático.
-Alteración de la función renal.
-Alergia local a la progesterona natural micronizada.
-Patología genital que impida la correcta absorción del medicamento (cervicovaginitis de repetición o sangrados persistentes significativos).
-Inicio del tratamiento después de la semana 20 de gestación.
-Falta de cumplimiento del tratamiento prescrito.
-Anomalía fetal diagnosticada en la ecografia de las 12 y/o 20 semanas de gestación.
-Mujeres consumidoras de sustancias consideradas ilegales
-Mujeres fumadoras de más de 10 cigarros al día
E.5 End points
E.5.1Primary end point(s)
- Tasa de prematuridad global (< 37 semanas) en cada uno de los grupos (se compararán los 3 grupos de tratamiento entre sí, y también el grupo placebo contra el conjunto de los dos grupos con principio activo)
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis Yes
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee Information not present in EudraCT
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
última visita del último paciente reclutado
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years
E.8.9.1In the Member State concerned months12
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Information not present in EudraCT
F.2 Gender
F.2.1Female Yes
F.2.2Male No
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women Yes
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others Information not present in EudraCT
F.4 Planned number of subjects to be included
F.4.1In the member state246
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2005-07-08
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-07-04
P. End of Trial
P.End of Trial StatusCompleted