Clinical Trials Register

Summary
EudraCT Number:	2007-007950-77
Sponsor's Protocol Code Number:	OPPTIMUM
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-05-03
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

Sweden - MPA

A.2

EudraCT number

2007-007950-77

A.3

Full title of the trial

Does progesterone prophylaxis to prevent preterm labour improve outcome? - a randomised double blind placebo controlled trial (OPPTIMUM)

Förebyggande behandling med progesteron för att förhindra förtidsbörd - en randomiserad dubbelblind placebo kontrollerad studie (OPPTIMUM)

A.3.1

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

Förebyggande behandling med progesteron för att förhindra förtidsbörd

A.3.2

Name or abbreviated title of the trial where available

OPPTIMUM

A.4.1

Sponsor's protocol code number

OPPTIMUM

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN14568373

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 of Edinburgh and NHS Lothian Health Board
B.1.3.4	Country	United Kingdom
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	MRC
B.4.2	Country	United Kingdom
B.4.1	Name of organisation providing support	Besins Healthcare
B.4.2	Country	European Union
B.4.1	Name of organisation providing support	Hologic
B.4.2	Country	European Union
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University of Edinburgh
B.5.2	Functional name of contact point	Professor Jane Norman
B.5.3	Address:
B.5.3.1	Street Address	QMRI 47 Little France Crescent
B.5.3.2	Town/ city	Edinburgh
B.5.3.3	Post code	EH16 4TJ
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	441312422696
B.5.6	E-mail	jane.norman@ed.ac.uk

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	Utrogestan
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratoires BESINS INTERNATIONAL
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Capsule, soft
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Vaginal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PROGESTERONE
D.3.9.1	CAS number	57-83-0
D.3.9.3	Other descriptive name	micronised progesterone
D.3.9.4	EV Substance Code	SUB10076MIG
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Yes
D.3.11.13.1	Other medicinal product type	Micronised progesterone

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	Capsule, soft
D.8.4	Route of administration of the placebo	Vaginal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Preterm labour

Prematurbörd

E.1.1.1

Medical condition in easily understood language

Förtidsbörd

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

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

In women at high risk of preterm labour, does prophylactic vaginal natural progesterone, 200mg daily from 22 – 34 weeks gestation, compared to placebo:
i.Improve obstetric outcome by lengthening pregnancy and thus reducing the incidence of preterm delivery (before 34 weeks gestation)?
ii.Improve neonatal outcome by reducing a composite of death and major morbidity?
iii.Lead to improved childhood cognitive and neurosensory outcomes at two years?
iv.Represent cost effective management for women at high risk of preterm delivery?

E.2.2

Secondary objectives of the trial

None

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion criteria: High risk for PTB as indicated by: at least one of (i) history of previous PTB/ second trimester loss (ii) previous preterm premature rupture of the fetal membranes (iii) short cervical length (< 25mm) on ultrasound at 18 – 22 weeks gestation. All women will have gestation established by scan at ≤16 weeks.

E.4

Principal exclusion criteria

Exclusion criteria: Known significant structural or chromosomal fetal anomaly; known sensitivity, contraindication or intolerance to progesterone (including peanut allergy); suspected or proven rupture of the fetal membranes at the time of recruitment; multiple pregnancy; prescription or ingestion of medications known to interact with progesterone (eg ketoconazole and ciclosporin).

E.5 End points

E.5.1

Primary end point(s)

•Obstetric:Delivery before 34+0 completed weeks of gestation based on ultrasound.
•Neonatal: Composite outcome of death, brain injury or severe chronic lung disease [61].
•Early childhood: The Bayley III cognitive scale standardised score [62] at two years of chronological age
•Cost effectiveness: Cost per preterm birth, per case of death or serious neonatal morbidity and cost per unit difference in Bayley-III.

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)

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

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.8.3

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

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

last visit of the last subject undergoing the trial

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	Yes
F.1.1.1	In Utero	Yes
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Yes
F.1.1.3	Newborns (0-27 days)	Yes
F.1.1.4	Infants and toddlers (28 days-23 months)	Yes
F.1.1.5	Children (2-11years)	Yes
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	No
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	Yes
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	Yes
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	700
F.4.2	For a multinational trial
F.4.2.1	In the EEA	750

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

2012-06-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-12-31

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