Clinical Trials Register

Summary
EudraCT Number:	2020-000790-24
Sponsor's Protocol Code Number:	BEC01
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-04-10
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

Austria - BASG

A.2

EudraCT number

2020-000790-24

A.3

Full title of the trial

BECONTRA - Effects of combined oral contraceptives on brain and behavior

BECONTRA - Einfluss kombinierter oraler Kontrazeptiva auf Gehirn und Verhalten

A.3.1

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

BECONTRA - Effects of combined oral contraceptives on brain and behavior

BECONTRA - Einfluss kombinierter oraler Kontrazeptiva auf Gehirn und Verhalten

A.3.2

Name or abbreviated title of the trial where available

BECONTRA

A.4.1

Sponsor's protocol code number

BEC01

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	Universität Salzburg
B.1.3.4	Country	Austria
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	European Research Council (ERC)
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universität Salzburg
B.5.2	Functional name of contact point	Belinda Pletzer
B.5.3	Address:
B.5.3.1	Street Address	Hellbrunnerstrasse 34
B.5.3.2	Town/ city	Salzburg
B.5.3.3	Post code	5020
B.5.3.4	Country	Austria
B.5.4	Telephone number	004366280445184
B.5.6	E-mail	Belinda.Pletzer@sbg.ac.at

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	Selina Gynial
D.2.1.1.2	Name of the Marketing Authorisation holder	Gynial
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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	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	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	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.03
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVONORGESTREL
D.3.9.1	CAS number	797-63-7
D.3.9.4	EV Substance Code	SUB08483MIG
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	0.15
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	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	Bilinda Gynial
D.2.1.1.2	Name of the Marketing Authorisation holder	Gynial
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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	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	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	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.03
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Chlormadinonacetat
D.3.9.1	CAS number	302-22-7
D.3.9.3	Other descriptive name	CHLORMADINONE ACETATE
D.3.9.4	EV Substance Code	SUB01219MIG
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	2
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

Girls and women 14 years - 35 years, considering the intake of COCs or under current use of EE/LNG or EE/CMA COCs

Mädchen und Frauen im Alter von 14 bis 35 Jahren, die die Einnahme von kombinierten oralen Kontrazeptiva überlegen oder kombinierte orale Kontrazeptiva schon einnehmen

E.1.1.1

Medical condition in easily understood language

Girls and women 14 years - 35 years, considering the intake of COCs or under current use of EE/LNG or EE/CMA COCs

Mädchen und Frauen im Alter von 14 bis 35 Jahren, die die Einnahme von kombinierten oralen Kontrazeptiva überlegen oder kombinierte orale Kontrazeptiva schon einnehmen

E.1.1.2

Therapeutic area

Not possible to specify

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
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.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10010808
E.1.2	Term	Contraception
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	22.0
E.1.2	Level	PT
E.1.2	Classification code	10073728
E.1.2	Term	Hormonal 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

Drug trial on neurocognitive off-target effects of contraceptive drugs

Charakterisierung neurokognitiver Off Target-Effekte von oralen Kontrazeptiva

E.2.2

Secondary objectives of the trial

A secondary objective is to identify predictors of cognitive, emotional and neuronal off target effects of oral contraceptives, among:
- Brain imaging parameters
- Steroid hormone levels
- Genes related to steroid hormone action and neurotransmission

Identifizierung von Prädiktoren neurokognitiver Off Target-Effekte von oralen Kontrazeptiva aus
- ZNS-Bildgebungsparametern
- Steroidhormonkonzentrationnen
- Genetischen Faktoren, die mit der Wirkung von Steroidhormonen und Neurotransmittern assoziiert sind

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Girls and women 14 years - 35 years,
2. considering the intake of COCs or under current use of EE/LNG or EE/CMA COCs, with a
3. regular menstrual cycle for at least 6 months according to the criteria of Fehring et al. (2006) and
4. sufficient German language skills to follow task instructions

1. Alter: 14 years - 35 years
2. Geschlecht: weiblich
3. Interesse an der Einnahme kombinierter oraler Kontrazeptiva
4. Regelmäßiger Menstruationszyklus in den letzten 6 Monaten
5. Ausreichende Deutschkenntnisse zum Verständnis der Aufgaben

E.4

Principal exclusion criteria

Exclusion criteria:
1. Known contra-indication to use of EE/LNG or EE/CMA COCs,
2. diagnosed psychiatric disorder with known effects on cognition or brain structure/function (e.g. schizophrenia, etc.) with the exception of mood disorders
3. diagnosed neurological disorder with known effects on cognition or brain structure/function (e.g. multiple sclerosis, epilepsy, etc.)
4. diagnosed endocrinological disorder deemed clinically significant by the Investigator at screening (e.g. PCOS, Cushing's syndrome, congenital renal hyperplasia)
5. regular intake of medication that might interfere with the conduct of the study or the interpretation of the results (defined below)
6. current pregnancy or previous pregnancies
7. for MR group: contra-indication for MRI
8. for MR group: brain tissue abnormalities on structural MRI as screened by a neuro-radiologist

1. Kontraindikation für die Einnahme der Prüfpräparate
2. diagnostizierte psychiatrische Erkrankung mit bekannten Auswirkungen auf Kognition
oder Gehirnfunktion (z.B. Schizophrenie) mit Ausnahme emotionaler Störungen
3. diagnostizierte neurologische Erkrankung mit bekannten Auswirkungen auf Kognition
oder Gehirnfunktion (z.B. Multiple Sclerose, Epilepsie)
4. diagnostizierte endokrinologische Störung die vom Prüfarzt als klinisch signifikant
eingestuft wird (PCOS, Cushing's Syndrome, Adrenogenitales Syndrom)
5. regelmäßige Einnahme von Medikamenten, die die Studiendurchführung oder
Ergebnisinterpretation beeinflussen könnten
6. bestehende Schwangerschaft oder frühere Schwangerschaft
7. bei MRT: Kontraindikation für eine MRT-Untersuchung
8. bei MRT: Gehirnstrukturelle Auffälligkeiten

E.5 End points

E.5.1

Primary end point(s)

Cognitive, emotional and neuronal off target effects of COC treatment (maximum change from study visit 1 and timepoint of maximum Change)

Kognitive, emotionale und neuronale Nebeneffekte der Einnahme von kombinierten oralen Kontrazeptiva (Maximale Veränderung ab Studienvisite 1 bis zum Zeitpunkt der maximalen Veränderung)

E.5.1.1

Timepoint(s) of evaluation of this end point

18 months

18 Monate

E.5.2

Secondary end point(s)

Predictors of cognitive, emotional and neuronal off target effects of COC treatment, including
- brain imaging parameters
- steroid hormone levels
- genes related to steroid actions or neurotransmissio

Prädiktoren von kognitiven, emotionalen und neuronalen Nebeneffekten bei der Einnahme von kombinierten oralen Kontrazeptiva, einschließlich
-
-
-

E.5.2.1

Timepoint(s) of evaluation of this end point

18 months

18 Monate

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

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

Yes

E.6.13.1

Other scope of the trial description

Drug trial on neurocognitive off-target effects of contraceptive drugs

Charakterisierung neurokognitiver Off Target-Effekte von oralen Kontrazeptiva

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

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Prüfarzt und Auswerter sind verblindet

investigator and rater-blinded

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Keine Therapie

no therapy

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

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 Patient last visit

letzter Patient, letzte Visite

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

Yes

F.1.1

Number of subjects for this age range:

350

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

350

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

250

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 2020-04-10.

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

600

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)

normal treatment

normale Behandlung

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

2020-04-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-07-14

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

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