Clinical Trials Register

Summary
EudraCT Number:	2011-005573-23
Sponsor's Protocol Code Number:	2914-015
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:	2012-01-19
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

2011-005573-23

A.3

Full title of the trial

A prospective, randomized, double-blind parallel-arm, placebo-controlled study to assess the effects on ovarian activity of a combined oral contraceptive pill when preceded by the intake of ellaOne® (ulipristal acetate 30 mg) or placebo

A.3.1

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

Not applicable

A.3.2

Name or abbreviated title of the trial where available

Not applicable

A.4.1

Sponsor's protocol code number

2914-015

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	Laboratoire HRA Pharma
B.1.3.4	Country	France
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	No
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	Chalmers Sexual Health Clinic
B.5.2	Functional name of contact point	Dr Sharon Cameron
B.5.3	Address:
B.5.3.1	Street Address	2a Chalmers Street
B.5.3.2	Town/ city	Edinburgh
B.5.3.3	Post code	EH3 9ES
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	00441313325474
B.5.5	Fax number	00441313322931
B.5.6	E-mail	sharon.cameron@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	ellaOne
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratoire HRA Pharma
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	ellaOne
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	Ulipristal acetate
D.3.9.1	CAS number	126784-99-4
D.3.9.2	Current sponsor code	VA2914 – CDB-2914
D.3.9.3	Other descriptive name	ULIPRISTAL ACETATE
D.3.9.4	EV Substance Code	SUB30470
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	30
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	Microgynon 30
D.2.1.1.2	Name of the Marketing Authorisation holder	Bayer plc
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.3.1	Product name	Microgynon
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	levonorgestrel
D.3.9.1	CAS number	797-63-7
D.3.9.2	Current sponsor code	LNG
D.3.9.3	Other descriptive name	LEVONORGESTREL
D.3.9.4	EV Substance Code	SUB08483MIG
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.3.9.2	Current sponsor code	Not known
D.3.9.3	Other descriptive name	Not known
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	30
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	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

Contraception

E.1.1.1

Medical condition in easily understood language

Not applicable

E.1.1.2

Therapeutic area

Body processes [G] - Metabolic Phenomena [G03]

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

The primary objective of the study is to compare the effects of quick starting a Combined Oral Contraceptive Pill (COCP) on follicular growth and hormonal parameters after ellaOne® or placebo intake.

E.2.2

Secondary objectives of the trial

The secondary objective of the study is to compare the effects of quick starting a COCP on menstrual bleeding patterns and tolerability after ellaOne® or placebo intake

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Healthy women aged 18-35 years old
•BMI < 30 Kg/m2
•Not at risk of pregnancy:
-not sexually active,
-willing to protect all further acts of intercourse with condoms until last study visit, or
-partner sterilized or vasectomized
•No use of progesterone-only-pill for 3 months before start of treatment cycle
•No use of implant hormonal contraception for 3 months before start of treatment cycle
•No use of levonorgestrel intrauterine system for 3 months before start of treatment cycle
•No use of depo provera for 12 months before start of treatment cycle
•Women must be able to and willing to give voluntary, written informed consent to participate in the study, and must agree to observe all study requirements

E.4

Principal exclusion criteria

•Pregnant (positive urinary pregnancy test) or less than 4 weeks postpartum
•Currently breastfeeding
•Current use of an intra-uterine device (IUD)
•Use of any other hormonal contraception than the study medication during the treatment cycle
•Irregular menstrual cycles (before the onset of the contraceptive method for women under hormonal contraception at screening visit)
•Follicle-like structure (FLS) >13mm observed on transvaginal ultrasound (TVU) performed at baseline visit
•Dominant follicle size ≤13mm observed on TVU at day 18 (+/- 1 day) during the pre-treatment period
•Last Pap smear performed was abnormal (high-grade squamous intra-epithelial lesions or higher)
•Suspected hyperplasia or carcinoma of the endometrium
•Cancer (past history of any carcinoma or sarcoma)
•Known or suspected alcoholism or drug abuse
•Known abnormal thyroid status
•Chronic treatment with oral glucocorticoids
•Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
•Known hypersensitivity to the ingredients of the test active substances or excipients namely, lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate, maize starch, macrogol, calcium carbonate, glycerol, titanium dioxide, yellow ferric oxide pigment, montan glycol wax, talc
•Any contraindications to Microgynon 30® (per SPC) other than already listed (known hypertension (adequately controlled) or current elevated blood pressure >140/90; migraine with aura; current or history of confirmed venous thromboembolism; current or previous arterial thrombotic or embolic processes; known thrombogenic mutations; diabetes mellitus with vascular changes; sickle-cell anaemia; severe disturbances of liver function, active current hepatitis, previous or existing liver tumours; jaundice or persistent itching during a previous pregnancy; Dubin-Johnson syndrome; rotor syndrome; current or medically treated gallbladder disease; disorders of lipid metabolism; history of herpes gestationis, deterioration of otosclerosis during pregnancy)
•Concomitant use of medication thought to interact with ellaOne® or COCP during study participation
-Oral antidiabetics or insulin
-Concomitant use of the PGP substrates during study participation (e.g. alpha-methyldigoxin, amitriptyline, beta-acetyldigoxin, carbamazepine, cetirizine, chlorpromazine, citalopram, digoxin, doxepine, fexofenadine, glyburide, LAAM (Levo-Alpha Acetyl Methadol), morphine, nortriptyline, olanzapine, ondansetron, paroxetine, pentazocaine, phenobarbital, phenytoin, quetiapine, risperidone, sertraline, terfenadine, topiramate, trimipramine and venlafaxine)
-Concomitant use of liver enzyme inducers (e.g. rifampicin, phenytoin, Phenobarbital, carbamazepine, ritonavir, St John’s wort/ Hypericum perforatum) during study participation
-Concomitant use of potent liver enzyme inhibitors (e.g. ketoconazole, itraconazole, telithromycin, clarithromycin, nefazodone) during study participation
-Concomitant administration of medicinal products that increase gastric pH (e.g. proton pump inhibitors, antacids and H2-receptor antagonists) during study participation
•Current participation in any other trial of an investigational medicine or participation in the past three months before start of treatment cycle

E.5 End points

E.5.1

Primary end point(s)

•Proportion of subjects with a Hoogland score consistent with ovarian quiescence (≤3) after 1 to 21 days of intake of COCP in both groups (preceded by the intake of ellaOne® or placebo).
•Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score ≤3) after the intake of ellaOne® or placebo.

E.5.1.1

Timepoint(s) of evaluation of this end point

Hoogland scores will be calculated after 1 to 21 days of intake of COCP in both groups (preceded by the intake of ellaOne® or placebo).

E.5.2

Secondary end point(s)

•Bleeding patterns during the intake of COCP, when started on the day after the intake of ellaOne® or placebo.
•Description and frequencies of adverse events.

E.5.2.1

Timepoint(s) of evaluation of this end point

Bleeding patterns and adverse events will be collected throughout the study

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)

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

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)

E.8.2.2

Placebo

Yes

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

Yes

E.8.4

The trial involves multiple sites in the 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 subject last visit

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:

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Investigators should discuss contraceptive methods with participating subjects and propose them the most adapted method.

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

2012-02-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-08-31

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