Clinical Trials Register

Summary
EudraCT Number:	2010-020240-35
Sponsor's Protocol Code Number:	FSH
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-12-19
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

Germany - BfArM

A.2

EudraCT number

2010-020240-35

A.3

Full title of the trial

Significance of the FSH receptor polymorphism p.N680S for the efficacy of FSH therapy of idiopathic male infertility: a pharmacogenetic approach.

Significato deI polimorfismo p. N680S deI recettore per FSH neH efficacia della terapia con FSH neH infertilita' maschiIe idiopatica: approccio farmaco genetico.

Der Stellenwert des FSH-Rezeptorpolymorphismus p.N680S für die Wirkung der FSH-Therapie bei idiopathischer männlicher Infertilität: ein pharmakogenetischer Ansatz

A.3.1

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

Evaluation of the FSH therapy efficacy in infertile men of unknown reason depending on two different FSH receptor types.

Evaluierung der FSH-Therapie bei unfruchtbaren Männern mit unbekannter Ursache in Abhängigkeit von zwei verschiedenen FSH-Rezeptortypen.

A.4.1

Sponsor's protocol code number

FSH

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 Modena and Reggio Emilia
B.1.3.4	Country	Italy
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	Merck Serono
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Koordinierungszentrum für Klinische Studien (KKS) Halle
B.5.2	Functional name of contact point	KKS Halle
B.5.3	Address:
B.5.3.1	Street Address	Kiefernweg 34
B.5.3.2	Town/ city	Halle
B.5.3.3	Post code	06120
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4903455574920
B.5.5	Fax number	+4903455575210
B.5.6	E-mail	huemmerich.joerg@kks-halle.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	Yes
D.2.1.1.1	Trade name	GONAL-f 900 I.E./1,5 ml (66 Mikrogramm/1,5 ml) Injektionslösung in einem Fertigpen
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Serono Europe Limited
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	56832-30-5
D.3.9.3	Other descriptive name	FOLLITROPIN ALFA
D.3.9.4	EV Substance Code	SUB12426MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	600
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
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

Ideopathic infertility in men

Idiopathische Unfruchtbarkeit bei Männern

E.1.1.1

Medical condition in easily understood language

Men suffering from infertility of unknown reason

Männer mit Infertilität unbekannter Ursache

E.1.1.2

Therapeutic area

Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10025511
E.1.2	Term	Male infertility, unspecified
E.1.2	System Organ Class	10038604 - Reproductive system and breast disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To investigate if success of FSH therapy in men with idiopathic infertility depends on a specific FSH receptor type (wild type) and if therapy in patients with a specific SNP in FSH receptor is signifcantly more ineffective. This would allow a more targeted therapy for this indication.

E.2.2

Secondary objectives of the trial

Improvement of pregnancy rates in sexual partner

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- age 20-50 years
- idiopathic male factor infertility for at least one year;
- homozygous FSHR allele at codon 680 (wild type: Asn/Asn or Ser/Ser);
- sperm DNA fragmentation index (DFI) > 15%;
- normal serum FSH levels (< 8 IU/L)
- normal serum LH, testosterone, prolactin and estradiol levels
- normal ovulatory female partner

E.4

Principal exclusion criteria

- azoospermia
- all known aetiologies of male infertility (endocrine disorders, genetic disorders, chromosome abnormalities, congenital bilateral absence of the vas deferens, microdeletions within the AZF regions of the Y chromosome, varicocele, cryptorchidism, infections, immunological infertility, and obstructive infertility)
- all known aetiologies of female infertility in the partner (tubal blockage, endocrine abnormalities including anovulation and PCO, anatomical abnormalities, infections)
- heterozygous FSHR allele at codon 680
- drug abuse and major systemic diseases
- testicular insufficiency

E.5 End points

E.5.1

Primary end point(s)

DNA fragmentation index (DFI)

E.5.1.1

Timepoint(s) of evaluation of this end point

Screening
Baseline (start ofr treatment)
After 12 weeks (end of treatment)
After 24 weeks (end of follow up)

E.5.2

Secondary end point(s)

pregnancy in sexual partner, semen parameters, serum levels of inhibin B and AMH

E.5.2.1

Timepoint(s) of evaluation of this end point

pregnancy - any time
semen parameters - screening, 0 weeks, 12 weeks, 24 weeks
serum levesl of inhibin B and AMH - 0 weeks, 12 weeks, 24 weeks

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

Yes

E.6.4

Safety

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

Yes

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

E.8.1.1

Randomised

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

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

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

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

LVLS

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:

100

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

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

100

F.4.2.2

In the whole clinical trial

100

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)

Further treatment following the study is not necessarily mandatory. Possible treatment options doesn't differ from normal standard methods. Patients will be informed and involved in all futher treatment decisions.

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

2012-02-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-12-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-03-24

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