Clinical Trials Register

Summary
EudraCT Number:	2016-004034-14
Sponsor's Protocol Code Number:	AOP0975
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-01
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-004034-14

A.3

Full title of the trial

Randomized controlled phase IIb-III clinical trial to assess the effectiveness of different regimens with u-FSH in the infertile male

Studio clinico randomizzato controllato di fase IIb-III per valutare l’efficacia di diversi schemi terapeutici con u-FSH nel maschio infertile

A.3.1

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

Study, with random assignment of treatment, to assess whether different durations and different u-FSH medication dosages produce different results in treating male infertility

Studio con assegnazione casuale del trattamento per valutare se diverse durate e differenti dosaggi di farmaco u-FSH producono differenti risultati nel trattare l'infertilità maschile

A.3.2

Name or abbreviated title of the trial where available

UFO – UROFOLLITROPIN IN OLIGOZOOSPERMIA

A.4.1

Sponsor's protocol code number

AOP0975

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	AZIENDA OSPEDALIERA DI PADOVA
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	IBSA Farmaceutici Italia Srl
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Azienda Ospedaliera di Padova
B.5.2	Functional name of contact point	UOC Andrologia e Medicina della Rip
B.5.3	Address:
B.5.3.1	Street Address	Via Giustiniani, 1
B.5.3.2	Town/ city	Padova
B.5.3.3	Post code	35128
B.5.3.4	Country	Italy
B.5.4	Telephone number	0498218518
B.5.5	Fax number	0498214322
B.5.6	E-mail	andrea.garolla@unipd.it

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	FOSTIMON - 150 UI POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONCINO + 1 FIALA
D.2.1.1.2	Name of the Marketing Authorisation holder	IBSA FARMACEUTICI ITALIA S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	FOSTIMON - 150 UI
D.3.2	Product code	[FOSTIMON- 150 UI]
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	UROFOLLITROPINA (ALTAMENTE PURIFICATA)
D.3.9.2	Current sponsor code	urofollitropina
D.3.9.3	Other descriptive name	urofollitropin (highly purified)
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	Yes
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	FOSTIMON - 150 UI POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONCINO + 1 FIALA
D.2.1.1.2	Name of the Marketing Authorisation holder	IBSA FARMACEUTICI ITALIA S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	FOSTIMON - 150 UI
D.3.2	Product code	[FOSTIMON - 150 UI]
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	UROFOLLITROPINA (ALTAMENTE PURIFICATA)
D.3.9.2	Current sponsor code	urofollitropina
D.3.9.3	Other descriptive name	urofollitropin (highly purified)
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	Yes
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: 3
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	FOSTIMON - 300 UI/1 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE E SOTTOCUTANEO 1 FLACONCINO + 1 SIRINGA PRERIEMPITA CON N.2 AGHI ASSOCIATI
D.2.1.1.2	Name of the Marketing Authorisation holder	IBSA FARMACEUTICI ITALIA S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	FOSTIMON - 300 UI
D.3.2	Product code	[FOSTIMON - 300 UI]
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	UROFOLLITROPINA (ALTAMENTE PURIFICATA)
D.3.9.2	Current sponsor code	urofollitropina
D.3.9.3	Other descriptive name	urofollitropin (highly purified)
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	Yes
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: 4
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	FOSTIMON - 300 UI/1 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE E SOTTOCUTANEO 1 FLACONCINO + 1 SIRINGA PRERIEMPITA CON N.2 AGHI ASSOCIATI
D.2.1.1.2	Name of the Marketing Authorisation holder	IBSA FARMACEUTICI ITALIA S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	FOSTIMON - 300 UI
D.3.2	Product code	[FOSTIMON - 300 UI]
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	UROFOLLITROPINA (ALTAMENTE PURIFICATA)
D.3.9.2	Current sponsor code	urofollitropina
D.3.9.3	Other descriptive name	urofollitropin (highly purified)
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	Yes
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: 5
D.1.2 and D.1.3	IMP Role	Comparator
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	FOSTIMON - 150 UI POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONCINO + 1 FIALA
D.2.1.1.2	Name of the Marketing Authorisation holder	IBSA FARMACEUTICI ITALIA S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	FOSTIMON - 150 UI
D.3.2	Product code	[FOSTIMON - 150 UI]
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	UROFOLLITROPINA (ALTAMENTE PURIFICATA)
D.3.9.2	Current sponsor code	urofollitropina
D.3.9.3	Other descriptive name	urofollitropin (highly purified)
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	Yes
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

Male infertility

Sterilità maschile

E.1.1.1

Medical condition in easily understood language

Male infertility

Sterilità maschile

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10065945
E.1.2	Term	Male sterility
E.1.2	System Organ Class	100000004872

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 verify if the new treatment schemes
proposed in arms 1-3 are able to improve the number of spontaneous pregnancies and pregnancies obtained by medically assisted
procreation techniques (PMA) within 36 weeks from the beginning of the therapy in comparison with the control arm

Verificare se i nuovi protocolli terapeutici proposti nei bracci 1-3 sono in grado di migliorare il numero
di gravidanze spontanee e di gravidanze ottenute mediante tecniche di procreazione medicalmente assistita (PMA) entro 36
settimane dall’inizio del trattamento rispetto al braccio controllo con terapia standard.

E.2.2

Secondary objectives of the trial

To verify, as a result of the different
treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 1. Increased
plasma concentrations of FSH; 2. If at 12 weeks the subjects treated with 300 IU, 3 times a week have on average a Total Motile
Sperm (TMS) higher than that of the subjects treated with a lower dosage (150 IU, 3 times a week) (subjects arm 3 vs arm 1, 2 and
control); 3. At 24 weeks of treatment which of the 4 schemes has a better outcome in terms of average TMS increase and if this
result is higher than the standard one; 4. After 12 weeks after the suspension of treatment, which of the 4 schemes shows an
average of less decrease in TMS and which shows better performance than the standard scheme. 5. Improvement of other seminal
parameters (such as morphology and viability).

Verificare, a seguito dei diversi schemi di trattamento con FSH, a 12 e 24 settimane di terapia e alla
36° settimana (follow-up): 1. Aumento delle concentrazioni plasmatiche di FSH; 2. Se a 12 settimane i soggetti trattati con 300 UI,
3 volte la settimana presentano in media un numero di spermatozoi mobili (TMS) superiore a quello dei soggetti trattati con un
dosaggio inferiore (150 UI, 3 volte la settimana) (soggetti braccio 3 vs braccio 1,2 e controllo); 3. A 24 settimane di trattamento
quale dei 4 schemi presenta un esito migliore in termini di incremento medio di TMS e se tale esito risulti superiore a quello
standard; 4.Dopo 12 settimane dalla sospensione del trattamento quale dei 4 schemi presenta in media un minore decremento di
TMS e quale presenta performance migliori rispetto allo schema standard. 5. Miglioramento di altri parametri seminali (quali
morfologia e vitalità)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Age between 20 and 50 years
- Caucasian Ethnicity
- Oligozoospermia (total sperm count <39 mil / ejaculate)
- Plasma FSH values <8 IU / L
- Normal plasma levels of LH and T
- Normal female fertility and age <40 years.
- Provision of the written informed consent to participation in the study

- Età compresa tra i 20 e i 50 anni
- Etnia caucasica
- Oligozoospermia (numero totale spermatozoi <39 mil/eiaculato)
- Valori di FSH plasmatico <8 UI/L
- LH e T plasmatici normali
- Normale fertilità femminile ed età <40 anni.
- Che rilasciano il consenso informato scritto alla partecipazione allo studio

E.4

Principal exclusion criteria

- Azoospermia
- Endocrine Disorders
- Genetic causes of infertility (chromosomal, microdeletions Cr. Y, CFTR mutations)
- Varicocele, cryptorchidism, infections, presence of antisperm antibodies, obstruction of the seminal ducts
- FSH = 8 IU / L
- Hypogonadism
- Systemic Diseases, testicular tumors
- Known causes of infertility in the partner with obstruction / absence of the tube, endocrine abnormalities, endometriosis, PCOS, oligo-amenorrhea, age = 40 years

- Azoospermia
- Disordini endocrini
- Cause genetiche di infertilità (cromosomiche, microdelezioni del Cr. Y, mutazioni CFTR)
- Varicocele, criptorchidismo, infezioni, presenza di anticorpi antispermatozoo, ostruzione delle vie seminali
- FSH = 8 UI/L
- Ipogonadismo
- Malattie sistemiche, tumori testicolari
- Cause note di infertilità nella partner quali ostruzione/assenza delle tube, anomalie endocrine, endometriosi, PCOS, oligo-amenorrea, età = 40 anni

E.5 End points

E.5.1

Primary end point(s)

To check if the new treatment schemes
proposed in arms 1-3 are able to improve the number of spontaneous pregnancies and pregnancies obtained by medically assisted
procreation techniques (PMA) within 36 weeks from the beginning of the therapy in comparison with the control arm

E.5.1.1

Timepoint(s) of evaluation of this end point

Within 36 weeks from the beginning of therapy

Entro 36 settimane dall'inizio della terapia

E.5.2

Secondary end point(s)

To check, as a result of the different
treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 1. Increased
plasma concentrations of FSH; ): To check, as a result of the different
treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes
2. If at 12 weeks the subjects treated with 300 IU, 3 times a week have on average a Total Motile
Sperm (TMS) higher than that of the subjects treated with a lower dosage (150 IU, 3 times a week) (subjects arm 3 vs arm 1, 2 and
control); To check, as a result of the different
treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 3. At 24 weeks of treatment which of the 4 schemes has a better outcome in terms of average TMS increase and if this
result is higher than the standard one; To check, as a result of the different
treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 4. After 12 weeks after the suspension of treatment, which of the 4 schemes shows an
average of less decrease in TMS and which shows better performance than the standard scheme. ; To check, as a result of the different
treatment schemes with FSH, at 12 and 24 weeks of therapy and at the 36th week (follow-up), the following changes: 5. Improvement of other seminal
parameters (such as morphology and viability)

Verificare, a seguito dei diversi schemi di trattamento con FSH, a 12 e 24 settimane di terapia e alla
36° settimana (follow-up): 1. Aumento delle concentrazioni plasmatiche di FSH; Verificare, a seguito dei diversi schemi di trattamento con FSH, a 12 e 24 settimane di terapia e alla
36° settimana (follow-up): 2. Se a 12 settimane i soggetti trattati con 300 UI,
3 volte la settimana presentano in media un numero di spermatozoi mobili (TMS) superiore a quello dei soggetti trattati con un
dosaggio inferiore (150 UI, 3 volte la settimana) (soggetti braccio 3 vs braccio 1,2 e controllo) ; Verificare, a seguito dei diversi schemi di trattamento con FSH, a 12 e 24 settimane di terapia e alla
36° settimana (follow-up): 3. A 24 settimane di trattamento
quale dei 4 schemi presenta un esito migliore in termini di incremento medio di TMS e se tale esito risulti superiore a quello
standard; Verificare, a seguito dei diversi schemi di trattamento con FSH, a 12 e 24 settimane di terapia e alla
36° settimana (follow-up): 4.Dopo 12 settimane dalla sospensione del trattamento quale dei 4 schemi presenta in media un minore decremento di
TMS e quale presenta performance migliori rispetto allo schema standard.; Verificare, a seguito dei diversi schemi di trattamento con FSH, a 12 e 24 settimane di terapia e alla
36° settimana (follow-up): 5. Miglioramento di altri parametri seminali (quali
morfologia e vitalità)

E.5.2.1

Timepoint(s) of evaluation of this end point

12, 24, 36 weeks; 12 weeks; 24 weeks; 12 weeks; 12, 24, 36 weeks

12, 24, 36 settimane; 12 settimane; 24 settimane; 12 settimane; 12, 24, 36 settimane

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

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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)

Yes

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

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.8.4.1

Number of sites anticipated in 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

Information not present in EudraCT

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:

172

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

172

F.4.2

For a multinational trial

F.4.2.1

In the EEA

172

F.4.2.2

In the whole clinical trial

172

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)

At the end of the study, infertile patients, which showed no hormonal and systemic problems associated with infertility, will be re assigned to the general practitioner.
For patients who, because of testiculopathy, have endocrine-metabolic risk factors, there is a follow-up, at the beginning every six months and then yearly, already provided for normal clinical practice.

Alla fine dello studio, i pazienti infertili che non hanno evidenziato problemi ormonali e sistemici associati all’infertilità saranno riaffidati al medico di medicina generale.
Per i pazienti che a causa della testicolopatia presentano fattori di rischio endocrino-metabolici è previsto un follow-up all’inizio semestrale e successivamente annuale già previsto dalla normale pratica clinica del nostro centro.

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

2017-06-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-11

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

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