Clinical Trials Register

Summary
EudraCT Number:	2015-004430-96
Sponsor's Protocol Code Number:	201600107
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-08-29
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

Netherlands - Competent Authority

A.2

EudraCT number

2015-004430-96

A.3

Full title of the trial

Short-term Testosterone replacement in testicular cancer survivors to treat overweight and improve cardiometabolic risk

A.3.1

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

Short-term Testosterone replacement in testicular cancer survivors to treat overweight and improve cardiometabolic risk

A.3.2

Name or abbreviated title of the trial where available

Short-term Testosterone Replacement in Testicular Cancer Survivors

A.4.1

Sponsor's protocol code number

201600107

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 Medical Center Groningen
B.1.3.4	Country	Netherlands
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	Besins Healthcare Benelux
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	University Medical Center Groningen
B.5.2	Functional name of contact point	Principal investigator
B.5.3	Address:
B.5.3.1	Street Address	Hanzeplein 1
B.5.3.2	Town/ city	Groningen
B.5.3.3	Post code	9713 GZ
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31503612821
B.5.5	Fax number	+31503614862
B.5.6	E-mail	j.nuver@umcg.nl

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	No
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	testosterone gel (Androgel)
D.3.2	Product code	testosterone gel (Androgel)
D.3.4	Pharmaceutical form	Gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Transdermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TESTOSTERONE
D.3.9.3	Other descriptive name	transdermal testosterone gel (Androgel)
D.3.9.4	EV Substance Code	SUB10937MIG
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	50
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	Gel
D.8.4	Route of administration of the placebo	Transdermal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Testicular cancer

E.1.1.1

Medical condition in easily understood language

Testicular cancer

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

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

To assess the effects of 20 weeks of treatment with testosterone gel on fat mass as measured using full body dual X-ray absorptiometry (DEXA scan).

E.2.2

Secondary objectives of the trial

To assess the effects of 20 and 40 weeks of treatment with testosterone gel on:
1. abdominal visceral fat mass as measured using full body DEXA scan.
2. clinical parameters of adiposity, including BMI and waist circumference
3. components of the metabolic syndrome, including blood pressure en serum lipids
4. serum levels of androgens and adipocytokines
5. quality of life, sexual health, and androgen deficiency symptoms
6. testicular volume and semen quality
7. bone mass density using DEXA scan and serum bone markers
8. cellular senescence and SASP

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

We will include patients with metastatic testicular cancer after chemotherapy, at least 12 months after completion of last treatment and without evidence of disease. Combination chemotherapy should have contained a platinum compound, either cisplatin or carboplatin. In TC survivors, testosterone levels are routinely measured in blood during follow-up once every two years. Patients are eligible for screening if they are between 18 and 55 years of age, and have a documented low or low-normal total testosterone level ≤14 nmol/L, as measured during any of the follow-up visits, irrespective of signs and symptoms of androgen deficiency. Eligible for actual study participation and randomization between Androgel and placebo will be: survivors of TC not using testosterone supplements, having biochemical evidence of hypogonadism (defined as a serum total testosterone concentration ≤ 12 nmol/L (345 ng/dL) measured after an overnight fast between 8:00 and 10:00 AM), and being overweight (as defined by a BMI ≥ 25 and <35 kg/m2). Patients should be able to understand and abide to the study protocol and sign written informed consent.

E.4

Principal exclusion criteria

We will exclude: patients planning to father children within the next 12 months; patients already treated for hypogonadism, patients taking corticosteroids or hormone replacement other than testosterone with dose-adjustments within the last 3 months prior to randomization; patients taking medication with any antiandrogenic effects (e.g. spironolactone); patients with signs or history of hormone-dependent cancer (prostate or breast cancer); patients with severe lower urinary tract symptoms (as defined by International Prostate Symptom Score >19); patients with a history of coronary artery disease (angina pectoris, myocardial infarction) or heart failure; patients with hematocrit >50%; patients with untreated severe obstructive sleep apnea; patients with uncontrolled hypertension; patients with a BMI > 35 kg/m2; patients with a history of epilepsy; patients with debilitating psychiatric illness or inability to understand the study protocol, according to the opinion of the investigator.

E.5 End points

E.5.1

Primary end point(s)

Main endpoint is the change in fat mass (as expressed in percentage) on full body Dual-Energy X-ray Absorption (DEXA) scan after 20 weeks of treatment with testosterone gel compared with placebo.

E.5.1.1

Timepoint(s) of evaluation of this end point

After 20 weeks of treatment with testosterone gel compared with placebo.

E.5.2

Secondary end point(s)

Secondary end points are changes in the following parameters after 20 and 40 weeks of testosterone treatment compared with placebo:
• Fat mass, visceral abdominal fat and lean mass using DEXA scan
• Prevalence of the metabolic syndrome
• Resting blood pressure
• Muscle strength
• Fasting lipid levels, glucose, insulin, HOMA-index, and HbA1c
• Obesity parameters: BMI, waist circumference, waist-hip ratio, and adipocytokines measured in blood
• Bone metabolism: bone mass density using DEXA scan, and osteocalcin and vitamine D levels in blood
• Hormones of the pituitary-testicular axis
• Testicular volume and semen quality
• Quality of life, sexual health, and androgen deficiency symptoms as assessed using validated questionnaires
• Senescence-marker p16 and SASP measured in blood
• Testicular volume and semen quality
• Quality of life, sexual health, and androgen deficiency symptoms as assessed using validated questionnaires

E.5.2.1

Timepoint(s) of evaluation of this end point

After 20 and 40 weeks of testosterone treatment compared with placebo

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

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)

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

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Open label treatment phase follows double blind phase

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

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

Main endpoint is the change in fat mass (as expressed in percentage) on full body Dual-Energy X-ray Absorption (DEXA) scan after 20 weeks of treatment with testosterone gel compared with placebo.

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

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.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)

Standard treatment

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

2017-08-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-12-11

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

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