Overview
Sponsor-declared trial summary
Adipositas and male hypogonadism
To investigate the effect and clinical relevance of testosterone therapy combined with exercise and diet counselling in hypogonadal men undergoing bariatric surgery.
Key facts
- Sponsor
- Esbjerg Og Grindsted Sygehus
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 15 Dec 2020 → 6 Nov 2025
- Decision date (initial)
- 2024-09-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517015-73-00
- EudraCT number
- 2018-002365-19
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To investigate the effect and clinical relevance of testosterone therapy combined with exercise and diet counselling in hypogonadal men undergoing bariatric surgery.
Secondary objectives 1
- To evaluate the effect of testosterone therapy combined with exercise and diet counselling on muscle strength, body composition, hormones, components of the metabolic syndrome, inflammation, sexual function, and quality of life after weight loss in obese, hypogonadal men undergoing bariatric surgery.
Conditions and MedDRA coding
Adipositas and male hypogonadism
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Eligible for bariatric surgery according to the Danish national criteria (i.e. aged 18‒60 years, BMI >35 kg/m2 with specific secondary disease or BMI >40 kg/m2 with significant health issues assessed by the multidisciplinary bariatric team) - Caucasian men - Total testosterone < 12.0 nmol/l - No contraindications for testosterone treatment
Exclusion criteria 1
- Previously diagnosed with prostate, mammae or liver cancer. Any other cancer within the last 5 years. - Hypersensitivity to the active substance or to any of the excipients in Nebido® - Symptomatic heart disease NYHA >2 - Recently thromboembolic disease <3 months - PSA >4.0 ug/l or PSA>3.0 ug/l and lower urinary tract symptoms - Disability that severely affect the ability to perform exercise training - EVF > 52% - The following treatments are not allowed in the study:5-α-reductase inhibitors and Prednisolone >5mg/day
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Maximal isometric muscle strength (N) in shoulder muscles (shoulder elevation.
Secondary endpoints 1
- Regional body composition (DXA scan, BMI, Waist/hip-ratio) - Physical strength: maximal isometric muscle strength in lower extremities (hip extension, hip abduction), muscle strength in upper-extremities (shoulder abduction, shoulder adduction) - Physical function: performance-based measures of physical function (stair climb test) and maximal oxygen uptake (VO2max). - Glucose metabolism (HOMA-R, HbA1c, Fasting-P-Blood glucose) - Coagulation/fibrinolysis status (thrombin generation measures) - Ad
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Nebido 1000 mg Injektionslösung
PRD10037761 · Product
- Active substance
- Testosterone Undecanoate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 14.28 mg milligram(s)
- Max total dose
- 11195 mg milligram(s)
- Max treatment duration
- 112 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03BA03 — TESTOSTERONE
- Marketing authorisation
- 60074.00.00
- MA holder
- GRÜNENTHAL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Esbjerg Og Grindsted Sygehus
- Sponsor organisation
- Esbjerg Og Grindsted Sygehus
- Address
- Finsensgade 35
- City
- Esbjerg
- Postcode
- 6700
- Country
- Denmark
Scientific contact point
- Organisation
- Esbjerg Og Grindsted Sygehus
- Contact name
- Line Velling Magnussen
Public contact point
- Organisation
- Esbjerg Og Grindsted Sygehus
- Contact name
- Line Velling Magnussen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, E-data capture, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 64 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2020-12-15 | 2025-11-06 | 2020-12-15 | 2024-01-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protokol | 7 |
| Recruitment arrangements (for publication) | K_recruitment arrangement placeholder | 2 |
| Subject information and informed consent form (for publication) | Deltagerinformation | 5 |
| Subject information and informed consent form (for publication) | Samtykkeerklring | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | Nebido produktresume | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-30 | Denmark | Acceptable 2024-09-19
|
2024-09-20 |