Overview
Sponsor-declared trial summary
Male infertility
The aim of this intervention is to investigate whether Denosumab can improve semen quality in a subgroup of infertile men.
Key facts
- Sponsor
- Herlev Hospital
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 1 Apr 2024 → 27 Jan 2025
- Decision date (initial)
- 2023-12-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The aim of this intervention is to investigate whether Denosumab can improve semen quality in a subgroup of infertile men.
Secondary objectives 1
- Differences in clinical pregnancies, reproductive hormones, and differences in semen quality
Conditions and MedDRA coding
Male infertility
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Infertile men >18 years and <60 years of age with reduced sperm production (Sperm concentration <2 mio/mL) - Serum AMH > 30 pmol/L
Exclusion criteria 13
- Men with chronic diseases (diabetes mellitus, thyroid disease, endocrine diseases requirering treatment such as sarcoidosis, tuberculosis, wegeners, vasculitis as well as inflammatory bowel diseases e.g. chron's disease or ulcerative colitis etc)
- Men with active or previous malignant disease
- Sperm cell concentration <0.01 mio/mL
- Men in treatment for osteoporosis
- Serum ionized calcium < 1,18 mmol/L, Total calcium < 2.14 mmol/L or Albumin corrected calcium <2.17 mmol/L
- Serum 25OHD < 25 nmol/L
- eGFR <60 mL/min/1.73m^2
- Poor dental status og dental implants
- Men with obstructive oligospermia (Sperm volume <0.9 mL) or who has been vasectomized
- Latex allergy
- Any case with indication for testis biopsy
- Serum FSH <3 IU/L
- BMI >35 kg/m^2
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Difference in sperm cell concentration (sperm cell concentration millions/mL) between the two groups, evaluted by the semen sample delivered at day 80
Secondary endpoints 5
- Difference in semen quality between the intervention group and the placebo group (total number of sperm cells, and total and percentage of motile, progressive motile and morphological normal sperm cells), evaluated by semen sample delivered at day 80 compared with baseline
- Difference in spontaneous pregnancies before day 180
- Difference in number of spontaneous abortions during the whole trial
- Difference in serum levels of reproductive hormones (FSH, LH, AMH, Inhibin B) at day 80
- Changes in serum levels of reproductive hormones (FSH, LH, AMH, Inhibin B) at day 80 within the groups
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Prolia 60 mg solution for injection in pre-filled syringe
PRD3618671 · Product
- Active substance
- Denosumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 60 mg/ml milligram(s)/millilitre
- Max total dose
- 60 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M05BX04 — -
- Marketing authorisation
- EU/1/10/618/003
- MA holder
- AMGEN EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Herlev Hospital
- Sponsor organisation
- Herlev Hospital
- Address
- Borgmester Ib Juuls Vej 1
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Herlev Hospital
- Contact name
- Martin Blomberg Jensen
Public contact point
- Organisation
- Herlev Hospital
- Contact name
- Mads Joon Jorsal
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 60 | 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 | 2024-04-01 | 2025-01-27 | 2024-04-29 | 2024-12-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| FINAL article for study SUM-100551
|
2025-10-03T09:53:51 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| NAPO lay person results section | 2025-10-03T10:04:56 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay person results NAPO | 1 |
| Summary of results (for publication) | NAPO results published article | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-20 | Denmark | Acceptable 2023-12-19
|
2023-12-19 |