Denosumab and male infertility: A study to investigate how denosumab will influence male reproductive functio
Phase 1
- Conditions
- Male infertility especially low sperm countMedDRA version: 18.0Level: PTClassification code 10021929Term: Infertility maleSystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2015-000655-24-DK
- Lead Sponsor
- rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
men > 18 years with male infertility
sperm concentration > 0.100 million/ml
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
men with chronical illness and serious co-morbidities in need of treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method