Testosterone Deficiency Clinical Trial
— RHyMeOfficial title:
Registry of Hypogonadism in Men
Verified date | April 2016 |
Source | New England Research Institutes |
Contact | n/a |
Is FDA regulated | No |
Health authority | European Union: Ethics Committee |
Study type | Observational |
The primary objective of the Registry of HYpogonadism in MEn (RHYME) is to establish and maintain a large, multi-national prospective registry of male patients who have been diagnosed with male hypogonadism (HG), also known as androgen deficiency or testosterone deficiency.
Status | Completed |
Enrollment | 999 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Male patients aged 18 years and older. 2. Diagnosis of hypogonadism including Klinefelter's or late onset HG. Patients may have been diagnosed at any point in their lives. Documentation of the diagnosis of HG (including symptomatology and laboratory values including testosterone levels confirmed on two separate occasions) is required. 3. Written informed consent. Exclusion Criteria: 1. Any previous treatment with testosterone therapy. 2. History of breast cancer, prostate cancer, or high-grade prostatic intraepithelial neoplasia. 3. Prior radical prostatectomy. 4. Life expectancy shorter than 24 months as judged by the Clinical Site investigator. 5. Current major psychiatric disorders or drug or alcohol abuse, which will likely affect participation or compliance in the Registry, in the opinion of the Clinical Site Investigator. 6. Gender dysphoria or sexual reassignment (e.g., transexualism). 7. Patients actively enrolled in any interventional clinical trial. 8. Planned relocation outside Clinical Site region within 24 months. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Halle - Center for Reproductive Medicine and Andrology | Halle (Saale) | |
Germany | Institute of Urology and Andrology, Segeberger Kliniken | Hamburg | |
Germany | Private Practice of Andrology & Urology | Hamburg | |
Germany | Klinik fur Innere Medizin, | Herne | |
Italy | Ospedali Riuniti | Ancona | |
Italy | Unità di Andrologia DFC AziendaOspedalieraUniversitariaCareggi | Florence | |
Italy | Hesperia Hospital | Modena | |
Italy | University of Parma | Parma | |
Italy | University of Rome - Sapienza | Rome | |
Netherlands | Amstelland Hospital | Amstelveen | |
Netherlands | VU medical centre, department of Urology | Amsterdam | |
Netherlands | Andros Men's Health Institutes | Arnhem | |
Netherlands | Erasmus Medical Center - Urology | Rotterdam | |
Spain | Fundacio Puigvert | Barcelona | |
Spain | Hospital Universitario doce de Octubre | Madrid | |
Spain | Hospital Universitario Puerta de Hierro- Majadahonda | Madrid | |
Spain | Hospital Carlos Haya | Malaga | |
Spain | Hospital Virgen del Rocio | Sevilla | |
Sweden | Urohälsan i Skövde: Gotenborg University | Gotenborg | |
Sweden | Karolinska University Hospital - Centre for Andrology and Sexual Medicine | Stockholm | |
United Kingdom | Barnsley Hospital | Barnsley | |
United Kingdom | Royal Free Hospital | Hampstead | |
United Kingdom | Holly Cottage Clinic | Lichfield | |
United Kingdom | Manchester Royal Infirmary | Manchester | |
United Kingdom | Royal Victoria Infirmary | Newcastle |
Lead Sponsor | Collaborator |
---|---|
New England Research Institutes | Bayer, Besins Healthcare |
Germany, Italy, Netherlands, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prostate Cancer | 2-years | Yes | |
Secondary | PSA, IPSS, and Other Urologic Outcomes | 3-years | No | |
Secondary | Sexual Function and Hypogonadism Symptoms | 3-years | No | |
Secondary | Physical Health and Cardiovascular Outcome Measures | 3-years | No |
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