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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00858650
Other study ID # RHyMe
Secondary ID
Status Completed
Phase N/A
First received March 9, 2009
Last updated August 22, 2016
Start date March 2009
Est. completion date September 2013

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Other:
Standard of Care
Standard of care may or may not include use of testosterone replacement therapy

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
New England Research Institutes Bayer, Besins Healthcare

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

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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