Registry of Hypogonadism in Men

Testosterone Deficiency Clinical Trial

— RHyMe  

Official title:

Registry of Hypogonadism in Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858650
• Other study ID #: RHyMe
• 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

Related Conditions & MeSH terms

• Androgen Deficiency
• Hypogonadism
• Male Hypogonadism
• Testosterone Deficiency

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