Clinical trial NCT00858650: Registry of Hypogonadism in Men
Official title: Registry of Hypogonadism in Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Male Hypogonadism
Androgen Deficiency
Testosterone Deficiency
Keywords: registry
natural history
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: Bayer
name: Besins Healthcare
First posted: 2009-03-10
Enrollment: 999
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypogonadal men

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prostate Cancer
timeFrame: 2-years
Secondary outcomes:
measure: PSA, IPSS, and Other Urologic Outcomes
timeFrame: 3-years
measure: Sexual Function and Hypogonadism Symptoms
timeFrame: 3-years
measure: Physical Health and Cardiovascular Outcome Measures
timeFrame: 3-years
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: University Hospital Halle - Center for Reproductive Medicine and Andrology
city: Hamburg
country: Germany
facility: Institute of Urology and Andrology, Segeberger Kliniken
city: Hamburg
country: Germany
facility: Private Practice of Andrology & Urology
city: Herne
country: Germany
facility: Klinik fur Innere Medizin,
city: Ancona
country: Italy
facility: Ospedali Riuniti
city: Florence
country: Italy
facility: Unità di Andrologia DFC AziendaOspedalieraUniversitariaCareggi
city: Modena
country: Italy
facility: Hesperia Hospital
city: Parma
country: Italy
facility: University of Parma
city: Rome
country: Italy
facility: University of Rome - Sapienza
city: Amstelveen
country: Netherlands
facility: Amstelland Hospital
city: Amsterdam
country: Netherlands
facility: VU medical centre, department of Urology
city: Arnhem
country: Netherlands
facility: Andros Men's Health Institutes
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center - Urology
city: Barcelona
country: Spain
facility: Fundacio Puigvert
city: Madrid
country: Spain
facility: Hospital Universitario doce de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro- Majadahonda
city: Malaga
country: Spain
facility: Hospital Carlos Haya
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Gotenborg
country: Sweden
facility: Urohälsan i Skövde: Gotenborg University
city: Stockholm
country: Sweden
facility: Karolinska University Hospital - Centre for Andrology and Sexual Medicine
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital
city: Hampstead
country: United Kingdom
facility: Royal Free Hospital
city: Lichfield
country: United Kingdom
facility: Holly Cottage Clinic
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
affiliation: New England Research Institutes, Inc
name: Raymond Rosen, PhD
role: PRINCIPAL_INVESTIGATOR
References: