Registry of Hypogonadism in Men (RHyMe)
This study is ongoing, but not recruiting participants.
Sponsor:
New England Research Institutes
Collaborator:
Bayer
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00858650
First received: March 9, 2009
Last updated: October 18, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Male Hypogonadism Androgen Deficiency Testosterone Deficiency |
Other: Standard of Care |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Registry of Hypogonadism in Men |
Further study details as provided by New England Research Institutes:
Primary Outcome Measures:
- Prostate Cancer [ Time Frame: 2-years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- PSA, IPSS, and Other Urologic Outcomes [ Time Frame: 2-years ] [ Designated as safety issue: No ]
- Sexual Function and Hypogonadism Symptoms [ Time Frame: 2-years ] [ Designated as safety issue: No ]
- Physical Health Outcome Measures [ Time Frame: 2-years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | March 2009 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Standard of Care
Hypogonadal males treated by standard of care, with or without testosterone replacement therapy
|
Other: Standard of Care
Standard of care may or may not include use of testosterone replacement therapy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Hypogonadal men
Criteria
Inclusion Criteria:
- Male patients aged 18 years and older.
- 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.
- Written informed consent.
Exclusion Criteria:
- Any previous treatment with testosterone therapy.
- History of breast cancer, prostate cancer, or high-grade prostatic intraepithelial neoplasia.
- Prior radical prostatectomy.
- Life expectancy shorter than 24 months as judged by the Clinical Site investigator.
- 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.
- Gender dysphoria or sexual reassignment (e.g., transexualism).
- Patients actively enrolled in any interventional clinical trial.
- Planned relocation outside Clinical Site region within 24 months.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858650
Locations
| Germany | |
| University Hospital Halle - Center for Reproductive Medicine and Andrology | |
| Halle (Saale), Germany | |
| Private Practice of Andrology & Urology | |
| Hamburg, Germany | |
| Institute of Urology and Andrology, Segeberger Kliniken | |
| Hamburg, Germany | |
| Klinik fur Innere Medizin, | |
| Herne, Germany | |
| 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, Italy | |
| 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, Netherlands | |
| Spain | |
| Fundacio Puigvert | |
| Barcelona, Spain | |
| Hospital Universitario Puerta de Hierro- Majadahonda | |
| Madrid, Spain | |
| Hospital Universitario doce de Octubre | |
| Madrid, Spain | |
| Hospital Carlos Haya | |
| Malaga, Spain | |
| Hospital Virgen del Rocio | |
| Sevilla, Spain | |
| Sweden | |
| Urohälsan i Skövde: Gotenborg University | |
| Gotenborg, Sweden | |
| Karolinska University Hospital - Centre for Andrology and Sexual Medicine | |
| Stockholm, Sweden | |
| 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, United Kingdom | |
Sponsors and Collaborators
New England Research Institutes
Bayer
Investigators
| Principal Investigator: | Raymond Rosen, PhD | New England Research Institutes, Inc |
More Information
No publications provided
| Responsible Party: | New England Research Institutes |
| ClinicalTrials.gov Identifier: | NCT00858650 History of Changes |
| Other Study ID Numbers: | RHyMe |
| Study First Received: | March 9, 2009 |
| Last Updated: | October 18, 2012 |
| Health Authority: | European Union: Ethics Committee |
Keywords provided by New England Research Institutes:
|
registry natural history |
Additional relevant MeSH terms:
|
Hypogonadism Eunuchism Gonadal Disorders Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013