Status:
COMPLETED
Registry of Hypogonadism in Men
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
Bayer
Besins Healthcare
Conditions:
Male Hypogonadism
Androgen Deficiency
Eligibility:
MALE
18+ years
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 hypogo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
999 Patients enrolled
Trial Details
Trial ID
NCT00858650
Start Date
March 1 2009
End Date
September 1 2013
Last Update
August 24 2016
Active Locations (25)
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1
University Hospital Halle - Center for Reproductive Medicine and Andrology
Halle, Germany
2
Institute of Urology and Andrology, Segeberger Kliniken
Hamburg, Germany
3
Private Practice of Andrology & Urology
Hamburg, Germany
4
Klinik fur Innere Medizin,
Herne, Germany