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Registry of Hypogonadism in Men


N/A
18 Years
N/A
Open (Enrolling)
Male
Male Hypogonadism, Androgen Deficiency, Testosterone Deficiency

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Trial Information

Registry of Hypogonadism in Men


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Prostate Cancer

Outcome Time Frame:

2-years

Safety Issue:

Yes

Principal Investigator

Raymond Rosen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New England Research Institutes, Inc

Authority:

European Union: Ethics Committee

Study ID:

RHyMe

NCT ID:

NCT00858650

Start Date:

March 2009

Completion Date:

Related Keywords:

  • Male Hypogonadism
  • Androgen Deficiency
  • Testosterone Deficiency
  • registry
  • natural history
  • Hypogonadism
  • Eunuchism

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