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Registry of Hypogonadism in Men (RHyMe)

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ClinicalTrials.gov Identifier: NCT00858650
Recruitment Status : Completed
First Posted : March 10, 2009
Last Update Posted : August 24, 2016
Sponsor:
Collaborators:
Bayer
Besins Healthcare
Information provided by (Responsible Party):
HealthCore-NERI

Study Description
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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.

Condition or disease Intervention/treatment
Male Hypogonadism Androgen Deficiency Testosterone Deficiency Other: Standard of Care

Study Design
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Study Type : Observational
Actual Enrollment : 999 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry of Hypogonadism in Men
Study Start Date : March 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013
Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Prostate Cancer [ Time Frame: 2-years ]

Secondary Outcome Measures :
  1. PSA, IPSS, and Other Urologic Outcomes [ Time Frame: 3-years ]
  2. Sexual Function and Hypogonadism Symptoms [ Time Frame: 3-years ]
  3. Physical Health and Cardiovascular Outcome Measures [ Time Frame: 3-years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hypogonadal men
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858650


Locations
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Sponsors and Collaborators
HealthCore-NERI
Bayer
Besins Healthcare
Investigators
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Principal Investigator: Raymond Rosen, PhD New England Research Institutes, Inc
More Information
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Responsible Party: HealthCore-NERI
ClinicalTrials.gov Identifier: NCT00858650    
Other Study ID Numbers: RHyMe
First Posted: March 10, 2009    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: April 2016
Keywords provided by HealthCore-NERI:
registry
natural history
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases