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OpenTrials
Completed

NCT Number: NCT00858650

Registry of Hypogonadism in Men

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University Hospital Halle - Center for Reproductive Medicine and Andrology, Halle, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard of care

Other

Standard of care may or may not include use of testosterone replacement therapy

Primary outcomes

  1. Prostate Cancer

    Time frame: 2-years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Carelon Research

Other

Collaborators

  • Bayer
  • Besins Healthcare

Registry information

Acronym: RHyMe

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 10, 2009
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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