Registry of Hypogonadism in Men

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00858650

Acronym

RHyMe

Enrollment

999

Registered

2009-03-10

Start date

2009-03-31

Completion date

2013-09-30

Last updated

2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgen Deficiency, Male Hypogonadism, Testosterone Deficiency

Keywords

registry, natural history

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.

Interventions

OTHERStandard of Care

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Prostate Cancer	2-years

Secondary

Measure	Time frame
PSA, IPSS, and Other Urologic Outcomes	3-years
Sexual Function and Hypogonadism Symptoms	3-years
Physical Health and Cardiovascular Outcome Measures	3-years

Countries

Germany, Italy, Netherlands, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026