Registry of Hypogonadism in Men (RHyMe)

August 22, 2016 updated by: HealthCore-NERI
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Halle (Saale), Germany
        • University Hospital Halle - Center for Reproductive Medicine and Andrology
      • Hamburg, Germany
        • Institute of Urology and Andrology, Segeberger Kliniken
      • Hamburg, Germany
        • Private Practice of Andrology & Urology
      • Herne, Germany
        • Klinik fur Innere Medizin,
  • Italy
      • Ancona, Italy
        • Ospedali Riuniti
      • Florence, Italy
        • Unità di Andrologia DFC AziendaOspedalieraUniversitariaCareggi
      • Modena, Italy
        • Hesperia Hospital
      • Parma, Italy
        • University of Parma
      • Rome, Italy
        • University of Rome - Sapienza
  • Netherlands
      • Amstelveen, Netherlands
        • Amstelland Hospital
      • Amsterdam, Netherlands
        • VU medical centre, department of Urology
      • Arnhem, Netherlands
        • Andros Men's Health Institutes
      • Rotterdam, Netherlands
        • Erasmus Medical Center - Urology
  • Spain
      • Barcelona, Spain
        • Fundacio Puigvert
      • Madrid, Spain
        • Hospital Universitario Doce de Octubre
      • Madrid, Spain
        • Hospital Universitario Puerta de Hierro- Majadahonda
      • Malaga, Spain
        • Hospital Carlos Haya
      • Sevilla, Spain
        • Hospital Virgen del Rocío
  • Sweden
      • Gotenborg, Sweden
        • Urohälsan i Skövde: Gotenborg University
      • Stockholm, Sweden
        • Karolinska University Hospital - Centre for Andrology and Sexual Medicine
  • United Kingdom
      • Barnsley, United Kingdom
        • Barnsley Hospital
      • Hampstead, United Kingdom
        • Royal Free Hospital
      • Lichfield, United Kingdom
        • Holly Cottage Clinic
      • Manchester, United Kingdom
        • Manchester Royal Infirmary
      • Newcastle, United Kingdom
        • Royal Victoria Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Hypogonadal men

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prostate Cancer
Time Frame: 2-years
2-years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthCore-NERI

Collaborators

Bayer
Besins Healthcare

Investigators

  • Principal Investigator: Raymond Rosen, PhD, New England Research Institutes, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

March 9, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (ESTIMATE)

March 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHyMe

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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