NCT00858650

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
999

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
6 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

August 24, 2016

Status Verified

April 1, 2016

Enrollment Period

4.5 years

First QC Date

March 9, 2009

Last Update Submit

August 22, 2016

Conditions

Male HypogonadismAndrogen DeficiencyTestosterone Deficiency

Keywords

registrynatural history

Outcome Measures

Primary Outcomes (1)

  • Prostate Cancer

    2-years

Secondary Outcomes (3)

  • PSA, IPSS, and Other Urologic Outcomes

    3-years

  • Sexual Function and Hypogonadism Symptoms

    3-years

  • Physical Health and Cardiovascular Outcome Measures

    3-years

Study Arms (1)

Standard of Care

Hypogonadal males treated by standard of care, with or without testosterone replacement therapy

Other: Standard of Care

Interventions

Standard of CareOTHER

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

Standard of Care

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hypogonadal men

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

University Hospital Halle - Center for Reproductive Medicine and Andrology

Halle, Germany

Location

Institute of Urology and Andrology, Segeberger Kliniken

Hamburg, Germany

Location

Private Practice of Andrology & Urology

Hamburg, Germany

Location

Klinik fur Innere Medizin,

Herne, Germany

Location

Ospedali Riuniti

Ancona, Italy

Location

Unità di Andrologia DFC AziendaOspedalieraUniversitariaCareggi

Florence, Italy

Location

Hesperia Hospital

Modena, Italy

Location

University of Parma

Parma, Italy

Location

University of Rome - Sapienza

Rome, Italy

Location

Amstelland Hospital

Amstelveen, Netherlands

Location

VU medical centre, department of Urology

Amsterdam, Netherlands

Location

Andros Men's Health Institutes

Arnhem, Netherlands

Location

Erasmus Medical Center - Urology

Rotterdam, Netherlands

Location

Fundacio Puigvert

Barcelona, Spain

Location

Hospital Universitario doce de Octubre

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro- Majadahonda

Madrid, Spain

Location

Hospital Carlos Haya

Málaga, Spain

Location

Hospital Virgen del Rocio

Seville, Spain

Location

Urohälsan i Skövde: Gotenborg University

Gotenborg, Sweden

Location

Karolinska University Hospital - Centre for Andrology and Sexual Medicine

Stockholm, Sweden

Location

Barnsley Hospital

Barnsley, United Kingdom

Location

Royal Free Hospital

Hampstead, United Kingdom

Location

Holly Cottage Clinic

Lichfield, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

Royal Victoria Infirmary

Newcastle, United Kingdom

Location

MeSH Terms

Conditions

Eunuchism

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HypogonadismGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Raymond Rosen, PhD

    New England Research Institutes, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2009

First Posted

March 10, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

August 24, 2016

Record last verified: 2016-04

Locations

SE(2)NL(4)ES(5)IT(5)GB(5)DE(4)