RHyMe: Registry of Hypogonadism in Men

Sponsor

HealthCore-NERI (Other)

Overall Status

Completed

CT.gov ID

NCT00858650

Collaborator

Bayer (Industry), Besins Healthcare (Industry)

999

Enrollment

Locations

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Male Hypogonadism Androgen Deficiency Testosterone Deficiency	Other: Standard of Care

Study Design

Study Type:

Observational

Actual Enrollment :

999 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Registry of Hypogonadism in Men

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

Prostate Cancer [2-years]

Secondary Outcome Measures

PSA, IPSS, and Other Urologic Outcomes [3-years]
Sexual Function and Hypogonadism Symptoms [3-years]
Physical Health and Cardiovascular Outcome Measures [3-years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	University Hospital Halle - Center for Reproductive Medicine and Andrology	Halle (Saale)	Germany
2	Institute of Urology and Andrology, Segeberger Kliniken	Hamburg	Germany
3	Private Practice of Andrology & Urology	Hamburg	Germany
4	Klinik fur Innere Medizin,	Herne	Germany
5	Ospedali Riuniti	Ancona	Italy
6	Unità di Andrologia DFC AziendaOspedalieraUniversitariaCareggi	Florence	Italy
7	Hesperia Hospital	Modena	Italy
8	University of Parma	Parma	Italy
9	University of Rome - Sapienza	Rome	Italy
10	Amstelland Hospital	Amstelveen	Netherlands
11	VU medical centre, department of Urology	Amsterdam	Netherlands
12	Andros Men's Health Institutes	Arnhem	Netherlands
13	Erasmus Medical Center - Urology	Rotterdam	Netherlands
14	Fundacio Puigvert	Barcelona	Spain
15	Hospital Universitario doce de Octubre	Madrid	Spain
16	Hospital Universitario Puerta de Hierro- Majadahonda	Madrid	Spain
17	Hospital Carlos Haya	Malaga	Spain
18	Hospital Virgen del Rocio	Sevilla	Spain
19	Urohälsan i Skövde: Gotenborg University	Gotenborg	Sweden
20	Karolinska University Hospital - Centre for Andrology and Sexual Medicine	Stockholm	Sweden
21	Barnsley Hospital	Barnsley	United Kingdom
22	Royal Free Hospital	Hampstead	United Kingdom
23	Holly Cottage Clinic	Lichfield	United Kingdom
24	Manchester Royal Infirmary	Manchester	United Kingdom
25	Royal Victoria Infirmary	Newcastle	United Kingdom

Sponsors and Collaborators

HealthCore-NERI
Bayer
Besins Healthcare

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

HealthCore-NERI

ClinicalTrials.gov Identifier:

NCT00858650

Other Study ID Numbers:

RHyMe

First Posted:

Mar 10, 2009

Last Update Posted:

Aug 24, 2016

Last Verified:

Apr 1, 2016

Keywords provided by HealthCore-NERI

registry

natural history

Additional relevant MeSH terms:

Hypogonadism

Study Results

No Results Posted as of Aug 24, 2016