Male HypogonadismRHyMeNCT00858650
Registry of Hypogonadism in Men
An observational study of Male Hypogonadism and Androgen Deficiency, run by Carelon Research at 25 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Male Hypogonadism, Androgen Deficiency, Testosterone Deficiency
- How many people
- 999 participants
- Where
- 25 sitesin 6 countries
- Study dates
- Mar 2009to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Hypogonadal men
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
Italy5 sites
Ospedali Riuniti
Ancona
Unità di Andrologia DFC AziendaOspedalieraUniversitariaCareggi
Florence
Hesperia Hospital
Modena
University of Parma
Parma
University of Rome - Sapienza
Rome
Spain5 sites
Fundacio Puigvert
Barcelona
Hospital Universitario doce de Octubre
Madrid
Hospital Universitario Puerta de Hierro- Majadahonda
Madrid
Hospital Carlos Haya
Málaga
Hospital Virgen del Rocio
Seville
United Kingdom5 sites
Barnsley Hospital
Barnsley
Royal Free Hospital
Hampstead
Holly Cottage Clinic
Lichfield
Manchester Royal Infirmary
Manchester
Royal Victoria Infirmary
Newcastle
Germany4 sites
University Hospital Halle - Center for Reproductive Medicine and Andrology
Halle
Institute of Urology and Andrology, Segeberger Kliniken
Hamburg
Private Practice of Andrology & Urology
Hamburg
Klinik fur Innere Medizin,
Herne
Netherlands4 sites
Amstelland Hospital
Amstelveen
VU medical centre, department of Urology
Amsterdam
Andros Men's Health Institutes
Arnhem
Erasmus Medical Center - Urology
Rotterdam
Sweden2 sites
Urohälsan i Skövde: Gotenborg University
Gotenborg
Karolinska University Hospital - Centre for Andrology and Sexual Medicine
Stockholm
About this study
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.
- Being tested
- Standard of Care
- Keywords
- registry, natural history
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Standard of care may or may not include use of testosterone replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Hypogonadal males treated by standard of care, with or without testosterone replacement therapy Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Cancer
Measured: 2-years
Secondary outcomes (3)
PSA, IPSS, and Other Urologic Outcomes
Measured: 3-years
Sexual Function and Hypogonadism Symptoms
Measured: 3-years
Physical Health and Cardiovascular Outcome Measures
Measured: 3-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Besins Healthcare
- Responsible party
- Sponsor
- Investigators
- Raymond Rosen, PhD, Principal investigator, New England Research Institutes, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858650
- Sponsor's protocol ID
- RHyMe
- Acronym
- RHyMe
- Status last verified
- Apr 2016
- First submitted
- 9 Mar 2009
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Hypogonadism in Men
- ClinicalTrials.gov ID
- NCT00858650
- Acronym / sponsor ID
- RHyMe / RHyMe
- Keywords
- registry, natural history
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 999 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- Bayer, Besins Healthcare
- Study start
- Mar 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | – | Other: Standard of CareHypogonadal males treated by standard of care, with or without testosterone replacement therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypogonadal men
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareStandard of care may or may not include use of testosterone replacement therapy | Other | Standard of Care |
Primary outcome
Prostate Cancer
Time frame: 2-years
3 secondary outcomes
PSA, IPSS, and Other Urologic Outcomes
Time frame: 3-years
Sexual Function and Hypogonadism Symptoms
Time frame: 3-years
Physical Health and Cardiovascular Outcome Measures
Time frame: 3-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Rosen, PhD principal investigator
New England Research Institutes, Inc
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Hypogonadism and Androgen Deficiency, run by Carelon Research at 25 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Italy, Spain, United Kingdom, Germany, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate Cancer (time frame: 2-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.