HealthyPhase 1/2NCT00740194
Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men
A Phase 1/2 study testing Aromatase inhibition and Estradiol in people with Healthy, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Aromatase inhibition versus estradiol during 1 week Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aromatase inhibition and Estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2008to Aug 2010
- Phase
- Phase 1/2
- 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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent obtained.
- Male subjects
- Age 18 - 40
- weight < 120 kg
Who cannot join
- Primary hypogonadism or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
- Treatment with insulin, corticoids, opiates (on a daily basis), androgen- or estrogen analogs or CYP2A6 substrates (Dexmedetomidine, Ifosfamide, Methoxsalen, Miconazole, Tranylcypromine).
- Impaired renal function defined as serum-creatine > 1.5 mg/dL
- Impaired liver function, defined as ALAT > 2.5 times upper limit of normal
- Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III or IV) at the discretion of the investigator
- Cancer or any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial
Show all 9Show fewer
- Palpable prostate nodule or induration, PSA > 3 ng/mL, prostatism, untreated sleep apnee syndrome, erythrocytosis (hematocrit > 50%) or hyperviscosity.
- Known or suspected abuse of alcohol or narcotics
- Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men.
Aromatase inhibition versus estradiol during 1 week
- Conditions
- Healthy
- Being tested
- Aromatase inhibition, Estradiol
- Keywords
- Physiology, males
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatase inhibitionDrug
Letrozole
EstradiolDrug
Dermestril
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Aromatase inhibition Receives: Drug: Aromatase inhibition |
| 2 | Active comparator | Estradiol Receives: Drug: Estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of sex steroids on adipocytes
Measured: 1 week
Secondary outcomes (1)
Effects of sex steroids on lipid metabolism
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Ruige, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740194
- Sponsor's protocol ID
- 2007/279
- Status last verified
- Aug 2011
- First submitted
- 21 Aug 2008
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men.
- ClinicalTrials.gov ID
- NCT00740194
- Acronym / sponsor ID
- 2007/279
- Conditions
- Healthy
- Keywords
- Physiology, males
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Aug 2008 (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.
Aromatase inhibition versus estradiol during 1 week
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Aromatase inhibitionAromatase inhibition |
| 2 | Active comparator | Drug: EstradiolEstradiol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Informed consent obtained.
- Male subjects
- Age 18 - 40
- weight < 120 kg
Key exclusion criteria (9 listed)
- Primary hypogonadism or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
- Treatment with insulin, corticoids, opiates (on a daily basis), androgen- or estrogen analogs or CYP2A6 substrates (Dexmedetomidine, Ifosfamide, Methoxsalen, Miconazole, Tranylcypromine).
- Impaired renal function defined as serum-creatine > 1.5 mg/dL
- Impaired liver function, defined as ALAT > 2.5 times upper limit of normal
- Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III or IV) at the discretion of the 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 |
|---|---|---|
| Aromatase inhibitionLetrozole | Drug | 1 |
| EstradiolDermestril | Drug | 2 |
Primary outcome
Effects of sex steroids on adipocytes
Time frame: 1 week
1 secondary outcome
Effects of sex steroids on lipid metabolism
Time frame: 1 week
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 30 Aug 2011.
- Website of the University Hospital GhentLink provided by the sponsor.
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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.
Johannes Ruige, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aromatase inhibition and Estradiol in people with Healthy, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 9 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 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effects of sex steroids on adipocytes (time frame: 1 week). 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 30 Aug 2011.