Hypogonadotrophic HypogonadismPhase 3NCT00138710
Short-term Effects of Aromatase Inhibition in Obese Men
A Phase 3 study testing Letrozole (Femara) in people with Hypogonadotrophic Hypogonadism and Obesity, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
In this study, 50 obese men with a hormonal imbalance will be treated with letrozole or placebo for six months in order to examine the effects on the hormonal balance, and on weight loss. The study will also address the side effects and psychological effects of letrozole as compared to placebo. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Hypogonadotrophic Hypogonadism, Obesity
- What is being tested?
- Letrozole (Femara)
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2005to Jan 2010
- Phase
- Phase 3
- 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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- BMI between 35 and 50
- Male sex
- Ages between 20 and 50
- Serum total testosterone under 10 nmol/l
- Serum luteinizing hormone (LH) under 9 mU/l
- Serum estradiol over 40 pmol/l
Who cannot join
- Comorbidity
- Serum prostate-specific antigen (PSA) over 4.0 U/l
- Discontinuation of smoking less than six months ago
- Medication known to affect hormonal parameters
Trial locations and contacts
1 site in 1 country.
About this study
In this study, 50 obese men with a hormonal imbalance will be treated with letrozole or placebo for six months in order to examine the effects on the hormonal balance, and on weight loss. The study will also address the side effects and psychological effects of letrozole as compared to placebo.
Read the detailed description
The aim of the study is to establish the short-term efficacy and safety of aromatase inhibition in restoring and maintaining eugonadism in hypogonadotrophic hypogonadal men. Secondary aim is to detect the short-term somatic and psychological effects.
Study design: Double blind randomized placebo-controlled trial.
Treatment: 26 weeks of either letrozole or placebo. All patients will start on 1 tablet per week, dose adjustments will be performed if serum testosterone or estradiol are outside the target range. All men will be prescribed a mildly hypocaloric diet.
Endpoints: BMI, body weight, waist circumference, body composition, exercise capacity, serum levels of several hormone markers, glucose tolerance, psychological characteristics.
All patients will be measured 6 times during the study.
- Conditions
- Hypogonadotrophic Hypogonadism, Obesity
- Being tested
- Letrozole (Femara)
- Keywords
- obesity, Hypogonadotrophic hypogonadism, aromatase inhibition
- Medical subject headings
- Hypogonadism, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole (Femara)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body mass index (BMI)
Waist circumference
Body composition
Exercise capacity
Serum levels of hormones
Glucose tolerance
Reported side effects
Psychological characteristics (Symptom Checklist, intelligence quotient [IQ] NPV)
Secondary outcomes (4)
Lipid profile
Blood counts
Bone markers
Liver enzymes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadotrophic 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hans de Boer, MD PhD, Principal investigator, Rijnstate Hospital, Arnhem, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138710
- Sponsor's protocol ID
- LTC-323-150405
- Status last verified
- Oct 2010
- First submitted
- 29 Aug 2005
- Last updated
- 22 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Aromatase Inhibition in Obese Men
- ClinicalTrials.gov ID
- NCT00138710
- Acronym / sponsor ID
- LTC-323-150405
- Conditions
- Hypogonadotrophic Hypogonadism, Obesity
- Keywords
- obesity, Hypogonadotrophic hypogonadism, aromatase inhibition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 30 Aug 2005 (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.
In this study, 50 obese men with a hormonal imbalance will be treated with letrozole or placebo for six months in order to examine the effects on the hormonal balance, and on weight loss. The study will also address the side effects and psychological effects of letrozole as compared to placebo.
Detailed description
The aim of the study is to establish the short-term efficacy and safety of aromatase inhibition in restoring and maintaining eugonadism in hypogonadotrophic hypogonadal men. Secondary aim is to detect the short-term somatic and psychological effects.
Study design: Double blind randomized placebo-controlled trial.
Treatment: 26 weeks of either letrozole or placebo. All patients will start on 1 tablet per week, dose adjustments will be performed if serum testosterone or estradiol are outside the target range. All men will be prescribed a mildly hypocaloric diet.
Endpoints: BMI, body weight, waist circumference, body composition, exercise capacity, serum levels of several hormone markers, glucose tolerance, psychological characteristics.
All patients will be measured 6 times during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMI between 35 and 50
- Male sex
- Ages between 20 and 50
- Serum total testosterone under 10 nmol/l
- Serum luteinizing hormone (LH) under 9 mU/l
Key exclusion criteria (4 listed)
- Comorbidity
- Serum prostate-specific antigen (PSA) over 4.0 U/l
- Discontinuation of smoking less than six months ago
- Medication known to affect hormonal parameters
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 |
|---|---|---|
| Letrozole (Femara) | Drug | – |
Primary outcome
Body weight
Body mass index (BMI)
Waist circumference
Body composition
Exercise capacity
Serum levels of hormones
Glucose tolerance
Reported side effects
Psychological characteristics (Symptom Checklist, intelligence quotient [IQ] NPV)
4 secondary outcomes
Lipid profile
Blood counts
Bone markers
Liver enzymes
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 22 Oct 2010.
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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.
Hans de Boer, MD PhD principal investigator
Rijnstate Hospital, Arnhem, the Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letrozole (Femara) in people with Hypogonadotrophic Hypogonadism and Obesity, run by Rijnstate Hospital at 1 site in Netherlands.
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 6 inclusion and 4 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 22 Oct 2010. 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 Netherlands. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Body weight. The study lists 9 primary outcomes in all. 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 22 Oct 2010.