HypogonadismPhase 4NCT03619330
Testosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism.
A Phase 4 study testing liraglutide and Testosterone in people with Hypogonadism and Obesity, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study was to compare the effects of liraglutide and testosterone replacement therapy on features of hypogonadism and weight loss in obese men with persistent features of hypogonadism after unsuccessful lifestyle measures. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hypogonadism, Obesity
- What is being tested?
- liraglutide and Testosterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- Dec 2014to Aug 2015
- Phase
- Phase 4
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Liraglutide and Testosterone Replacement Therapy on Features of Hypogonadism and Weight Loss in Obese Men With Persistent Features of Hypogonadism.
The purpose of this study was to compare the effects of liraglutide and testosterone replacement therapy on features of hypogonadism and weight loss in obese men with persistent features of hypogonadism after unsuccessful lifestyle measures.
- Conditions
- Hypogonadism, Obesity
- Being tested
- liraglutide, Testosterone
- Medical subject headings
- Hypogonadism, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Also called Victoza 6 mg/ml solution for injection in pre-filled pen
In the liraglutide group liraglutide was initiated at a dose of 1.2 mg injected sc once per day and increased to 3 mg/day after 1 week.
TestosteroneDrug
Also called Androtop gel
In the testosterone group Androtop gel 5 grams (50 mg of testosterone) was applied once a day on a dry skin.
| Study group | Role | What they receive |
|---|---|---|
| liraglutide | Active comparator | In the LIRA group liraglutide was initiated at a dose of 1.2 mg injected sc once per day and increased to 3 mg/day after 1 week. Receives: Drug: liraglutide |
| testosterone | Active comparator | In the ANDRO group testosterone was initiated at a dose of 50 mg in a gel form once daily. Receives: Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome was improvements of symptoms related to hypogonadism
Measured: Patients were screened and asked for symptoms at the beginning and every 4 weeks for 16 weeks of the study.
The main outcome was change testosterone level.
Patient's blood was drawn between 8 and 9 a.m. Concentrations of testosterone was measured in nmol/L.
Measured: Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.
the main outcome was change in gonadotropin levels.
Measured: Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.
Secondary outcomes (2)
The secondary outcome was change in body weight.
Measured: Patient's body weight in kilograms were measured at the base point and every four weeks during the 16 weeks of clinical trial.
The secondary outcome was change in waist circumference.
Patient's waist circumference was measured in centimeters.
Measured: Patient's waist circumference was measured at the basepoint and every four weeks during 16 weeks of clinical trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study startDec 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrej Janez, University Medical Centre Ljubljana
- Investigators
- Andrej Janez, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619330
- Sponsor's protocol ID
- TESTOSTERON
- Status last verified
- Aug 2018
- First submitted
- 16 Jul 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Liraglutide and Testosterone Replacement Therapy on Features of Hypogonadism and Weight Loss in Obese Men With Persistent Features of Hypogonadism.
- ClinicalTrials.gov ID
- NCT03619330
- Acronym / sponsor ID
- TESTOSTERON
- Conditions
- Hypogonadism, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 Aug 2018 (actual)
- 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 purpose of this study was to compare the effects of liraglutide and testosterone replacement therapy on features of hypogonadism and weight loss in obese men with persistent features of hypogonadism after unsuccessful lifestyle measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liraglutide | Active comparator | Drug: liraglutideIn the LIRA group liraglutide was initiated at a dose of 1.2 mg injected sc once per day and increased to 3 mg/day after 1 week. |
| testosterone | Active comparator | Drug: TestosteroneIn the ANDRO group testosterone was initiated at a dose of 50 mg in a gel form once daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| liraglutideAlso: Victoza 6 mg/ml solution for injection in pre-filled penIn the liraglutide group liraglutide was initiated at a dose of 1.2 mg injected sc once per day and increased to 3 mg/day after 1 week. | Drug | liraglutide |
| TestosteroneAlso: Androtop gelIn the testosterone group Androtop gel 5 grams (50 mg of testosterone) was applied once a day on a dry skin. | Drug | testosterone |
Primary outcome
The main outcome was improvements of symptoms related to hypogonadism
Time frame: Patients were screened and asked for symptoms at the beginning and every 4 weeks for 16 weeks of the study.
The main outcome was change testosterone level.
Time frame: Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Concentrations of testosterone was measured in nmol/L.
the main outcome was change in gonadotropin levels.
Time frame: Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.
2 secondary outcomes
The secondary outcome was change in body weight.
Time frame: Patient's body weight in kilograms were measured at the base point and every four weeks during the 16 weeks of clinical trial.
The secondary outcome was change in waist circumference.
Time frame: Patient's waist circumference was measured at the basepoint and every four weeks during 16 weeks of clinical trial.
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 7 Aug 2018.
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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.
Andrej Janez, MD, PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing liraglutide and Testosterone in people with Hypogonadism and Obesity, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Aug 2018. 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 Slovenia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The main outcome was improvements of symptoms related to hypogonadism (time frame: Patients were screened and asked for symptoms at the beginning and every 4 weeks for 16 weeks of the study.). The study lists 3 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 7 Aug 2018.