Metabolic SyndromePhase 2/3EinsteinNCT02991209
Study of Testosterone vs Placebo in Testicular Cancer Survivors
A Phase 2/3 study testing Testosterone in people with Metabolic Syndrome and Testicular Cancer, run by Mikkel Bandak at 1 site in Denmark.
Trial summary
The overall purpose of the study is to evaluate the effect of 12 months testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in order to reduce the risk of cardiovascular disease. The primary study objective is to evaluate changes in insulin sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Metabolic Syndrome, Testicular Cancer, Leydig Cell Failure in Adult
- What is being tested?
- Testosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to Jun 2019
- Phase
- Phase 2/3
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Previous treatment for testicular cancer.
- No signs of relapse 1 year after last treatment (orchiectomy, radiotherapy, chemotherapy).
- Free testosterone < the age-adjusted median and > -2 standard deviations (SD) from the age-adjusted median and LH > 2 SD from the age-adjusted median.
Who cannot join
- Treatment with testosterone within the last 6 months.
- Contraindications to testosterone treatment (prostate cancer, prostate specific antigen (PSA)> 4 ng/mL), malignancy suspect prostate by digital rectal examination, Alanine aminotransferase (ALT)> 1.5 upper reference level, Erythrocyte Volume Fraction (EVF) > 50%.
- Breast cancer.
- Symptomatic obstructive sleep apnoea syndrome
- Heart failure > NYHA II.
- Uncontrolled hypertension: (Systolic blood pressure > 160 mm Hg despite antihypertensive treatment, measured at two separate occasions)
Show all 10Show fewer
- Inability to understand information about the trial
- Participation in any other clinical trial
- Allergy for the active substance or additives in Tostran or placebo.
- Known diabetes mellitus, or diabetes mellitus detected at screening or baseline tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-blind Study of Testosterone Replacement Therapy or Placebo in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency (Einstein-intervention)
The overall purpose of the study is to evaluate the effect of 12 months testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in order to reduce the risk of cardiovascular disease.
The primary study objective is to evaluate changes in insulin sensitivity. The secondary study objective is to evaluate changes in the prevalence of metabolic syndrome, body composition, systemic inflammation and symptoms of testosterone deficiency.
Read the detailed description
This is a single-center, randomized, double-blind, placebo-controlled intervention study, designed to evaluate the effect of testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency.
70 subjects will be randomized to receive either testosterone replacement therapy or placebo. The subjects will be invited for an information meeting where informed consent is signed. If a subject is suitable for participation in the trial, subject will be randomized to testosterone replacement therapy or placebo and baseline investigations will be performed. Afterwards, a 52-weeks treatment period begins in which subjects receive a daily dose of testosterone or placebo. Dose adjustment will be made three times during the first 8 weeks of the study. Evaluation of primary and secondary endpoints will be performed after 26 weeks, at the end of treatment (52 weeks) and three months after completion of treatment (week 64).
- Being tested
- Testosterone, Placebos
- Medical subject headings
- Metabolic Syndrome, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Also called Tostran
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| Tostran 2% | Experimental | 1 years treatment with transdermal Tostran 2% Receives: Drug: Testosterone |
| Placebo | Placebo comparator | 1 years treatment with placebo gel Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in insulin sensitivity
Evaluation of changes in two hours plasma glucose investigated by Oral Glucose Tolerance Test (OGTT)
Measured: 1 year
Secondary outcomes (13)
Changes in fasting plasma lipids between baseline and 52 weeks
Measured: 1 year
Changes in BMD and fat percent between baseline 52 weeks
BMD and body composition evaluated by DXA-scan
Measured: 1 year
Changes in systemic inflammation between baseline and 52 weeks
Analysis of tnf-alfa, interleukine 1-beta, interleukine 1, interleukine 6, interleukine 8
Measured: 1 year
Changes in plasma-adipocytokines between baseline and 52 weeks
Measured: 1 year
Changes in fasting plasma glucose between baseline and 52 weeks
Measured: 1 year
Changes in Quality of life between baseline and 52 weeks.
EORTC-QLQ C30
Measured: 1 year
Adverse events evaluated by the Common Terminology Criteria for Adverse Events Version 4.0
Measured: 1 year
Changes in prevalence of metabolic syndrome between baseline and 52 weeks
According to NCEP-ATPIII criteria
Measured: 1 year
Changes in haemoglobin A1c between baseline and 52 weeks
Measured: 1 year
Changes in plasma insulin between baseline and 52 weeks
Measured: 1 year
Changes in fatigue between baseline and 52 weeks
MFI-20 (Multidimensional Fatigue Inventory)
Measured: 1 year
Changes in Anxiety and depression between baseline and 52 weeks
HADS (Hospital Anxiety and Depression Scale)
Measured: 1 year
Changes in Symptoms of low levels of testosterone, erectile dysfunction between baseline and 52 weeks
IIEF-15 (International Index of Erectile Dysfunction)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mikkel Bandak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mikkel Bandak, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991209
- Sponsor's protocol ID
- 010815Testis
- Acronym
- Einstein
- Status last verified
- Mar 2020
- First submitted
- 25 Nov 2016
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kreiberg M, Jorgensen N, Juul A, Lauritsen J, Oturai P, Helge JW, Christensen JF, Aksglaede L, Schauer T, Wagner T, Rosenvilde J, Grunwald E, Dehlendorff C, Daugaard G, Bandak M. A randomized double-blind single center study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention). Clin Genitourin Cancer. 2022 Oct;20(5):404-414. doi: 10.1016/j.clgc.2022.04.017. Epub 2022 May 2.
PubMed 35701334Hojer EG, Kreiberg M, Dehlendorff C, Jorgensen N, Juul A, Lauritsen J, Wagner T, Rosenvilde J, Daugaard G, Bandak M. Effect of Testosterone Replacement Therapy on Quality of Life and Sexual Function in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency: Results From a Randomized Double-blind Trial. Clin Genitourin Cancer. 2022 Aug;20(4):334-343. doi: 10.1016/j.clgc.2022.03.012. Epub 2022 Apr 1.
PubMed 35514022Priskorn L, Kreiberg M, Bandak M, Lauritsen J, Daugaard G, Petersen JH, Aksglaede L, Juul A, Jorgensen N. Testicular cancer survivors have shorter anogenital distance that is not increased by 1 year of testosterone replacement therapy. Hum Reprod. 2021 Aug 18;36(9):2443-2451. doi: 10.1093/humrep/deab162.
PubMed 34223605Bandak M, Jorgensen N, Juul A, Lauritsen J, Kreiberg M, Oturai PS, Helge JW, Daugaard G. A randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention). BMC Cancer. 2017 Jul 3;17(1):461. doi: 10.1186/s12885-017-3456-5.
PubMed 28673265
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Study of Testosterone Replacement Therapy or Placebo in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency (Einstein-intervention)
- ClinicalTrials.gov ID
- NCT02991209
- Acronym / sponsor ID
- Einstein / 010815Testis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Mikkel BandakUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 13 Dec 2016 (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 overall purpose of the study is to evaluate the effect of 12 months testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in order to reduce the risk of cardiovascular disease.
The primary study objective is to evaluate changes in insulin sensitivity. The secondary study objective is to evaluate changes in the prevalence of metabolic syndrome, body composition, systemic inflammation and symptoms of testosterone deficiency.
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled intervention study, designed to evaluate the effect of testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency.
70 subjects will be randomized to receive either testosterone replacement therapy or placebo. The subjects will be invited for an information meeting where informed consent is signed. If a subject is suitable for participation in the trial, subject will be randomized to testosterone replacement therapy or placebo and baseline investigations will be performed. Afterwards, a 52-weeks treatment period begins in which subjects receive a daily dose of testosterone or placebo. Dose adjustment will be made three times during the first 8 weeks of the study. Evaluation of primary and secondary endpoints will be performed after 26 weeks, at the end of treatment (52 weeks) and three months after completion of treatment (week 64).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tostran 2% | Experimental | Drug: Testosterone1 years treatment with transdermal Tostran 2% |
| Placebo | Placebo comparator | Drug: Placebos1 years treatment with placebo gel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent.
- Previous treatment for testicular cancer.
- No signs of relapse 1 year after last treatment (orchiectomy, radiotherapy, chemotherapy).
- Free testosterone < the age-adjusted median and > -2 standard deviations (SD) from the age-adjusted median and LH > 2 SD from the age-adjusted median.
Key exclusion criteria (10 listed)
- Treatment with testosterone within the last 6 months.
- Contraindications to testosterone treatment (prostate cancer, prostate specific antigen (PSA)> 4 ng/mL), malignancy suspect prostate by digital rectal examination, Alanine aminotransferase (ALT)> 1.5 upper reference level, Erythrocyte Volume Fraction (EVF) > 50%.
- Breast cancer.
- Symptomatic obstructive sleep apnoea syndrome
- Heart failure > NYHA II.
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 |
|---|---|---|
| TestosteroneAlso: Tostran | Drug | Tostran 2% |
| Placebos | Drug | Placebo |
Primary outcome
Changes in insulin sensitivity
Time frame: 1 year
Evaluation of changes in two hours plasma glucose investigated by Oral Glucose Tolerance Test (OGTT)
13 secondary outcomes
Changes in fasting plasma lipids between baseline and 52 weeks
Time frame: 1 year
Changes in BMD and fat percent between baseline 52 weeks
Time frame: 1 year
Changes in systemic inflammation between baseline and 52 weeks
Time frame: 1 year
Changes in plasma-adipocytokines between baseline and 52 weeks
Time frame: 1 year
Changes in fasting plasma glucose between baseline and 52 weeks
Time frame: 1 year
Changes in Quality of life between baseline and 52 weeks.
Time frame: 1 year
Adverse events evaluated by the Common Terminology Criteria for Adverse Events Version 4.0
Time frame: 1 year
Changes in prevalence of metabolic syndrome between baseline and 52 weeks
Time frame: 1 year
Changes in haemoglobin A1c between baseline and 52 weeks
Time frame: 1 year
Changes in plasma insulin between baseline and 52 weeks
Time frame: 1 year
Changes in fatigue between baseline and 52 weeks
Time frame: 1 year
Changes in Anxiety and depression between baseline and 52 weeks
Time frame: 1 year
Changes in Symptoms of low levels of testosterone, erectile dysfunction between baseline and 52 weeks
Time frame: 1 year
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 6 Mar 2020.
- Derived from this study: PubMed 35701334Kreiberg M, Jorgensen N, Juul A, Lauritsen J, Oturai P, Helge JW, Christensen JF, Aksglaede L, Schauer T, Wagner T, Rosenvilde J, Grunwald E, Dehlendorff C, Daugaard G, Bandak M. A randomized double-blind single center study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention). Clin Genitourin Cancer. 2022 Oct;20(5):404-414. doi: 10.1016/j.clgc.2022.04.017. Epub 2022 May 2.
- Derived from this study: PubMed 35514022Hojer EG, Kreiberg M, Dehlendorff C, Jorgensen N, Juul A, Lauritsen J, Wagner T, Rosenvilde J, Daugaard G, Bandak M. Effect of Testosterone Replacement Therapy on Quality of Life and Sexual Function in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency: Results From a Randomized Double-blind Trial. Clin Genitourin Cancer. 2022 Aug;20(4):334-343. doi: 10.1016/j.clgc.2022.03.012. Epub 2022 Apr 1.
- Derived from this study: PubMed 34223605Priskorn L, Kreiberg M, Bandak M, Lauritsen J, Daugaard G, Petersen JH, Aksglaede L, Juul A, Jorgensen N. Testicular cancer survivors have shorter anogenital distance that is not increased by 1 year of testosterone replacement therapy. Hum Reprod. 2021 Aug 18;36(9):2443-2451. doi: 10.1093/humrep/deab162.
- Derived from this study: PubMed 28673265Bandak M, Jorgensen N, Juul A, Lauritsen J, Kreiberg M, Oturai PS, Helge JW, Daugaard G. A randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention). BMC Cancer. 2017 Jul 3;17(1):461. doi: 10.1186/s12885-017-3456-5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Testosterone in people with Metabolic Syndrome and Testicular Cancer, run by Mikkel Bandak at 1 site in Denmark.
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 10 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 6 Mar 2020. 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 Denmark. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in insulin sensitivity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02991209, which also lists 4 linked publications.
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 6 Mar 2020.