HypogonadismPhase 4NCT02433730
Testosterone Therapy in Hypogonadal Men Treated With Opioids
A Phase 4 study testing Testosterone in people with Hypogonadism, run by Marianne Andersen at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the efficacy of testosterone replacement therapy in men with low testosterone due to opioid treatment on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Testosterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2015to 1 Sep 2019
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients 18-75 years
- Treatment with opioid for >3 months, daily dose >50-100 mg
- Total testosterone < 12 mmol/L
- Follicle Stimulating Hormone (FSH)/Luteinizing Hormone (LH) levels normal og below normal laboratory values
- Normal prolactin levels
Who cannot join
- Hematocrit> 54% at screening
- Prostate Specific Antigen (PSA) > 3 ng/ml
- Severe organic and mental disease
- current or present cancer diagnosis
- Previous venous thrombotic embolism and cerebrovascular disease
- Uncontrolled hypertension
Show all 14Show fewer
- Epilepsy or migraine not adequately controlled by therapy
- Severe benign prostate hypertrophy with symptom score >19
- Sleep apnea
- Alcohol or drug abuse
- Implantation of sustained action sex hormone in the last 12 months
- Use of oral, buccal or transdermal testosterone in the last two weeks
- Treatment with glucocorticoids > 5 mg/day or 5 alfa reductase inhibitors
- Hypersensitivity to Nebido
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Testosterone Replacement in Patients With Hypogonadotrophic Hypogonadism Due to Opioid Treatment for Non-malignant Disease
The purpose of this study is to evaluate the efficacy of testosterone replacement therapy in men with low testosterone due to opioid treatment on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life.
Male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40 patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20 patients per arm
A double blinded randomized placebo controlled trial
Read the detailed description
The study duration is 24 weeks. Patients are treated with Testosterone Undecanoate 1000 mg/4 ml, intramuscular (i.m.) or placebo at 0, 6 and 18 weeks.
Outcome measures will be evaluated at 0 and 14 weeks.
- Conditions
- Hypogonadism
- Being tested
- Testosterone, placebo
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Also called nebido
intramuscular injection
placeboDrug
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| placebo | Active comparator | intramuscular injection Receives: Drug: placebo |
| testosterone | Active comparator | intramuscular injection Receives: Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
lean body mass
dual xray absorptiometry scan
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study start1 May 2015
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marianne Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marianne Andersen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433730
- Sponsor's protocol ID
- 22102014
- Status last verified
- Sep 2020
- First submitted
- 27 Jan 2015
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Olesen TB, Glintborg D, Johnk F, Olsen MH, Andersen MS. Blood pressure responses to testosterone therapy are amplified by hematocrit levels in opioid-induced androgen deficiency: a double-blind, randomized, placebo-controlled trial. J Hypertens. 2024 May 1;42(5):893-901. doi: 10.1097/HJH.0000000000003638. Epub 2023 Dec 13.
PubMed 38088425
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Testosterone Replacement in Patients With Hypogonadotrophic Hypogonadism Due to Opioid Treatment for Non-malignant Disease
- ClinicalTrials.gov ID
- NCT02433730
- Acronym / sponsor ID
- 22102014
- Conditions
- Hypogonadism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marianne AndersenUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 5 May 2015 (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 purpose of this study is to evaluate the efficacy of testosterone replacement therapy in men with low testosterone due to opioid treatment on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life.
Male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40 patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20 patients per arm
A double blinded randomized placebo controlled trial
Detailed description
The study duration is 24 weeks. Patients are treated with Testosterone Undecanoate 1000 mg/4 ml, intramuscular (i.m.) or placebo at 0, 6 and 18 weeks.
Outcome measures will be evaluated at 0 and 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Active comparator | Drug: placebointramuscular injection |
| testosterone | Active comparator | Drug: Testosteroneintramuscular injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients 18-75 years
- Treatment with opioid for >3 months, daily dose >50-100 mg
- Total testosterone < 12 mmol/L
- Follicle Stimulating Hormone (FSH)/Luteinizing Hormone (LH) levels normal og below normal laboratory values
- Normal prolactin levels
Key exclusion criteria (14 listed)
- Hematocrit> 54% at screening
- Prostate Specific Antigen (PSA) > 3 ng/ml
- Severe organic and mental disease
- current or present cancer diagnosis
- Previous venous thrombotic embolism and cerebrovascular disease
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: nebidointramuscular injection | Drug | testosterone |
| placebointramuscular injection | Drug | placebo |
Primary outcome
lean body mass
Time frame: 24 weeks
dual xray absorptiometry scan
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 16 Sep 2020.
- Derived from this study: PubMed 38088425Olesen TB, Glintborg D, Johnk F, Olsen MH, Andersen MS. Blood pressure responses to testosterone therapy are amplified by hematocrit levels in opioid-induced androgen deficiency: a double-blind, randomized, placebo-controlled trial. J Hypertens. 2024 May 1;42(5):893-901. doi: 10.1097/HJH.0000000000003638. Epub 2023 Dec 13.
Related trials for Hypogonadism
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism
Male Hypogonadism
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
RecruitingPhase 2
Clinical Trial to Observe the Effects of Tamoxifen on Testosterone Recovery in Medically Castrated Prostate Cancer Patients
Hypogonadism, Prostate Cancer
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 4 study testing Testosterone in people with Hypogonadism, run by Marianne Andersen 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 5 inclusion and 14 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 16 Sep 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. 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?
lean body mass (time frame: 24 weeks). 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 NCT02433730, which also lists 1 linked publication.
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 16 Sep 2020; AzTrials last refreshed its copy on 31 Oct 2026.