Metabolic SyndromePhase 3NePlaM3NCT00696748
The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
A Phase 3 study testing Nebido (testosterone undecanoate) in people with Metabolic Syndrome and Hypogonadism, run by Russian Academy of Medical Sciences at 1 site in Russia.
Trial summary
The objective of the study is to assess the effect of the testosterone therapy on the body composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic syndrome and hypogonadism. Read more about this study
- Who is it for?
- Ages 35 to 70 years, men only
- Conditions the study is for
- Metabolic Syndrome, Hypogonadism
- What is being tested?
- Nebido (testosterone undecanoate)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2005to Dec 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 35 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A signed informed consent to participate in the study
- Men aged 35 to 70 with testosterone levels below 12 nmol/L or free testosterone below 225 pmol/L
- Presence of the metabolic syndrome according to the IDF definition
Who cannot join
- Patients under 35 or above 70 years.
- Participation in any clinical study within 30 days before the first injection of the drug
- Simultaneous participation in another clinical study
- Incapable subjects as well as prisoners
- Suspicion of a serious organic or mental disease according to medical history and/or clinical examination
- Prostate cancer, breast cancer or suspicion thereof
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- Presence or history of hepatic tumors
- Acute or chronic hepatic disease
- Presence of renal diseases with renal failure
- Changes in biochemical or hematological laboratory values in spite of lack of clinical manifestations, in the investigator's opinion
- Suspected lack of the patient's compliance
- Hypersensitivity to the active substance
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Scientific Centre for Endocrinology RAMS
Moscow, 117136
Svetlana Kalinchenko, PhD, +7(095)1244301, kalinchenko@list.ru
Yuliya Tishova, PhDstudent, +79032213276, yulya_tishova@mail.ru
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study With Open-Label Follow-up to Investigate the Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
The objective of the study is to assess the effect of the testosterone therapy on the body composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic syndrome and hypogonadism.
- Conditions
- Metabolic Syndrome, Hypogonadism
- Being tested
- Nebido (testosterone undecanoate), Placebo
- Keywords
- metabolic syndrome, hypogonadism, testosterone undecanoate
- Medical subject headings
- Metabolic Syndrome, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebido (testosterone undecanoate)Drug
Nebido (testosterone undecanoate) intramuscular 4 ml by scheme
PlaceboDrug
Placebo 4 mL intramuscular
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Men receiving Nebido Receives: Drug: Nebido (testosterone undecanoate) |
| 2 | Placebo comparator | Men receiving Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
waist-to-hip ratio
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startOct 2005
- Primary completionJan 2009 (estimated)
- Study completionDec 2010 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Svetlana Kalinchenko, PhD, Principal investigator, Scientific Center for Endocrinology, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696748
- Sponsor's protocol ID
- U00006KO
- Acronym
- NePlaM3
- Status last verified
- Jun 2008
- First submitted
- 11 Jun 2008
- Last updated
- 13 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Tishova Y, Kalinchenko S, Mskhalaya G, Hackett G, Livingston M, Konig C, Strange R, Zitzmann M, Mann A, Maarouf A, Ramachandran S. Testosterone therapy reduces insulin resistance in men with adult-onset testosterone deficiency and metabolic syndrome. Results from the Moscow Study, a randomized controlled trial with an open-label phase. Diabetes Obes Metab. 2024 Jun;26(6):2147-2157. doi: 10.1111/dom.15520. Epub 2024 Mar 3.
PubMed 38433502Lee H, Hwang EC, Oh CK, Lee S, Yu HS, Lim JS, Kim HW, Walsh T, Kim MH, Jung JH, Dahm P. Testosterone replacement in men with sexual dysfunction. Cochrane Database Syst Rev. 2024 Jan 15;1(1):CD013071. doi: 10.1002/14651858.CD013071.pub2.
PubMed 38224135Kalinchenko SY, Tishova YA, Mskhalaya GJ, Gooren LJ, Giltay EJ, Saad F. Effects of testosterone supplementation on markers of the metabolic syndrome and inflammation in hypogonadal men with the metabolic syndrome: the double-blinded placebo-controlled Moscow study. Clin Endocrinol (Oxf). 2010 Nov;73(5):602-12. doi: 10.1111/j.1365-2265.2010.03845.x.
PubMed 20718771Giltay EJ, Tishova YA, Mskhalaya GJ, Gooren LJ, Saad F, Kalinchenko SY. Effects of testosterone supplementation on depressive symptoms and sexual dysfunction in hypogonadal men with the metabolic syndrome. J Sex Med. 2010 Jul;7(7):2572-82. doi: 10.1111/j.1743-6109.2010.01859.x. Epub 2010 May 26.
PubMed 20524974
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study With Open-Label Follow-up to Investigate the Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
- ClinicalTrials.gov ID
- NCT00696748
- Acronym / sponsor ID
- NePlaM3 / U00006KO
- Conditions
- Metabolic Syndrome, Hypogonadism
- Keywords
- metabolic syndrome, hypogonadism, testosterone undecanoate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 13 Jun 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.
The objective of the study is to assess the effect of the testosterone therapy on the body composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic syndrome and hypogonadism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Nebido (testosterone undecanoate)Men receiving Nebido |
| 2 | Placebo comparator | Drug: PlaceboMen receiving Placebo |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A signed informed consent to participate in the study
- Men aged 35 to 70 with testosterone levels below 12 nmol/L or free testosterone below 225 pmol/L
- Presence of the metabolic syndrome according to the IDF definition
Key exclusion criteria (12 listed)
- Patients under 35 or above 70 years.
- Participation in any clinical study within 30 days before the first injection of the drug
- Simultaneous participation in another clinical study
- Incapable subjects as well as prisoners
- Suspicion of a serious organic or mental disease according to medical history and/or clinical examination
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 |
|---|---|---|
| Nebido (testosterone undecanoate)Nebido (testosterone undecanoate) intramuscular 4 ml by scheme | Drug | 1 |
| PlaceboPlacebo 4 mL intramuscular | Drug | 2 |
Primary outcome
waist-to-hip ratio
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2008.
- Derived from this study: PubMed 38433502Tishova Y, Kalinchenko S, Mskhalaya G, Hackett G, Livingston M, Konig C, Strange R, Zitzmann M, Mann A, Maarouf A, Ramachandran S. Testosterone therapy reduces insulin resistance in men with adult-onset testosterone deficiency and metabolic syndrome. Results from the Moscow Study, a randomized controlled trial with an open-label phase. Diabetes Obes Metab. 2024 Jun;26(6):2147-2157. doi: 10.1111/dom.15520. Epub 2024 Mar 3.
- Derived from this study: PubMed 38224135Lee H, Hwang EC, Oh CK, Lee S, Yu HS, Lim JS, Kim HW, Walsh T, Kim MH, Jung JH, Dahm P. Testosterone replacement in men with sexual dysfunction. Cochrane Database Syst Rev. 2024 Jan 15;1(1):CD013071. doi: 10.1002/14651858.CD013071.pub2.
- Derived from this study: PubMed 20718771Kalinchenko SY, Tishova YA, Mskhalaya GJ, Gooren LJ, Giltay EJ, Saad F. Effects of testosterone supplementation on markers of the metabolic syndrome and inflammation in hypogonadal men with the metabolic syndrome: the double-blinded placebo-controlled Moscow study. Clin Endocrinol (Oxf). 2010 Nov;73(5):602-12. doi: 10.1111/j.1365-2265.2010.03845.x.
- Derived from this study: PubMed 20524974Giltay EJ, Tishova YA, Mskhalaya GJ, Gooren LJ, Saad F, Kalinchenko SY. Effects of testosterone supplementation on depressive symptoms and sexual dysfunction in hypogonadal men with the metabolic syndrome. J Sex Med. 2010 Jul;7(7):2572-82. doi: 10.1111/j.1743-6109.2010.01859.x. Epub 2010 May 26.
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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.
Svetlana Kalinchenko, PhD principal investigator
Scientific Center for Endocrinology, Russia
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 Nebido (testosterone undecanoate) in people with Metabolic Syndrome and Hypogonadism, run by Russian Academy of Medical Sciences at 1 site in Russia.
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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 13 Jun 2008. 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 Russia. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Svetlana Kalinchenko, PhD (+70951244301, kalinchenko@list.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
waist-to-hip ratio (time frame: 3 years). 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 NCT00696748, 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 13 Jun 2008.