HypogonadismPhase 2NCT00434824
Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)
A Phase 2 study testing Oral testosterone undecanoate (Andriol) in people with Hypogonadism and Androgens, run by Merck Sharp & Dohme LLC.
Trial summary
In this study we have evaluated the effects of three different doses of oral testosterone undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism and low blood levels of the male hormone testosterone. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Hypogonadism, Androgens
- What is being tested?
- Oral testosterone undecanoate (Andriol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- No sites listed yet
- Study dates
- Nov 2001to Jul 2004
- Phase
- Phase 2
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects were at least 50 years of age
- A body mass index (BMI) between 18 and 34 kg/m^2
- Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire)
- Calculated free testosterone measurement of <0.26 nmol/L in the morning
Who cannot join
- History or current diagnosis of breast or prostate cancer
- any clinically significant abnormal finding on physical examination including the prostate
- Clinical symptoms of obstructive benign prostate hyperplasia (International Prostate Symptom Score (IPSS) >14)
- Prostate specific antigen (PSA) level > 4 ng/mL at screening
- Cause of androgen deficiency other than aging, e.g. 'classical' diagnosis of primary or secondary hypogonadism
- Hyperprolactinaemia or treatment with prolactin-lowering drugs
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- History of known chronic polycythemia and/or hematocrit >50% at screening
- History or presence of severe sleep apnea
- Unstable or untreated endocrine disorders
- History or presence of clinically significant depression or other psychiatric disorder or any clinically relevant cardiovascular, cerebrovascular, endocrine, hepatic, renal or hematological disease, thromboembolism/thrombosis etc. which, in the opinion of the investigator, might compromise the subject's participation in the trial
- Use of medication that would interfere with the efficacy and safety objectives of the trial
About this study
Official title: A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Oral Administration of Different Doses of Org 538 in Symptomatic Aging Men With Androgen Deficiency
In this study we have evaluated the effects of three different doses of oral testosterone undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism and low blood levels of the male hormone testosterone.
Specifically, we have studied the effects on:
- symptoms suggestive of low testosterone levels
- blood testosterone and other hormone levels
- bone mass
- muscle mass and fat mass
- muscle strength
- prostate
- lipids, hematocrit
- Conditions
- Hypogonadism, Androgens
- Being tested
- Oral testosterone undecanoate (Andriol), Placebo
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral testosterone undecanoate (Andriol)Drug
Also called Org 538
treatment for 12 months with oral TU 80 mg/d, oral TU 160 mg/d or oral TU 240 mg/d in divided doses
PlaceboDrug
treatment for 12 months with placebo in divided doses
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Oral testosterone undecanoate (Andriol) Receives: Drug: Oral testosterone undecanoate (Andriol) |
| Arm 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the total score of the AMS rating scale
Measured: Month 6
Secondary outcomes (1)
Effects on AMS rating scale, bone mineral density, bone markers, muscle and fat mass, muscle strength, hematocrit, endocrine parameters, PSA, IPSS and lipids
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startNov 2001
- Primary completionJul 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434824
- Sponsor's protocol ID
- 43203
- Status last verified
- Apr 2015
- First submitted
- 12 Feb 2007
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Meuleman EJ, Legros JJ, Bouloux PM, Johnson-Levonas AO, Kaspers MJ, Elbers JM, Geurts TB, Meehan AG; Study 43203 Investigators. Effects of long-term oral testosterone undecanoate therapy on urinary symptoms: data from a 1-year, placebo-controlled, dose-ranging trial in aging men with symptomatic hypogonadism. Aging Male. 2015;18(3):157-63. doi: 10.3109/13685538.2015.1032925. Epub 2015 Jun 1.
PubMed 26030346Bouloux PM, Legros JJ, Elbers JM, Geurts TB, Kaspers MJ, Meehan AG, Meuleman EJ; Study 43203 Investigators. Effects of oral testosterone undecanoate therapy on bone mineral density and body composition in 322 aging men with symptomatic testosterone deficiency: a 1-year, randomized, placebo-controlled, dose-ranging study. Aging Male. 2013 Jun;16(2):38-47. doi: 10.3109/13685538.2013.773420. Epub 2013 Apr 12.
PubMed 23581697
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Oral Administration of Different Doses of Org 538 in Symptomatic Aging Men With Androgen Deficiency
- ClinicalTrials.gov ID
- NCT00434824
- Acronym / sponsor ID
- 43203
- Conditions
- Hypogonadism, Androgens
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 13 Feb 2007 (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 we have evaluated the effects of three different doses of oral testosterone undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism and low blood levels of the male hormone testosterone.
Specifically, we have studied the effects on:
- symptoms suggestive of low testosterone levels
- blood testosterone and other hormone levels
- bone mass
- muscle mass and fat mass
- muscle strength
- prostate
- lipids, hematocrit
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 |
|---|---|---|
| Arm 1 | Active comparator | Drug: Oral testosterone undecanoate (Andriol)Oral testosterone undecanoate (Andriol) |
| Arm 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects were at least 50 years of age
- A body mass index (BMI) between 18 and 34 kg/m^2
- Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire)
- Calculated free testosterone measurement of <0.26 nmol/L in the morning
Key exclusion criteria (11 listed)
- History or current diagnosis of breast or prostate cancer
- any clinically significant abnormal finding on physical examination including the prostate
- Clinical symptoms of obstructive benign prostate hyperplasia (International Prostate Symptom Score (IPSS) >14)
- Prostate specific antigen (PSA) level > 4 ng/mL at screening
- Cause of androgen deficiency other than aging, e.g. 'classical' diagnosis of primary or secondary hypogonadism
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 |
|---|---|---|
| Oral testosterone undecanoate (Andriol)Also: Org 538treatment for 12 months with oral TU 80 mg/d, oral TU 160 mg/d or oral TU 240 mg/d in divided doses | Drug | Arm 1 |
| Placebotreatment for 12 months with placebo in divided doses | Drug | Arm 2 |
Primary outcome
Change from baseline on the total score of the AMS rating scale
Time frame: Month 6
1 secondary outcome
Effects on AMS rating scale, bone mineral density, bone markers, muscle and fat mass, muscle strength, hematocrit, endocrine parameters, PSA, IPSS and lipids
Time frame: Month 12
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 Apr 2015.
- Derived from this study: PubMed 26030346Meuleman EJ, Legros JJ, Bouloux PM, Johnson-Levonas AO, Kaspers MJ, Elbers JM, Geurts TB, Meehan AG; Study 43203 Investigators. Effects of long-term oral testosterone undecanoate therapy on urinary symptoms: data from a 1-year, placebo-controlled, dose-ranging trial in aging men with symptomatic hypogonadism. Aging Male. 2015;18(3):157-63. doi: 10.3109/13685538.2015.1032925. Epub 2015 Jun 1.
- Derived from this study: PubMed 23581697Bouloux PM, Legros JJ, Elbers JM, Geurts TB, Kaspers MJ, Meehan AG, Meuleman EJ; Study 43203 Investigators. Effects of oral testosterone undecanoate therapy on bone mineral density and body composition in 322 aging men with symptomatic testosterone deficiency: a 1-year, randomized, placebo-controlled, dose-ranging study. Aging Male. 2013 Jun;16(2):38-47. doi: 10.3109/13685538.2013.773420. Epub 2013 Apr 12.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral testosterone undecanoate (Andriol) in people with Hypogonadism and Androgens, run by Merck Sharp & Dohme LLC.
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 11 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 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline on the total score of the AMS rating scale (time frame: Month 6). 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 NCT00434824, which also lists 2 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 16 Apr 2015.