Androgens (Deficiency)Phase 3NCT00185198
Efficacy and Safety of Testogel® in Men With Partial Androgen Deficiency of Aging Males (PADAM)
A Phase 3 study testing Testogel (Testosterone, BAYV001915) in people with Androgens (Deficiency) and Male, run by Bayer at 30 sites in 8 countries.
Trial summary
The purpose of this study is to investigate the effect of a testosterone replacement therapy called Testogel in men with PADAM. The effects on body composition (lean, fat and bone) and other symptoms of PADAM and safety will be studied. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Androgens (Deficiency), Male
- What is being tested?
- Testogel (Testosterone, BAYV001915)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 363 participants
- Where
- 30 sitesin 8 countries
- Study dates
- Sep 2004to Oct 2007
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic hypogonadism
- Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study
Who cannot join
- Patients with any contraindication for testosterone use
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
United Kingdom6 sites
Study site
Cardiff, CF14 5GJ
Study site
London, EC1A 7BE
Study site
London, NW3 2QG
Study site
Reading, Berkshire, RG2 7AG
Study site
Sheffield, S5 7AU
Study site
Wigan, Manchester, WN1 1XX
Austria5 sites
Study site
Graz, 8036
Study site
Innsbruck, 6020
Study site
Salzburg, 5020
Study site
Vienna, State of Vienna, 1090
Study site
Vienna, 1021
Germany5 sites
Study site
Bonn, North Rhine-Westphalia, 53105
Study site
Dresden, Saxony, 01067
Study site
Halle, Saxony-Anhalt, 06112
Study site
Leipzig, Saxony, 04103
Study site
Magdeburg, 39310
Italy4 sites
Study site
Milan, 20123
Study site
Naples, 80131
Study site
Roma, 00161
Study site
Roma, 00186
Finland3 sites
Study site
Helsinki, 00260
Study site
Oulu, 90100
Study site
Tampere, 33521
Spain3 sites
Study site
Barcelona, 08025
Study site
L'Hospitalet de Llobregat, Barcelona, 08907
Study site
Madrid, Madrid, 28007
Sweden3 sites
Study site
Gothenburg, 41346
Study site
Malmö, 20502
Study site
Stockholm, 14186
About this study
Official title: Multicenter, Double Blind, Randomized, Placebo Controlled Study of Testogel® (Testosterone 50-100mg) to Evaluate Its Efficacy and Safety in Men Presenting With Typical Symptoms of Partial Androgen Deficiency of Aging Males (PADAM) Over a Period of 6 Months With 12 Months Open Label Follow-up
The purpose of this study is to investigate the effect of a testosterone replacement therapy called Testogel in men with PADAM. The effects on body composition (lean, fat and bone) and other symptoms of PADAM and safety will be studied.
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Androgens (Deficiency), Male
- Being tested
- Testogel (Testosterone, BAYV001915), Placebo
- Keywords
- Partial androgen deficiency of aging males (PADAM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testogel (Testosterone, BAYV001915)Drug
50mg (5g gel sachet), 75mg (5g+2.5g sachet) or 100mg (2x5g sachet) per day applied to the skin of the shoulders, arms or abdomen for 18 months
PlaceboDrug
5g gel sachet, 5g+2.5g sachet or 2x5g sachets per day applied to the skin of the shoulders, arms or abdomen for 6 months followed by 12 months treatment with testosterone 1% gel as described for arm 1
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: Testogel (Testosterone, BAYV001915) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean body mass at 6 months
Measured: baseline, month 6 and month 18
Secondary outcomes (4)
Change in total body mass, fat mass and bone density
Measured: baseline, month 6 and month 18
Evaluation of symptoms by the aging males symptoms rating scale
Measured: baseline, month 6 and month 18
Change in testosterone
Measured: baseline, month 6 and month 18
Safety parameters
Measured: baseline, month 6 and month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionSep 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgens (Deficiency)Studies of the same condition, open and under way.
- More trials run by BayerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185198
- Sponsor's protocol ID
- 91297
- Other IDs
- 2004-001545-15, 307720, 2004
- Status last verified
- Apr 2014
- First submitted
- 9 Sep 2005
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double Blind, Randomized, Placebo Controlled Study of Testogel® (Testosterone 50-100mg) to Evaluate Its Efficacy and Safety in Men Presenting With Typical Symptoms of Partial Androgen Deficiency of Aging Males (PADAM) Over a Period of 6 Months With 12 Months Open Label Follow-up
- ClinicalTrials.gov ID
- NCT00185198
- Acronym / sponsor ID
- 91297
- Conditions
- Androgens (Deficiency), Male
- Keywords
- Partial androgen deficiency of aging males (PADAM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 16 Sep 2005 (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 investigate the effect of a testosterone replacement therapy called Testogel in men with PADAM. The effects on body composition (lean, fat and bone) and other symptoms of PADAM and safety will be studied.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Testogel (Testosterone, BAYV001915) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic hypogonadism
- Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study
Key exclusion criteria (1 listed)
- Patients with any contraindication for testosterone use
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 |
|---|---|---|
| Testogel (Testosterone, BAYV001915)50mg (5g gel sachet), 75mg (5g+2.5g sachet) or 100mg (2x5g sachet) per day applied to the skin of the shoulders, arms or abdomen for 18 months | Drug | Arm 1 |
| Placebo5g gel sachet, 5g+2.5g sachet or 2x5g sachets per day applied to the skin of the shoulders, arms or abdomen for 6 months followed by 12 months treatment with testosterone 1% gel as described for arm 1 | Drug | Arm 2 |
Primary outcome
Lean body mass at 6 months
Time frame: baseline, month 6 and month 18
4 secondary outcomes
Change in total body mass, fat mass and bone density
Time frame: baseline, month 6 and month 18
Evaluation of symptoms by the aging males symptoms rating scale
Time frame: baseline, month 6 and month 18
Change in testosterone
Time frame: baseline, month 6 and month 18
Safety parameters
Time frame: baseline, month 6 and month 18
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 2 Apr 2014.
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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.
Bayer Study Director study director
Bayer
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Testogel (Testosterone, BAYV001915) in people with Androgens (Deficiency) and Male, run by Bayer at 30 sites in 8 countries.
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 2 inclusion and 1 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 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United Kingdom, Austria, Germany, Italy, Finland and 3 more countries. 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?
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 at 6 months (time frame: baseline, month 6 and month 18). 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 2 Apr 2014; AzTrials last refreshed its copy on 8 Nov 2026.