HypogonadismPhase 3NCT01786473
Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
A Phase 3 study testing Testogel 1% in people with Hypogonadism, run by Laboratoires Besins International at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Testogel® 50mg/5g gel administered once daily (QD, morning dosing) compared to placebo administered once daily (QD, morning dosing), for 3 months, in hypogonadal men with testosterone deficiency being confirmed by clinical features and biochemical… Read more about this study
- Who is it for?
- Ages 18 to 68 years, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Testogel 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 2014
- 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 18 to 68 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male ages 18-68 years diagnosed as having testosterone deficiency with clinical symptoms
- A morning (8:00-10:00) serum Total Testosterone concentration of ≤ 300 ng/dL, confirmed by a second measurement of morning serum Total Testosterone concentration ≤ 300 ng/dL (samples to be taken 1 - 3 weeks apart)
Who cannot join
- Abnormal prostate as evidenced by prostatic symptoms, prostatic masses or induration on rectal examination, or elevated levels of prostate specific antigen (PSA > 4ng/ml) or a maximum urine flow rate of less than 12 ml/sec(of a urine volume greater than 150ml) (and/or an International Prostate Symptom Score IPSS score >19)
- Hematocrit > 50%
- Major psychiatric illness
- Unable to understand the protocol or to give informed consent
- Use of paroxetine and clomipramine
- Active alcoholism
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- History of drug abuse within the past five years;
- Use of drugs that might interfere with the results of the study (e.g., antiandrogen, estrogens or P 450 enzyme inducers, barbiturates);
- BMI < 18 or > 30 according to Chinese BMI references;
- Generalized skin disease that may affect absorption of T (e.g., psoriasis) or a known skin intolerance to alcohol;
- Prolactin > 40 mcg/L;
- Untreated severe obstructive sleep apnea;.
- Uncontrolled or poorly controlled heart failure
Trial locations and contacts
1 site in 1 country.
Ellen Dhoore contact
About this study
Official title: A Multi-center, Double Blind, Randomized, Placebo Controlled Study of Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
The purpose of this study is to evaluate the safety and efficacy of Testogel® 50mg/5g gel administered once daily (QD, morning dosing) compared to placebo administered once daily (QD, morning dosing), for 3 months, in hypogonadal men with testosterone deficiency being confirmed by clinical features and biochemical tests. For men with hypogonadism, treatment aims to restore testosterone levels to normal physiological range.
- Conditions
- Hypogonadism
- Being tested
- Testogel 1%, Placebo
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testogel 1%Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Testogel 1% 5g QD | Experimental | Not described Receives: Drug: Testogel 1% |
| Placebo gel 5g QD | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with morning serum Total Testosterone concentration within the physiological range (300 - 1000 ng/dL or 10.4 - 34.7 nmol/L) after 3 months of Testogel treatment compared to placebo-treatment
Measured: 3 months
Secondary outcomes (5)
morning serum Total Testosterone (TT) concentration compared to placebo treatment
Measured: 3 months
morning serum Total Testosterone (TT) concentration compared to baseline values
Measured: 3 months
serum concentrations of TT, calculated free testosterone (cFT), DHT, E2, LH, and FSH, SHBG
Measured: 3 months
prostate assessments (PSA, urine flow rate, DRE, ultrasound B)
Measured: 3 months
skin integrity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Besins International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Jin, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786473
- Sponsor's protocol ID
- 01BHR11
- Status last verified
- Feb 2013
- First submitted
- 6 Feb 2013
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double Blind, Randomized, Placebo Controlled Study of Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
- ClinicalTrials.gov ID
- NCT01786473
- Acronym / sponsor ID
- 01BHR11
- Conditions
- Hypogonadism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Laboratoires Besins InternationalIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (estimated)
- First posted
- 8 Feb 2013 (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 safety and efficacy of Testogel® 50mg/5g gel administered once daily (QD, morning dosing) compared to placebo administered once daily (QD, morning dosing), for 3 months, in hypogonadal men with testosterone deficiency being confirmed by clinical features and biochemical tests. For men with hypogonadism, treatment aims to restore testosterone levels to normal physiological range.
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 |
|---|---|---|
| Testogel 1% 5g QD | Experimental | Drug: Testogel 1% |
| Placebo gel 5g QD | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male ages 18-68 years diagnosed as having testosterone deficiency with clinical symptoms
- A morning (8:00-10:00) serum Total Testosterone concentration of ≤ 300 ng/dL, confirmed by a second measurement of morning serum Total Testosterone concentration ≤ 300 ng/dL (samples to be taken 1 - 3 weeks apart)
Key exclusion criteria (13 listed)
- Abnormal prostate as evidenced by prostatic symptoms, prostatic masses or induration on rectal examination, or elevated levels of prostate specific antigen (PSA > 4ng/ml) or a maximum urine flow rate of less than 12 ml/sec(of a urine volume greater than 150ml) (and/or an International Prostate Symptom Score IPSS score >19)
- Hematocrit > 50%
- Major psychiatric illness
- Unable to understand the protocol or to give informed consent
- Use of paroxetine and clomipramine
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 1% | Drug | Testogel 1% 5g QD |
| Placebo | Drug | Placebo gel 5g QD |
Primary outcome
Percentage of patients with morning serum Total Testosterone concentration within the physiological range (300 - 1000 ng/dL or 10.4 - 34.7 nmol/L) after 3 months of Testogel treatment compared to placebo-treatment
Time frame: 3 months
5 secondary outcomes
morning serum Total Testosterone (TT) concentration compared to placebo treatment
Time frame: 3 months
morning serum Total Testosterone (TT) concentration compared to baseline values
Time frame: 3 months
serum concentrations of TT, calculated free testosterone (cFT), DHT, E2, LH, and FSH, SHBG
Time frame: 3 months
prostate assessments (PSA, urine flow rate, DRE, ultrasound B)
Time frame: 3 months
skin integrity
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
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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.
Ellen Dhoore contact
Jie Jin principal investigator
Peking University First Hospital
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 Testogel 1% in people with Hypogonadism, run by Laboratoires Besins International at 1 site in China.
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 13 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 8 Feb 2013. 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 China. 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 Ellen Dhoore (edhoore@besins-healthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with morning serum Total Testosterone concentration within the physiological range (300 - 1000 ng/dL or 10.4 - 34.7 nmol/L) after 3 months of Testogel treatment compared to placebo-treatment (time frame: 3 months). 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 8 Feb 2013.