Primary HypogonadismPhase 3NCT02110368
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
A Phase 3 study testing Testosterone Topical Gel, 1.62% Metered Pump and AndroGel (testosterone gel) 1.62% Metered-Dose Pump in people with Primary Hypogonadism and Hypogonadotropic Hypogonadism, run by Amneal Pharmaceuticals, LLC at 1 site in United States.
Trial summary
Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Primary Hypogonadism, Hypogonadotropic Hypogonadism
- What is being tested?
- Testosterone Topical Gel, 1.62% Metered Pump and AndroGel (testosterone gel) 1.62% Metered-Dose Pump
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to May 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adult men with hypogonadism with testosterone levels <250ng/dL
- 18 to 65 years of age (inclusive)
- Have normal PSA < 4.0ng/mL
- Weighing a minimum of 50 kg and having a body mass index between 18.0 and 38.0 kg/m2.
- Good health as determined by medical history and lack of clinically significant abnormalities (other than hypogonadism).
- Vital signs, must be within the following ranges heart rate: 45-100 bpm; systolic BP: 90-150 mmHg; diastolic BP: 50-90 mmHg. Out-of-range vital signs may be repeated.
Who cannot join
- Is female
- History of allergy or sensitivity to AndroGel® or any component of drug or a related testosterone drug, Axiron®, Testim®, etc.
- History of allergy or intolerance to soy, soybean, and/or soy lecithin
- History of any drug or food hypersensitivity or intolerance which, would compromise the safety of the subject or the study.
- History or presence of clinically significant ocular, cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any othercondition that, would jeopardize the safety of the subject or the validity of the study results.
- Had no major surgery or illness within 3 months before screening.
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- History or presence of benign prostate hypertrophy, prostate and/or breast cancer.
- Has tattooed, damaged, scarred skin or any skin condition on right or left upper arm and shoulder region that may affect absorption of drug.
- Has a clinically significant abnormal finding on the physical exam, medical history, electrocardiogram or clinical laboratory results at screening.
- Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
- Has donated blood within 56 days or plasma within 30 days prior to the first dose of study medication.
- Has participated in another clinical trial within 30 days prior to the first dose of study medication.
- Has used any over-the-counter medication, including nutritional supplements, within 7 days prior to the first dose of study medication.
- Has used any prescription medication including hormonal treatment and or supplement within 30 days prior to the first dose of study medication.
- No depot injections or drug implants within 3 months of first dose of study medication.
- Has been treated with any known drugs that are moderate or strong inhibitors/inducers of CYP enzymes such as barbiturates, phenothiazine, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication and that may impact subject safety or the validity of the study results.
- Has positive cotinine test and/or smoked or used tobacco products within 60 days prior to the first dose of study medication
- Has a positive urine screen for drugs of abuse
- Has positive alcohol breathalyzer test
- Has a positive test for Hepatitis B surface antigen, Hepatitis C antibody, or Human Immunodeficiency Virus (HIV) at screening or has been previously treated for Hepatitis B, Hepatitis C, or HIV infection.
- Any difficulty fasting or has any dietary restrictions such as lactose intolerance, vegan, low-fat, etc.
- Unavailable for any confinement days or scheduled visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Phase One Solutions, Inc.
Miami Gardens, Florida, 33169
About this study
Official title: An Open-Label, Randomized, Balanced, Single-Dose, Two Treatment, Four Period, Two Sequence Replicate Design, Bioequivalence Study Of Testosterone Topical Gel, 1.62% Metered Pump, Manufactured By Amneal Pharmaceuticals LLC With AndroGel (Testosterone Gel) 1.62% Metered-Dose Pump, Marketed By Abbvie Inc., In Testosterone-Deficient (Hypogonadal) Adult Male Subjects Under Fasting Conditions
Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.
Read the detailed description
To compare the rate and extent of testosterone absorption for a test formulation of Testosterone Topical Gel, 1.62% Metered Pump, manufactured with that of AndroGel® (testosterone gel) 1.62% Metered-Dose Pump, in normal, healthy, adult, testosterone-deficient (hypogonadal) human male subjects under fasting conditions.
- Being tested
- Testosterone Topical Gel, 1.62% Metered Pump, AndroGel (testosterone gel) 1.62% Metered-Dose Pump
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Topical Gel, 1.62% Metered PumpDrug
AndroGel (testosterone gel) 1.62% Metered-Dose PumpDrug
| Study group | Role | What they receive |
|---|---|---|
| AndroGel | Active comparator | AndroGel (testosterone gel) 1.62% Metered-Dose Pump. One actuation 20.25 mg Receives: Drug: AndroGel (testosterone gel) 1.62% Metered-Dose Pump |
| Testosterone Gel | Experimental | Testosterone Topical Gel, 1.62% Metered Pump. One actuation of 20.25 mg. Receives: Drug: Testosterone Topical Gel, 1.62% Metered Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Area under the concentration vs. time curve, from the time of first dosing to the time of the last measured concentration.
Measured: Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours
AUC0-inf
Area under the concentration vs. time curve, from time of first dosing to infinity
Measured: Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours
Cmax
Maximum reported concentration. Estimated for both baseline
Measured: Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours
Secondary outcomes (3)
Tmax
Time at which Cmax is first observed
Measured: Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours
Kel
Apparent first order terminal elimination rate constant determined from the terminal log-linear concentration-time data
Measured: Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours
T 1/2
Terminal elimination half-life
Measured: Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amneal Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Phase One Solutions, Inc.
- Responsible party
- Sponsor
- Investigators
- Lawrence Galitz, MD, Principal investigator, Phae 1 Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110368
- Sponsor's protocol ID
- AL1401
- Status last verified
- Jun 2014
- First submitted
- 8 Apr 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Balanced, Single-Dose, Two Treatment, Four Period, Two Sequence Replicate Design, Bioequivalence Study Of Testosterone Topical Gel, 1.62% Metered Pump, Manufactured By Amneal Pharmaceuticals LLC With AndroGel (Testosterone Gel) 1.62% Metered-Dose Pump, Marketed By Abbvie Inc., In Testosterone-Deficient (Hypogonadal) Adult Male Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT02110368
- Acronym / sponsor ID
- AL1401
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Amneal Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Phase One Solutions, Inc.
- Study start
- Mar 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Apr 2014 (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.
Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.
Detailed description
To compare the rate and extent of testosterone absorption for a test formulation of Testosterone Topical Gel, 1.62% Metered Pump, manufactured with that of AndroGel® (testosterone gel) 1.62% Metered-Dose Pump, in normal, healthy, adult, testosterone-deficient (hypogonadal) human male subjects under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AndroGel | Active comparator | Drug: AndroGel (testosterone gel) 1.62% Metered-Dose PumpAndroGel (testosterone gel) 1.62% Metered-Dose Pump. One actuation 20.25 mg |
| Testosterone Gel | Experimental | Drug: Testosterone Topical Gel, 1.62% Metered PumpTestosterone Topical Gel, 1.62% Metered Pump. One actuation of 20.25 mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adult men with hypogonadism with testosterone levels <250ng/dL
- 18 to 65 years of age (inclusive)
- Have normal PSA < 4.0ng/mL
- Weighing a minimum of 50 kg and having a body mass index between 18.0 and 38.0 kg/m2.
- Good health as determined by medical history and lack of clinically significant abnormalities (other than hypogonadism).
Key exclusion criteria (22 listed)
- Is female
- History of allergy or sensitivity to AndroGel® or any component of drug or a related testosterone drug, Axiron®, Testim®, etc.
- History of allergy or intolerance to soy, soybean, and/or soy lecithin
- History of any drug or food hypersensitivity or intolerance which, would compromise the safety of the subject or the study.
- History or presence of clinically significant ocular, cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any othercondition that, would jeopardize the safety of the subject or the validity of the study results.
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 |
|---|---|---|
| Testosterone Topical Gel, 1.62% Metered Pump | Drug | Testosterone Gel |
| AndroGel (testosterone gel) 1.62% Metered-Dose Pump | Drug | AndroGel |
Primary outcome
AUC0-t
Time frame: Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours
Area under the concentration vs. time curve, from the time of first dosing to the time of the last measured concentration.
AUC0-inf
Time frame: Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours
Area under the concentration vs. time curve, from time of first dosing to infinity
Cmax
Time frame: Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours
Maximum reported concentration. Estimated for both baseline
3 secondary outcomes
Tmax
Time frame: Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours
Kel
Time frame: Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours
T 1/2
Time frame: Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours
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 26 Jun 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.
Lawrence Galitz, MD principal investigator
Phae 1 Solutions
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 Testosterone Topical Gel, 1.62% Metered Pump and AndroGel (testosterone gel) 1.62% Metered-Dose Pump in people with Primary Hypogonadism and Hypogonadotropic Hypogonadism, run by Amneal Pharmaceuticals, LLC at 1 site in United States.
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 6 inclusion and 22 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 26 Jun 2014. 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 United States. 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 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?
AUC0-t (time frame: Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours). The study lists 3 primary outcomes in all. 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 26 Jun 2014.