HypogonadismPhase 1NCT03792477
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
A Phase 1 study testing Test formulation and Reference formulation in people with Hypogonadism, run by Pfizer at 2 sites in United States.
Trial summary
This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection relative to the currently approved marked formulation (reference). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Test formulation and Reference formulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jan 2019to 2 Apr 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hypogonadal male subjects who, at the time of screening, are otherwise healthy and between the ages of 18 and 65 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, 12 lead electrocardiogram (ECG), or clinical laboratory tests.
- Hypogonadism is defined as serum testosterone levels below 2.5 ng/mL (250 ng/dL).
- Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Subjects who are currently being treated for hypogonadism. This is defined as either patients who have received a testosterone injectable product within the past 3 months or have used a transdermal or gel product within the past 2 weeks.
- A positive urine drug test.
- History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
- Screening supine BP greater than or equal to 140 mm Hg (systolic) or greater than or equal to 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is greater than or equal to 140 mm Hg (systolic) or greater than or equal to 90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.
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- Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
- Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level greater than or equal to 3 times the upper limit of normal (ULN).
- Total bilirubin level greater than or equal to 1.5 times the ULN; subject with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is less than or equal to ULN.
- Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol [Contraception (Section 4.3.4)] for the duration of the study and for at least 45 days after the last dose of investigational product.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product. As an exception, acetaminophen/paracetamol may be used at doses of greater than or equal to 1 g/day. Limited use of nonprescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case by case basis following approval by the sponsor.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
- History of sensitivity to heparin or heparin induced thrombocytopenia.
- Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
- Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Subjects with carcinoma of the breast.
- Subjects with known or suspected carcinoma of the prostate gland.
- Subjects who are hypersensitive to testosterone cypionate or its inactive ingredients.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Avail Clinical Research
DeLand, Florida, 32720
Syneos Health
Miami, Florida, 33136
About this study
Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-TREATMENT SINGLE-DOSE, CROSS-OVER STUDY, 2-PART DESIGN TO EVALUATE THE BIOEQUIVALENCE AND TOLERABILITY OF TESTOSTERONE CYPIONATE FOLLOWING INTRAMUSCULAR (IM) INJECTION IN HEALTHY HYPOGONADAL MALE SUBJECTS
This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection relative to the currently approved marked formulation (reference). In the first part of the study (Part 1), an estimate of the exposure variability will be evaluated for both test and reference. This will help guide sample size in Part 2. Part 2 will be powered to assess the BE of both test and reference formulations.
- Conditions
- Hypogonadism
- Being tested
- Test formulation, Reference formulation
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test formulationBiological
A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation).
Reference formulationBiological
A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation).
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Treatment A | Experimental | Single 200mg IM testosterone cypionate solution (Test formulation) Receives: Biological: Test formulation |
| Part 1: Treatment B | Active comparator | Single 200 mg IM testosterone cypionate solution (Reference formulation) Receives: Biological: Reference formulation |
| Part 2: Treatment A | Experimental | Single 200 mg IM testosterone cypionate solution (Test formulation) Receives: Biological: Test formulation |
| Part 2: Treatment B | Active comparator | Single 200 mg IM testosterone cypionate solution (Reference formulation) Receives: Biological: Reference formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected Area Under The Serum Concentration-time Profile From Time 0 to The Last Quantifiable Concentration (AUClast) of Total Testosterone (Part 1).
The AUClast of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Measured: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
Corrected AUC From Tme 0 Extrapolated to Infinite Time (AUCinf) of Total Testosterone (Part 1).
The AUCinf of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Measured: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
Corrected Maximum Observed Concentration (Cmax) of Total Testosterone (Part 1).
The Cmax of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Measured: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
Corrected AUClast of Total Testosterone (Part 2).
The AUClast of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Measured: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
Corrected AUCinf of Total Testosterone (Part 2).
The AUCinf of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Measured: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
Corrected Cmax of Total Testosterone (Part 2)
The Cmax of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Measured: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start19 Jan 2019
- Primary completion2 Apr 2020
- Study completion2 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is an open-label, randomized, 2-treatment, 2-period, single dose (200 mg), cross-over study, 2-part design to evaluate the bioequivalence and tolerability of a reformulated presentation of testosterone cypionate relative to a currently marketed and approved formulation
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792477
- Sponsor's protocol ID
- B5341002
- Other IDs
- DEPO-T BE STUDY
- Status last verified
- Apr 2021
- First submitted
- 2 Jan 2019
- Last updated
- 29 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-TREATMENT SINGLE-DOSE, CROSS-OVER STUDY, 2-PART DESIGN TO EVALUATE THE BIOEQUIVALENCE AND TOLERABILITY OF TESTOSTERONE CYPIONATE FOLLOWING INTRAMUSCULAR (IM) INJECTION IN HEALTHY HYPOGONADAL MALE SUBJECTS
- ClinicalTrials.gov ID
- NCT03792477
- Acronym / sponsor ID
- B5341002
- Conditions
- Hypogonadism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 3 Jan 2019 (actual)
- Results
- Posted 29 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection relative to the currently approved marked formulation (reference). In the first part of the study (Part 1), an estimate of the exposure variability will be evaluated for both test and reference. This will help guide sample size in Part 2. Part 2 will be powered to assess the BE of both test and reference formulations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is an open-label, randomized, 2-treatment, 2-period, single dose (200 mg), cross-over study, 2-part design to evaluate the bioequivalence and tolerability of a reformulated presentation of testosterone cypionate relative to a currently marketed and approved formulation
| Arm | Type | Receives |
|---|---|---|
| Part 1: Treatment A | Experimental | Biological: Test formulationSingle 200mg IM testosterone cypionate solution (Test formulation) |
| Part 1: Treatment B | Active comparator | Biological: Reference formulationSingle 200 mg IM testosterone cypionate solution (Reference formulation) |
| Part 2: Treatment A | Experimental | Biological: Test formulationSingle 200 mg IM testosterone cypionate solution (Test formulation) |
| Part 2: Treatment B | Active comparator | Biological: Reference formulationSingle 200 mg IM testosterone cypionate solution (Reference formulation) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hypogonadal male subjects who, at the time of screening, are otherwise healthy and between the ages of 18 and 65 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, 12 lead electrocardiogram (ECG), or clinical laboratory tests.
- Hypogonadism is defined as serum testosterone levels below 2.5 ng/mL (250 ng/dL).
- Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (21 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Subjects who are currently being treated for hypogonadism. This is defined as either patients who have received a testosterone injectable product within the past 3 months or have used a transdermal or gel product within the past 2 weeks.
- A positive urine drug test.
- History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
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 |
|---|---|---|
| Test formulationA single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation). | Biological | Part 1: Treatment A, Part 2: Treatment A |
| Reference formulationA single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation). | Biological | Part 1: Treatment B, Part 2: Treatment B |
Primary outcome
Corrected Area Under The Serum Concentration-time Profile From Time 0 to The Last Quantifiable Concentration (AUClast) of Total Testosterone (Part 1).
Time frame: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
The AUClast of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Corrected AUC From Tme 0 Extrapolated to Infinite Time (AUCinf) of Total Testosterone (Part 1).
Time frame: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
The AUCinf of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Corrected Maximum Observed Concentration (Cmax) of Total Testosterone (Part 1).
Time frame: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
The Cmax of total testosterone in Part 1 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Corrected AUClast of Total Testosterone (Part 2).
Time frame: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
The AUClast of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Corrected AUCinf of Total Testosterone (Part 2).
Time frame: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
The AUCinf of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Corrected Cmax of Total Testosterone (Part 2)
Time frame: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.
The Cmax of total testosterone in Part 2 of the study was observed directly from data. The baseline endogenous testosterone level was the mean of the 4 predose PK samples, an average baseline correction of endogenous total testosterone levels was calculated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test formulation and Reference formulation in people with Hypogonadism, run by Pfizer at 2 sites 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 5 inclusion and 21 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 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Corrected Area Under The Serum Concentration-time Profile From Time 0 to The Last Quantifiable Concentration (AUClast) of Total Testosterone (Part 1). (time frame: At -1, -0.5, -0.25, 0 hours predose and at 1, 8, 24, 36, 48, 72, 96, 120, 144, 168, 240, 336 and 480 hours postdose.). The study lists 6 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 29 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.