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| ID | Type | Description | Link |
|---|---|---|---|
| DEPO-T BE STUDY | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Treatment A | Experimental | Single 200mg IM testosterone cypionate solution (Test formulation) |
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| Part 1: Treatment B | Active Comparator | Single 200 mg IM testosterone cypionate solution (Reference formulation) |
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| Part 2: Treatment A | Experimental | Single 200 mg IM testosterone cypionate solution (Test formulation) |
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| Part 2: Treatment B | Active Comparator | Single 200 mg IM testosterone cypionate solution (Reference formulation) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test formulation | Biological | A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
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.
Exclusion Criteria:
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.
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avail Clinical Research | DeLand | Florida | 32720 | United States | ||
| Syneos Health |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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This study was a multi-period crossover study. In Part 1, there were 2 treatment periods with a washout period of 45 days. In Part 2, there were 3 treatment periods with 2 washout periods of 45 days each.
There were 2 parts in the study, different participants were enrolled into the 2 individual parts.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Treatment A>Treatment B | This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (intramuscular [IM]) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 1, where participants received the treatments in the order of A, B. |
| FG001 | Part 1: Treatment B>Treatment A | This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 2, where participants received the treatments in the order of B, A. |
| FG002 | Part 2: Treatment A>Treatment B>Treatment B | This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 1, where participants received the treatments in the order of A, B, B. |
| FG003 | Part 2: Treatment B>Treatment A>Treatment B | This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 2, where participants received the treatments in the order of B, A, B. |
| FG004 | Part 2: Treatment B>Treatment B>Treatment A | This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 3, where participants received the treatments in the order of B, B, A. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The baseline analysis population included all participants enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Treatment A>Treatment B | This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 1, where participants received the treatments in the order of A, B. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | 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. |
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From the signing of informed consent through and including a minimum of 28 calendar days and up to 35 calendar days after the last administration of the investigational product.
Serious adverse events (SAEs) and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial (CT) SAE report form to Pfizer Safety within 24 hours of awareness.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A (Parts 1 and 2) | This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This group included the participants enrolled in both Part 1 and Part 2 of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 18007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 6, 2019 | Apr 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2020 | Apr 2, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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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
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| Reference formulation | Biological | A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation). |
|
| 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. | 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. | 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. |
| Miami |
| Florida |
| 33136 |
| United States |
| Lost to Follow-up |
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| Other |
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| BG001 | Part 1: Treatment B>Treatment A | This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 1 Sequence 2, where participants received the treatments in the order of B, A. |
| BG002 | Part 2: Treatment A>Treatment B>Treatment B | This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 1, where participants received the treatments in the order of A, B, B. |
| BG003 | Part 2: Treatment B>Treatment A>Treatment B | This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 2, where participants received the treatments in the order of B, A, B. |
| BG004 | Part 2: Treatment B>Treatment B>Treatment A | This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This is the Part 2 Sequence 3, where participants received the treatments in the order of B, B, A. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Treatment B | This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. |
|
|
| Primary | 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. | The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 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. |
|
|
|
| Primary | 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. | The analysis population included all participants randomized and treated who had at least 1 concentration in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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. |
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|
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| Primary | 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. | The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 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. |
|
|
|
| Primary | 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. | The analysis population included all participants randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 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. |
|
|
|
| Primary | 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. | The analysis population included all participants randomized and treated who had at least 1 concentration in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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. |
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| 0 |
| 71 |
| 0 |
| 71 |
| 7 |
| 71 |
| EG001 | Treatment B (Parts 1 and 2) | This was a 2-part study, participants were enrolled in the 2 parts to receive Treatment A and Treatment B in different sequence. Treatment A (Test) was a single testosterone cypionate solution (new formulation) 200 mg dose administered for injection (IM) deep in the gluteal muscle. Treatment B (Reference) was a single testosterone cypionate solution for injection (currently marketed formulation) 200 mg administered IM deep in the gluteal muscle. This group included the participants enrolled in both Part 1 and Part 2 of the study. | 0 | 72 | 0 | 72 | 1 | 72 |
| Lip disorder | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
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| Skin Abrasion | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.