A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03792477
• Collaborator: (none)
• Enrollment: 74
• Locations: 2
• Arms: 4
• Actual Duration (Months): 14.4
• Patients Per Site: 37
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief 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). 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.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism	Biological: Test formulation; Biological: Reference formulation	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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 formulationThis 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)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Jan 19, 2019
• Actual Primary Completion Date: Apr 2, 2020
• Actual Study Completion Date: Apr 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: Treatment A Single 200mg IM testosterone cypionate solution (Test formulation)	Biological: Test formulation; A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation).
Active Comparator: Part 1: Treatment B Single 200 mg IM testosterone cypionate solution (Reference formulation)	Biological: Reference formulation; A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation).
Experimental: Part 2: Treatment A Single 200 mg IM testosterone cypionate solution (Test formulation)	Biological: Test formulation; A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation).
Active Comparator: Part 2: Treatment B Single 200 mg IM testosterone cypionate solution (Reference formulation)	Biological: Reference formulation; A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation).

Outcome Measures

Primary Outcome Measures

1. Corrected Area Under The Serum Concentration-time Profile From Time 0 to The Last Quantifiable Concentration (AUClast) of Total Testosterone (Part 1). [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.

2. Corrected AUC From Tme 0 Extrapolated to Infinite Time (AUCinf) of Total Testosterone (Part 1). [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.

3. Corrected Maximum Observed Concentration (Cmax) of Total Testosterone (Part 1). [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.

4. Corrected AUClast of Total Testosterone (Part 2). [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.

5. Corrected AUCinf of Total Testosterone (Part 2). [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.

6. Corrected Cmax of Total Testosterone (Part 2) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. 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).

1. Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).

2. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

3. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

1. 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).

2. 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.

3. A positive urine drug test.

4. 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.

5. 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).

6. 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.

7. 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.

8. 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.

1. 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.

2. 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.

3. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.

4. 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).

5. History of sensitivity to heparin or heparin induced thrombocytopenia.

6. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.

7. 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.

8. 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.

9. Subjects with carcinoma of the breast.

10. Subjects with known or suspected carcinoma of the prostate gland.

11. Subjects who are hypersensitive to testosterone cypionate or its inactive ingredients.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Avail Clinical Research	DeLand	Florida	United States	32720
2	Syneos Health	Miami	Florida	United States	33136

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Aug 6, 2019
• Statistical Analysis Plan - Apr 10, 2020

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03792477
• Other Study ID Numbers: B5341002; DEPO-T BE STUDY
• First Posted: Jan 3, 2019
• Last Update Posted: Apr 29, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hypogonadism

Study Results

Participant Flow

Recruitment Details	There were 2 parts in the study, different participants were enrolled into the 2 individual parts.
Pre-assignment Detail	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.

Arm/Group Title	Part 1: Treatment A>Treatment B	Part 1: Treatment B>Treatment A	Part 2: Treatment A>Treatment B>Treatment B	Part 2: Treatment B>Treatment A>Treatment B	Part 2: Treatment B>Treatment B>Treatment A
Arm/Group Description	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.	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.	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.	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.	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.
Period Title: Overall Study
STARTED	6	6	21	21	20
COMPLETED	6	6	19	20	19
NOT COMPLETED	0	0	2	1	1

Baseline Characteristics

Arm/Group Title	Part 1: Treatment A>Treatment B	Part 1: Treatment B>Treatment A	Part 2: Treatment A>Treatment B>Treatment B	Part 2: Treatment B>Treatment A>Treatment B	Part 2: Treatment B>Treatment B>Treatment A	Total
Arm/Group Description	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.	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.	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.	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.	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.	Total of all reporting groups
Overall Participants	6	6	21	21	20	74
Age, Customized (Count of Participants)
<18 Years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
18-45 Years	0 0%	0 0%	4 19%	3 14.3%	5 25%	12 16.2%
45-65 Years	6 100%	6 100%	17 81%	18 85.7%	15 75%	62 83.8%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	6 100%	6 100%	21 100%	21 100%	20 100%	74 100%
Race/Ethnicity, Customized (Count of Participants)
White	6 100%	5 83.3%	18 85.7%	18 85.7%	17 85%	64 86.5%
Black or African American	0 0%	1 16.7%	3 14.3%	3 14.3%	3 15%	10 13.5%

Outcome Measures

1. Primary Outcome

Title	Corrected Area Under The Serum Concentration-time Profile From Time 0 to The Last Quantifiable Concentration (AUClast) of Total Testosterone (Part 1).
Description	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.
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.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	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 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.
Measure Participants	12	12
Geometric Mean (Geometric Coefficient of Variation) [nanogram*hour per milliliter (ng*hr/mL)]	1444 (62)	1362 (47)

2. Primary Outcome

Title	Corrected AUC From Tme 0 Extrapolated to Infinite Time (AUCinf) of Total Testosterone (Part 1).
Description	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.
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.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	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 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.
Measure Participants	9	10
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	1424 (66)	1392 (41)

3. Primary Outcome

Title	Corrected Maximum Observed Concentration (Cmax) of Total Testosterone (Part 1).
Description	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.
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.

Outcome Measure Data

Analysis Population Description

The analysis population included all participants randomized and treated who had at least 1 concentration in at least 1 treatment period.

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	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 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.
Measure Participants	12	12
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	8.834 (58)	8.193 (51)

4. Primary Outcome

Title	Corrected AUClast of Total Testosterone (Part 2).
Description	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.
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.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	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 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.
Measure Participants	59	60
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	1251 (59)	1384 (41)

5. Primary Outcome

Title	Corrected AUCinf of Total Testosterone (Part 2).
Description	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.
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.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	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 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.
Measure Participants	43	50
Geometric Mean (Geometric Coefficient of Variation) [ng*hr/mL]	1459 (44)	1493 (40)

6. Primary Outcome

Title	Corrected Cmax of Total Testosterone (Part 2)
Description	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.
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.

Outcome Measure Data

Analysis Population Description

The analysis population included all participants randomized and treated who had at least 1 concentration in at least 1 treatment period.

Arm/Group Title	Treatment A	Treatment B
Arm/Group Description	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 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.
Measure Participants	59	60
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	8.891 (61)	9.207 (50)

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.
Arm/Group Title	Treatment A (Parts 1 and 2)		Treatment B (Parts 1 and 2)
Arm/Group Description	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.		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.
All Cause Mortality
	Treatment A (Parts 1 and 2)		Treatment B (Parts 1 and 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/72 (0%)
Serious Adverse Events
	Treatment A (Parts 1 and 2)		Treatment B (Parts 1 and 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/71 (0%)		0/72 (0%)
Other (Not Including Serious) Adverse Events
	Treatment A (Parts 1 and 2)		Treatment B (Parts 1 and 2)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/71 (9.9%)		1/72 (1.4%)
Gastrointestinal disorders
Lip disorder	0/12 (0%)		1/12 (8.3%)
Infections and infestations
Nasopharyngitis	4/59 (6.8%)		0/60 (0%)
Injury, poisoning and procedural complications
Skin Abrasion	2/12 (16.7%)		0/12 (0%)
Investigations
Alanine aminotransferase increased	1/12 (8.3%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.