A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
NCT03792477
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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).
2. Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).
3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
4. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
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.
9. 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.
10. 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.
11. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 56 days prior to dosing.
12. 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).
13. History of sensitivity to heparin or heparin induced thrombocytopenia.
14. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section
of this protocol.
15. 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.
16. 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.
17. Subjects with carcinoma of the breast.
18. Subjects with known or suspected carcinoma of the prostate gland.
19. Subjects who are hypersensitive to testosterone cypionate or its inactive ingredients.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- DeLand, Florida
- Miami, Florida
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males | ||||||
Official Title ICMJE | 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 | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | 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 formulation Masking: None (Open Label)Primary Purpose: Other | ||||||
Condition ICMJE | Hypogonadism | ||||||
Intervention ICMJE |
| ||||||
Study Arms ICMJE |
| ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 74 | ||||||
Original Estimated Enrollment ICMJE | 56 | ||||||
Actual Study Completion Date ICMJE | April 2, 2020 | ||||||
Actual Primary Completion Date | April 2, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03792477 | ||||||
Other Study ID Numbers ICMJE | B5341002 DEPO-T BE STUDY ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
| ||||||
IPD Sharing Statement ICMJE |
| ||||||
Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Pfizer | ||||||
Verification Date | May 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |