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A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456296
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:

Testosterone is the principal androgen produced by the male testes. Hypogonadism is the result of inadequate production of testosterone by the Leydig cells of the testes and is reflected by total serum concentrations of testosterone of < 300 ng/dL, with discernible diurnal pattern. The etiology of hypogonadism may be primary or secondary. The treatment of males with primary, and in some cases, secondary Hypogonadism includes administration of testosterone.

Testim® and Fortesta® are topical gels that when applied daily help to increase the total testosterone levels in the blood through skin absorption. Aveed® is an injectable form of testosterone treatment and participants randomized to this treatment arm will receive 3 injections over the course of 16 weeks.

This study is designed to evaluate the effect on blood pressure of approved testosterone products (Testim®, Fortesta®, and Aveed®) after 16 weeks of therapy using 24-hour Ambulatory blood pressure (ABPM) to reveal shifts in BP levels.


Condition or disease Intervention/treatment Phase
Hypogonadism Hypogonadism, Male Hypogonadotropic Hypogonadism Drug: Aveed Injectable Product, Fortesta or Testim Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 729 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Parallel-Group, Three Treatment Arm, Multicenter Study on Hypogonadal Males to Evaluate the Effect on 24-Hour Ambulatory Blood Pressure After 16-Week Continuous Administration With Marketed Testosterone Products
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : December 7, 2022
Estimated Study Completion Date : December 7, 2022


Arm Intervention/treatment
Active Comparator: Testosterone undecanoate injection (AVEED)
Fixed dosage level of 750mg/3mL
Drug: Aveed Injectable Product, Fortesta or Testim
Depending on the treatment arm, the daily dose of the study drug will be either a fixed dosage or titrated for each subject, according to approved dosage and administration instructions, if necessary, until the circulating testosterone concentrations of the subject reaches normal concentrations (300-1000 ng/dL).

Active Comparator: Testosterone gel (FORTESTA)
40mg once daily
Drug: Aveed Injectable Product, Fortesta or Testim
Depending on the treatment arm, the daily dose of the study drug will be either a fixed dosage or titrated for each subject, according to approved dosage and administration instructions, if necessary, until the circulating testosterone concentrations of the subject reaches normal concentrations (300-1000 ng/dL).

Active Comparator: Testosterone gel (TESTIM)
50mg once daily (titrated)
Drug: Aveed Injectable Product, Fortesta or Testim
Depending on the treatment arm, the daily dose of the study drug will be either a fixed dosage or titrated for each subject, according to approved dosage and administration instructions, if necessary, until the circulating testosterone concentrations of the subject reaches normal concentrations (300-1000 ng/dL).




Primary Outcome Measures :
  1. Change from Baseline to end of Treatment in 24-hour average systolic ambulatory blood pressure (BP). [ Time Frame: Approximately 16 weeks after initiation of treatment ]

Secondary Outcome Measures :
  1. Mean change from baseline in 24-hour average and time windows of interest in mean arterial pressure (MAP) [ Time Frame: Approximately 16 weeks after initiation of treatment ]
    Mean change from baseline in 24-hour average and time windows of interest in mean arterial pressure (MAP)

  2. Mean change from baseline in 24-hour averages and time windows of interest in systolic blood pressure (SBP) [ Time Frame: Approximately 16 weeks after initiation of treatment ]
    Mean change from baseline in 24-hour averages and time windows of interest in systolic blood pressure SBP)

  3. Mean change from baseline in 24-hour averages and time windows of interest in diastolic blood pressure (DBP) [ Time Frame: Approximately 16 weeks after initiation of treatment ]
    Mean change from baseline in 24-hour averages and time windows of interest in diastolic blood pressure (DBP)

  4. Mean change from baseline in 24-hour averages and time windows of interest in heart rate [ Time Frame: Approximately 16 weeks after initiation of treatment ]
    Mean change from baseline in 24-hour averages heart rate

  5. Mean change from baseline in 24-hour averages and time windows of interest in pulse pressure [ Time Frame: Approximately 16 weeks after initiation of treatment ]
    Mean change from baseline in 24-hour averages and time windows of interest in pulse pressure (PP)

  6. Change from baseline over time (hourly average) by nominal clock time and time after dose in mean arterial pressure (MAP) [ Time Frame: Approximately 16 weeks after initiation of treatment ]
    Change from baseline over time (hourly average) by nominal clock time and time after dose in mean arterial pressure (MAP)

  7. Change from baseline over time (hourly average) by nominal clock time and time after dose in systolic blood pressure (SBP) [ Time Frame: Approximately 16 weeks after initiation of treatment ]
    Change from baseline over time (hourly average) by nominal clock time and time after dose in systolic blood pressure (SBP)

  8. Change from baseline over time (hourly average) by nominal clock time and time after dose in diastolic blood pressure (DBP) [ Time Frame: Approximately 16 weeks after initiation of treatment ]
    Change from baseline over time (hourly average) by nominal clock time and time after dose in diastolic blood pressure (DBP)

  9. Change from baseline over time (hourly average) by nominal clock time and time after dose in pulse pressure [ Time Frame: Approximately 16 weeks after initiation of treatment ]
    Change from baseline over time (hourly average) by nominal clock time and time after dose in pulse pressure (PP)

  10. Change from baseline over time (hourly average) by nominal clock time and time after dose in heart rate [ Time Frame: Approximately 16 weeks after initiation of treatment ]
    Change from baseline over time (hourly average) by nominal clock time and time after dose in heart rate (HR)

  11. Percent of subjects with new antihypertensive medications [ Time Frame: Approximately 16 weeks after initiation of treatment ]
    Percent of subjects with new antihypertensive medications

  12. Percent of subjects with dose increases in antihypertensive medications [ Time Frame: Approximately 16 weeks after initiation of treatment ]
    Percent of subjects with dose increases in antihypertensive medications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have a diagnosis of primary hypogonadism OR hypogonadotropic hypogonadism.
  2. Have a total serum testosterone at screening < 300 ng/dL based on 2 blood samples obtained at 10am(+/-2hr) on 2 separate occasions at least 48 hrs apart
  3. Be naïve to androgen replacement or washout of 12 weeks following intramuscular androgen injections; 4 weeks following topical or buccal, nasal, or oral androgens.
  4. Have a screening Blood Pressure at rest of less than 140 mm Hg for Systolic Blood Pressure and less than 90 mm Hg for Diastolic Blood Pressure.
  5. Be judged to be in good health.
  6. Subjects enrolled in the Testim or Fortesta treatment arms: take necessary precautions to avoid skin-to-skin contact and potential transfer and if male use effective contraception.
  7. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

  1. Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
  2. Has a history of significant sensitivity or allergy to the study drugs, including androgens, or product excipients.
  3. Has a history of or medical examination findings renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric conditions, cardiovascular disease/dysrhythmia) or any other condition(s) that restricts study participation.
  4. Has clinically significant changes in any medications (including dosages) or medical conditions in the 28 days prior to screening
  5. Is not on a stable medication regimen for at least 3 months for the treatment of a chronic condition.
  6. Has had a cardiovascular and/or cerebrovascular event within the last 6 months.
  7. Needs Blood Pressure cuff size larger than 50 cm.
  8. Works a night shift or performs heavy manual labor.
  9. Has any known contraindication(s) to active study treatment including, but not limited to: known or suspected carcinoma of the prostate or breast, previous history of cancer (except basal cell carcinoma of the skin) liver disease, active deep vein thrombosis, atrial fibrillation, untreated sleep apnea, or is immune compromised.
  10. Uses known inhibitors (eg, ketoconazole) or inducers of cytochrome P450 3A (eg, dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior to study drug administration and through the end of the study.

    1. Uses any of the above listed drugs within 5 half lives of the last dose in the past 6 months prior to study drug administration.
    2. Has received any of the above listed drugs by injection within 30 days or 10 half lives (whichever is longer) prior to study drug administration.
    3. Uses Neutraceuticals or homeopathic compounds.
  11. Has a history of drug or alcohol abuse within 6 months prior to study drug administration.
  12. Has untreated moderate to severe depression.
  13. Has any skin lesions/cuts/injury at the application site.
  14. Has suspected reversible hypogonadism.
  15. Donated blood or blood products or experienced significant blood loss within 90 days prior to study drug administration.
  16. Intends to conceive at any time during the study.
  17. Donated bone marrow within 6 months prior to study drug administration.
  18. Has participated in a previous investigational study or received treatment with an investigational product within 30 days of screening.
  19. Has a diagnosis of, is undergoing therapy for, or has received therapy for a hematologic malignancy in the 5 years prior to screening.
  20. Has a history of substance abuse or is taking any substance of abuse (Note: subjects on a stable dose of any medications that have been prescribed by a healthcare practitioner for a properly documented medical condition are exempt).
  21. Abnormal ECG (QT prolongation with QTc ≥450 ms).
  22. Has evidence of abnormalities on physical examination, vital signs, ECG, or clinical lab values, unless judged to be clinically insignificant by the investigator
  23. Has any other condition that might indicate the subject to be unsuitable for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456296


Contacts
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Contact: Deanna Lutte 800-462-3636 ClinicalTrials@Endo.com
Contact: Amy Lovell 800-462-3636 ClinicalTrials@Endo.com

Locations
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United States, Alabama
Endo Clinical Trial Site #8 Recruiting
Birmingham, Alabama, United States, 35235
United States, Florida
Endo Clinical Trial Site #12 Recruiting
Boynton Beach, Florida, United States, 33435
Endo Clinical Trial Site #10 Recruiting
Miami Beach, Florida, United States, 33140
Endo Clinical Trial Site #2 Recruiting
Miami, Florida, United States, 33014
Endo Clinical Trial Site #3 Recruiting
Oviedo, Florida, United States, 32765
Endo Clinical Trial Site #4 Recruiting
Pembroke Pines, Florida, United States, 33027
Endo Clinical Trial Site #11 Recruiting
Pompano Beach, Florida, United States, 33060
United States, New York
Endo Clinical Trial Site #9 Recruiting
Garden City, New York, United States, 11530
Endo Clinical Trial Site #7 Recruiting
New York, New York, United States, 10016
United States, Ohio
Endo Clinical Trial Site #5 Recruiting
Dayton, Ohio, United States, 45417
United States, Pennsylvania
Endo Clinical Trial Site #13 Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004
United States, Texas
Endo Clinical Trial Site #1 Recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
Endo Clinical Trial Site #6 Recruiting
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Karen Kang Endo Pharmaceuticals
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04456296    
Other Study ID Numbers: EN3000-101
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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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:
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Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents