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

Who is this study for? Patients with Hypogonadism
What treatments are being studied? Aveed Injectable Product, Fortesta or Testim
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 nanograms (ng)/deciliters (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 to reveal shifts in blood pressure levels.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: No
View:

• Have a diagnosis of primary hypogonadism or hypogonadotropic hypogonadism.

• Have a total serum testosterone at screening < 300 ng/dL based on 2 blood samples obtained at 10 am (+/-2 hours) on 2 separate occasions at least 48 hours apart

• Be naïve to androgen replacement or washout of 12 weeks following intramuscular androgen injections; 4 weeks following topical or buccal, nasal, or oral androgens.

• Have a screening blood pressure at rest of less than 140 millimeters of mercury (mm Hg) for systolic blood pressure and less than 90 mm Hg for diastolic blood pressure.

• Be judged to be in good health.

• Participants 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.

• Be willing and able to cooperate with the requirements of the study.

Locations
United States
Alabama
Endo Clinical Trial Site #8
Recruiting
Birmingham
Arkansas
Endo Clinical Trial Site #15
Recruiting
North Little Rock
Arizona
Endo Clinical Trial Site #22
Recruiting
Tucson
California
Endo Clinical Trial Site #32
Recruiting
Bell Gardens
Endo Clinical Trial Site #33
Recruiting
Canoga Park
Florida
Endo Clinical Trial Site #30
Recruiting
Beverly Hills
Endo Clinical Trial Site #12
Recruiting
Boynton Beach
Endo Clinical Trial Site #34
Recruiting
Boynton Beach
Endo Clinical Trial Site #29
Recruiting
Fleming Island
Endo Clinical Trial Site #2
Recruiting
Miami
Endo Clinical Trial Site #26
Recruiting
Miami
Endo Clinical Trial Site #28
Recruiting
Miami
Endo Clinical Trial Site #10
Recruiting
Miami Beach
Endo Clinical Trial Site #18
Recruiting
Miami Gardens
Endo Clinical Trial Site #3
Recruiting
Oviedo
Endo Clinical Trial Site #4
Recruiting
Pembroke Pines
Endo Clinical Trial Site #11
Recruiting
Pompano Beach
Endo Clinical Trial Site #23
Recruiting
West Palm Beach
Illinois
Endo Clinical Trial Site #16
Recruiting
Chicago
Maryland
Endo Clinical Trial Site #27
Recruiting
Glen Burnie
Endo Clinical Trial Site #17
Recruiting
Towson
North Carolina
Endo Clinical Trial Site #25
Recruiting
Winston-salem
New Jersey
Endo Clinical Trial Site #35
Recruiting
East Orange
New York
Endo Clinical Trial Site #9
Recruiting
Garden City
Endo Clinical Trial Site #7
Recruiting
New York
Ohio
Endo Clinical Trial Site #5
Recruiting
Dayton
Pennsylvania
Endo Clinical Trial Site #13
Recruiting
Bala-cynwyd
Texas
Endo Clinical Trial Site #19
Recruiting
Houston
Endo Clinical Trial Site #20
Recruiting
Houston
Endo Clinical Trial Site #31
Recruiting
Houston
Endo Clinical Trial Site #21
Recruiting
Missouri City
Endo Clinical Trial Site #1
Recruiting
San Antonio
Virginia
Endo Clinical Trial Site #6
Recruiting
Charlottesville
Endo Clinical Trial Site #24
Recruiting
Virginia Beach
Vermont
Endo Clinical Trial Site #14
Recruiting
Rutland
Contact Information
Primary
Trudy Luxana
ClinicalTrials@Endo.com
800-462-3636
Backup
Clinical Operations
ClinicalTrials@Endo.com
800-462-3636
Time Frame
Start Date: June 30, 2020
Estimated Completion Date: December 7, 2022
Participants
Target number of participants: 618
Treatments
Active Comparator: AVEED (Testosterone Undecanoate Injection)
Fixed dosage level of 750 milligrams (mg)/3 milliliters (mL) administered by intramuscular injections.
Active Comparator: FORTESTA (Testosterone Gel)
40 mg once daily topical gel administration.
Active Comparator: TESTIM (Testosterone Gel)
50 mg once daily topical gel administration.
Sponsors
Leads: Endo Pharmaceuticals

This content was sourced from clinicaltrials.gov

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