Researchers want to find out how Minocycline Extended-Release Tablets affect sperm-production in healthy males. The study will include Minocycline Extended-Release Tablets, a new once-daily formulation of minocycline, compared with a placebo or inactive pill. Approximately 170 healthy adult males will be assigned by chance (like flipping a coin) to 2 treatment groups with approximately 85 subjects per group. You will be treated with either Minocycline Extended-Release Tablets or placebo once daily. Screening will occur within 14 days prior to the first dose of study drug. Required study activities include: * Written informed consent * Weight * Two semen collections within 48-72 hours of one another at the screening visit and Days 84,112, 140, and 168 * Blood draws at the screening visit and Days 84, 112, 140, and 168 * Genital examination (excluding prostate) at screening and at the Day 84 and Day 112 visits * Medical history You will continue in the treatment phase of the study for 12 weeks. You will return to the clinic 4 weeks and 8 weeks after completion of the treatment phase of the study, with the final study visit approximately 12 weeks after the last dose. Participation will be for 24-weeks. Up to 10 investigational sites will enroll subjects into the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
1 mg/kg extended release minocycline HCL, once daily for 84 days.
placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.
West Coast Clinical Research
Tarzana, California, United States
University of Minnesota
Minneapolis, Minnesota, United States
Women's Health Research Center, LLC
Lawrenceville, New Jersey, United States
Weill Cornell Medical College
Great Neck, New York, United States
Maze Laboratories
Purchase, New York, United States
Tri-State Urologic Services, PSC, Inc.
Cincinnati, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
Urology San Antonio Research, PA
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Urology of Virginia, PC
Virginia Beach, Virginia, United States
Mean Percent Change From Screening in Sperm Concentration.
Time frame: Baseline and 12 Weeks
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