A Study to Examine the Effects of Minocycline Extended-Release Tablets on Sperm Production in Human Males.

Completed · Phase 4 · Has a placebo group

Conditions studied: Human Volunteer

In brief

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.

Key facts

Study ID

NCT00765336

Run by

Medicis Pharmaceutical Corporation

People needed

180

Starts

2006-11-01

Expected to finish

2009-01-01

Last updated by the study team

2011-12-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Males at least 18 years of age
• Weight 45 kg - 136.36 kg (99-300 lbs)
• Must understand and give consent voluntarily to be in the study and to comply with study requirements
• Subjects must ejaculate between 48 and 72 hours prior to collection of the first specimen (Pre-Collection Ejaculation) and refrain from further ejaculation until Specimen 1 is collected. The second ejaculation sample Specimen 2) must be collected between 48 hours and 72 hours after Specimen 1. No ejaculation is permitted between Specimen 1 and Specimen 2
• Must refrain from using saunas or hot tubs during the duration of the study 168 days)
• Must be a non smoker
• Must be medically healthy as determined by the investigator physician (via medical history and clinical laboratory tests)
• Must have sperm parameters (average of Specimen 1 and Specimen 2) within clinically acceptable limits at screening defined as:
• Total sperm concentration ≥20 x 106/mL10
• % motile ≥50%10
• % normal morphology >4.4%14

You may not qualify if…

• Known allergy/sensitivity to minocycline or any of the other drug product components
• Use of antacids or other dietary supplements containing aluminum, calcium, iron, or magnesium
• History of vestibular incidents including vertigo, lightheadedness, nausea, or vomiting within the 30 days prior to enrollment
• Known history of alcohol or drug dependency, significant within the past 2 years
• Known history or current risk of hepatic dysfunction
• Known history or current risk of renal dysfunction, e.g., uncontrolled diabetes
• Systemic lupus erythematosis (SLE) or a positive ANA at screening
• Receipt of any experimental drugs within 120 days prior to Study Day 0
• Non-LFT clinical laboratory values outside the normal range and determined to be of clinical significance
• Liver function tests greater than 1.5 times the upper limit of normal (ALT, AST, GGT)
• Use of tetracyclines, erythromycin within 12 weeks of Day 0

Where it is running

• 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

Full record on ClinicalTrials.gov

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