Status:
COMPLETED
A Study to Examine the Effects of Minocycline Extended-Release Tablets on Sperm Production in Human Males.
Lead Sponsor:
Medicis Pharmaceutical Corporation
Conditions:
Human Volunteer
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
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 formulati...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00765336
Start Date
November 1 2006
End Date
January 1 2009
Last Update
December 7 2011
Active Locations (10)
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1
West Coast Clinical Research
Tarzana, California, United States, 91356
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455-0341
3
Women's Health Research Center, LLC
Lawrenceville, New Jersey, United States, 08648
4
Weill Cornell Medical College
Great Neck, New York, United States, 11021