A Study to Examine the Effects of Minocycline Extended-Release Tablets on Sperm Production in Human Males.
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
- 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.
|Human Volunteer||Drug: minocycline extended release Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Minocycline Extended-Release Tablets on Spermatogenesis in Human Males|
- Mean Percent Change From Screening in Sperm Concentration. [ Time Frame: Baseline and 12 Weeks ]
|Study Start Date:||November 2006|
|Study Completion Date:||January 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: Minocycline Extended-Release Tablets||
Drug: minocycline extended release
1 mg/kg extended release minocycline HCL, once daily for 84 days.
|Placebo Comparator: Placebo||
placebo comparator for 1 mg/kg extended release minocycline HCL, once daily for 84 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765336
|United States, California|
|West Coast Clinical Research|
|Tarzana, California, United States, 91356|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455-0341|
|United States, New Jersey|
|Women's Health Research Center, LLC|
|Lawrenceville, New Jersey, United States, 08648|
|United States, New York|
|Weill Cornell Medical College|
|Great Neck, New York, United States, 11021|
|Purchase, New York, United States, 10577|
|United States, Ohio|
|Tri-State Urologic Services, PSC, Inc.|
|Cincinnati, Ohio, United States, 45212|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Urology San Antonio Research, PA|
|San Antonio, Texas, United States, 78229|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Urology of Virginia, PC|
|Virginia Beach, Virginia, United States, 23454|
|Study Chair:||Mary Sanstead, BSN, CCRP||Medicis Pharmaceutical|