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

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 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.

Timeline

Start

2006-11

Primary completion

2008-12

Completion

2009-01

Drugs

Indications

No indication recorded.