Phase II Randomized, Placebo-Controlled Double-Blind 4-Arm Trial for the Treatment of Non-Gonococcal Urethritis (NGU): Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)

Protocol Status: Enrolling

Title: Phase II Randomized, Placebo-Controlled Double-Blind 4-Arm Trial for the Treatment of Non-Gonococcal Urethritis (NGU): Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)

Design: Randomized, double-blind, four-arm trial. A stratified blocked randomization scheme will provide balanced allocation within site to doxycycline, doxycycline plus tinidazole, azithromycin, or azithromycin plus tinidazole.

Population: Males, ages 16-45 years, in good general health with non-gonococcal urethritis (NGU) attending STD clinics in Birmingham, AL; New Orleans, LA; Durham, NC; and Baltimore, MD

Duration: Participants will continue in the study until they complete a second follow-up visit at approximately 7 weeks or meet a protocol-defined reason for discontinuation.

Sample Size: 300 participants will be allocated to treatment arm by site: 3 sites will enroll 80 each; 1 site will enroll 60.

Primary Objectives: 1) For the treatment of NGU, compare the clinical cure rates of doxycycline versus doxycycline with tinidazole; and azithromycin versus azithromycin with tinidazole. 2) To evaluate the safety and tolerability of doxycycline/tinidazole and azithromycin/tinidazole in the treatment of NGU.